Preoperative biofeedback improves continence recovery after open prostatectomy: a systematic review and meta-analysis
10.54103/dn/20383
BACKGROUND: L'incontinenza urinaria postoperatoria è il risultato complessivo dell'incompetenza dello sfintere uretrale e delle modifiche della lunghezza dell'uretra dopo la prostatectomia radicale. I risultati degli interventi preoperatori mirati a prevenire l'incontinenza post-prostatectomia includono l'allenamento preoperatorio dei muscoli del pavimento pelvico (PFMT) e il biodfeedback (BFB), che possono essere gestiti dal personale infermieristico in molti Paesi.
OBIETTIVO: determinare l'efficacia del biofeedback preoperatorio (BFB) per l'incontinenza urinaria post-prostatectomia rispetto al training pelvico senza BFB, considerando la variabilità dei risultati degli studi disponibili.&nbsp;
METODI: è stata condotta una revisione sistematica con meta-analisi, analizzando le indicazioni fornite dalla letteratura sul biofeedback preoperatorio per la prevenzione dell'incontinenza urinaria in termini di regimi di trattamento, tempi di inizio delle sessioni, numero di esercizi di contrazione e rilassamento e lavoro programmato a casa. La ricerca della letteratura è stata effettuata su Pubmed, CINAHL, Cochrane Library, Web of Science, Scopus, EMBASE e PEdro.
RISULTATI: nonostante solo tre articoli siano stati adatti alla metanalisi, i nostri risultati supportano il BFB rispetto alle istruzioni scritte per il recupero della continenza dopo 3 e 6 mesi dall'intervento. L'implementazione di programmi progressivi con molti esercizi muscolari diversi e l'inclusione del rilassamento sono le principali raccomandazioni.
CONCLUSIONI: Il biofeedback preoperatorio porta a un miglioramento della continenza urinaria dopo 3 e 6 mesi dalla prostatectomia radicale. Gli studi futuri dovrebbero concentrarsi sulle caratteristiche e sul numero di contrazioni muscolari pelviche richieste durante il biofeedback per massimizzare l'efficacia.Il biofeedback preoperatorio migliora il recupero della continenza dopo la prostatectomia aperta: una revisione sistematica e una meta-analisi
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Il biofeedback preoperatorio migliora il recupero della continenza a seguito di prostatectomia radicale: una revisione sistematica con meta-analisi
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Bernalte-Martí V. Cross-cultural Adaptation of the Safety Attitudes Questionnaire Short Form in Spanish and Italian Operating Rooms: Psychometric Properties. J Patient Saf. 2022;18(3). DOI: 10.1097/PTS.0000000000000902.
Il biofeedback preoperatorio migliora il recupero della continenza a seguito di prostatectomia radicale: una revisione sistematica con meta-analisi
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  Preoperative biofeedback improves continence recovery after open
       prostatectomy: a systematic review and meta-analysis
                   1
Stefano Terzoni        , Mauro Parozzi1, Bernardo Rocco2, Chiara Sighinolfi3, Giorgia Gaia3, Laura Di Prisco1, Lara Carelli1,
                  1               1                                1         3                        3                      1
Roberta Lodini , Elena Sala , Agostino D’Antuono , Cristina Mora , Serena Maruccia , Paolo Ferrara
1 BachelorSchool of Nursing, ASST Santi Paolo e Carlo, Milan, Italy
2 Department  of Health Sciences, University of Milan, Milan, Italy
3 ASST Santi Paolo e Carlo, Milan, Italy




Findings:                                            ABSTRACT
Preoperative biofeedback seems to                    BACKGROUND: Postoperative urinary incontinence is the overall result of
lead to improved urinary continence                  urethral sphincter incompetence and modifications in urethral length after radical
after open prostatectomy.                            prostatectomy. Findings for preoperative interventions targeted at preventing post-
                                                     prostatectomy incontinence include preoperative pelvic floor muscle training
                                                     (PFMT) and biodfeedback (BFB), which can be managed by nurses in many
                                                     countries and have been used for decades to speed up continence recovery after
                                                     surgery.

                                                     AIM: We investigated the indications provided by the literature regarding
                                                     preoperative biofeedback for preventing urinary incontinence after open radical
                                                     prostatectomy, in terms of treatment regimens, timing for beginning the sessions,
                                                     number of contraction and relaxation exercises, and scheduled work at home. We
                                                     aimed to determine the effectiveness of preoperative biofeedback (BFB) for post-
                                                     prostatectomy urinary incontinence compared to pelvic training without BFB,
                                                     considering the variability between the results of the available studies.

                                                     METHODS: A systematic review and meta-analysis was conducted. Literature
                                                     search on Pubmed, CINAHL, Cochrane Library, Web of Science, Scopus,
                                                     EMBASE, and PEdro.

                                                     RESULTS: Despite only three papers being suitable for metanalysis, our results
                                                     support BFB over written instructions for continence recovery after both 3 and 6
                                                     moths from surgery. Implementing progressive programs with many different
                                                     muscular exercises and including relaxation are the main recommendations.

                                                     CONCLUSIONS: Preoperative biofeedback leads to improved urinary continence
                                                     after 3 and 6 months from radical prostatectomy. Future studies should focus on
                                                     the characteristics and number of pelvic muscle contractions required during
                                                     biofeedback in order to maximize effectiveness.




                       KEYWORDS: Pelvic Floor; Open Prostatectomy; Urinary Incontinence; Rehabilitation Nursing

        Corresponding author:                                           52                                  Submission received: 23/06/2023
        Stefano Terzoni: stefano.terzoni@asst-santipaolocarlo.it                                     End of Peer Review process: 28/07/2023
        Via Ovada 26, 20142 Milano, Italy                                                                             Accepted: 30/07/2023

                                                                                  This work is licensed under a Creative Commons
                                                                                  Attribution-NonCommercial-NoDerivatives 4.0 nternational
           ISSN: 2785-7263                                                                                            DOI: 10.54103/dn/20383




 Il biofeedback preoperatorio migliora il recupero della continenza a seguito
      di prostatectomia radicale: una revisione sistematica e meta-analisi
                     1
 Stefano Terzoni    , Mauro Parozzi1, Bernardo Rocco2, Chiara Sighinolfi3, Giorgia Gaia3, Laura Di Prisco1, Lara
        1                1            1                    1               3                  3               1
 Carelli , Roberta Lodini , Elena Sala , Agostino D’Antuono , Cristina Mora , Serena Maruccia , Paolo Ferrara
 1 Corsodi Laurea in Infermieristica, ASST Santi Paolo e Carlo, Milano
 2 Dipartimento di Scienze della Salute, Università degli Studi di Milano
 3 ASST Santi Paolo e Carlo, Milano




Riscontri:                                           ABSTRACT
Il biofeedback preoperatorio sembra                  INTRODUZIONE: L'incontinenza urinaria postoperatoria è il risultato
migliorare la continenza urinaria dopo               complessivo dell'incompetenza dello sfintere uretrale e delle modifiche della
prostatectomia radicale.                             lunghezza dell'uretra dopo la prostatectomia radicale. I risultati degli interventi
                                                     preoperatori mirati a prevenire l'incontinenza post-prostatectomia includono
                                                     l'allenamento preoperatorio dei muscoli del pavimento pelvico (PFMT) ed il
                                                     biodfeedback (BFB), che possono essere gestiti dal personale infermieristico in molti
                                                     Paesi e sono stati utilizzati per decenni per accelerare il recupero della continenza
                                                     dopo l'intervento.

                                                     OBIETTIVO: sono state analizzate le indicazioni fornite dalla letteratura sul
                                                     biofeedback preoperatorio per la prevenzione dell'incontinenza urinaria dopo la
                                                     prostatectomia radicale aperta, in termini di regimi di trattamento, tempi di inizio
                                                     delle sessioni, numero di esercizi di contrazione e rilassamento e lavoro programmato
                                                     a casa. Il nostro obiettivo è stato quello di determinare l'efficacia del biofeedback
                                                     preoperatorio (BFB) per l'incontinenza urinaria post-prostatectomia rispetto al
                                                     training pelvico senza BFB, considerando la variabilità dei risultati degli studi
                                                     disponibili.

                                                     METODI: È stata condotta una revisione sistematica con meta-analisi. La ricerca
                                                     della letteratura è stata effettuata su Pubmed, CINAHL, Cochrane Library, Web of
                                                     Science, Scopus, EMBASE e PEdro.

                                                     RISULTATI: Nonostante solo tre articoli fossero adatti alla metanalisi, i nostri
                                                     risultati supportano il BFB rispetto alle istruzioni scritte per il recupero della
                                                     continenza dopo 3 e 6 mesi dall'intervento. L'implementazione di programmi
                                                     progressivi con molti esercizi muscolari differenti e l'inclusione del rilassamento sono
                                                     le principali raccomandazioni.

                                                     CONCLUSIONI: Il biofeedback preoperatorio porta a un miglioramento della
                                                     continenza urinaria dopo 3 e 6 mesi dalla prostatectomia radicale. Gli studi futuri
                                                     dovrebbero concentrarsi sulle caratteristiche e sul numero di contrazioni muscolari
                                                     pelviche richieste durante il biofeedback per massimizzare l'efficacia.



               KEYWORDS: Pavimento Pelvico; Prostatectomia Radicale; Incontinenza Urinaria; Infermieristica Riabilitativa

        Corresponding author:                                               53                               Submission received: 23/06/2023
        Stefano Terzoni: stefano.terzoni@asst-santipaolocarlo.it                                      End of Peer Review process: 28/07/2023
        Via Ovada 26, 20142 Milano, Italy                                                                              Accepted: 30/07/2023

                                                                                   This work is licensed under a Creative Commons
                                                                                   Attribution-NonCommercial-NoDerivatives 4.0 nternational
        ISSN: 2785-7263                                                                                       DOI: 10.54103/dn/20383




BACKGROUND                                                             countries and have been used for decades to speed up
Prostate cancer is the most common form of malignant                   continence recovery after surgery. PFMT consists of
neoplasm in men aged 50 or more [1] and radical                        voluntary contractions of the levator ani muscle, aimed at
prostatectomy (RP) is the first-choice surgical treatment              improving strength and endurance of the pubocyccigeal
for organ-limited prostate cancer, according to the                    muscle, which can help urethral closure if properly trained.
European guidelines with over 90% of 15-year disease-                  BFB consists in the elecromyographical detection of pelvic
specific survival [1]. Urinary incontinence is a common                muscles contraction, by using surface electrodes or rectal
complication of RP, with prevalence ranging in literature              probes connected to a computer. It is widely used for
from 4-8% to 59-63% [1] depending on the surgical                      teaching patients the correct way of contracting pelvic
technique, definition of continence chosen, measurement                muscles during PFMT [8]. Almost all BFB machines allow
techniques for quantifying actual leakages, and follow-up              the operator to choose between simply visualizing the
timing.                                                                electrical potential generated by muscular contraction and
                                                                       preparing a programme of “obstacles” with precise shape,
Continence is the result of a complex mechanism of                     heigth, and length. Obstacles are depicted on screen by the
muscles working together: the proximal urethral sphincter,             computer and can have different shapes such as triangular
the levator ani muscular group and the rhabdosphincter all             or square. Each shape requires the patient to perform a
contribute to urinary control, all regulated by complex                specific type of contraction: for example, to overcome a
neurophysiological mechanisms [2]. Radical prostatectomy               triangle-shaped obstacle, the patient needs to perform a
damages several of the structures that contribute to                   fast contraction and release. Any contraction causes an
continence: the proximal sphincter is almost completely                increase of the electromiographic line on screen, due to
removed, so that postoperative continence mainly depends               the increase in the electrical potential during contractions.
on the rhabdosphincter which can get damaged as well,                  Therefore, it is possible to check if the patient is correctly
due to his proximity to the prostate. Some authors have                activating the pelvic muscles, by simply verifying if the
shown that up to 92% of patients with post-prostatectomy               electromiographic line follows the shape of the obstacle.
incontinence have autonomic denervation of the urethral                This allows precise tuning of pelvic training, because the
mucosa, which suggests that the nervous bundle of the                  characteristics of the obstacles require the patient to
rhabdosphincter, more than the sphincter itself, is the                contract phasic and tonic fibers with specific criteria of
crucial point [3]. Postoperative urinary incontinence is the           intensity, duration, and number of repetitions, thus
overall result of urethral sphincter incompetence and                  increasing strength, endurance, and resistance.
modifications in urethral length. Urodynamic testing by
urethral pressure profilometry shows that maximum                      Two old meta-analyses by Wang et al. [7] and Chang et al.
urethral closure pressure is reduced by a median of 41%                [8] have studied the role of preoperative PFMT; in some
after radical retropubic prostatectomy (RRP) [4].                      of the studies they considered, BFB had been used as a
Furthermore, being the bladder affected by the surgical                prehabilitation method, but the metanalyses did not make
operation as well, patients can experience consequences on             a distinction between PFMT alone and PFMT+BFB.
detrusor innervation and function [5] although there is                While Wang and colleagues found no conclusive evidence
little agreement in literature about this finding. Detrusor            about PFMT before open prostatectomy, Chang and
overactivity has been reported as an independent predictor             colleagues included new studies in their paper, in addition
of postoperative incontinence in men [6].                              to those considered by Wang et al., and found that
                                                                       preoperative PFMT improved postoperative urinary
Over the past decade, findings for preoperative                        incontinence by 36% at three months (OR=.64,
interventions targeted at preventing post-prostatectomy                95%CI[.47-.88]) but not at six months. Another
incontinence (“prehabilitation”) have become available in              metanalysis has been published in 2021 [9] which however
the literature [7]. Such interventions include preoperative            did not add any significant information about biofeedback
pelvic floor muscle training (PFMT) and biodfeedback                   compared to the previous two. To date, the work by
(BFB) [7] which can be managed by nurses in many                       Chang et al. appears to be the most complete investigation
       Corresponding author:                                      54                                 Submission received: 23/06/2023
       Stefano Terzoni: stefano.terzoni@asst-santipaolocarlo.it                               End of Peer Review process: 28/07/2023
       Via Ovada 26, 20142 Milano, Italy                                                                       Accepted: 30/07/2023

                                                                           This work is licensed under a Creative Commons
                                                                           Attribution-NonCommercial-NoDerivatives 4.0 nternational
        ISSN: 2785-7263                                                                                        DOI: 10.54103/dn/20383




of this topic. However, some of the papers in the meta-                continence is obviously of great interest for patients and
analysis only studied PFMT alone, while others have used               for healthcare providers, as relapses on incontinence are
BFB in addition to PFMT compared to written                            sometimes possible [16] and therefore it is interesting to
instructions on how to perform pelvic training;                        study the longest possible follow-up periods.
furthermore, several comparisons were performed by the
authors of the primary papers, as some used written or                 Aims
vebal instructions on how to perform PFMT as control.
                                                                       To update and summarize the evidence regarding
Some of the papers included in the meta-analysis have
                                                                       preoperative BFB for reducing post-prostatectomy urinary
recommended preoperative biofeedback [10–12] while
                                                                       incontinence; to provide practical indication regarding the
others have not [13,14]. Considering that BFB is a
                                                                       characteristics of the treatment that proved useful in
treatment requiring a dedicated machine, a trained
                                                                       relevant literature.
professional, and a rectal probe that can be discomfortable
for patients, it would be interesting to know whether
adding BFB to PFMT leads to any improvement of
postoperative continence compared to written instructions              METHODS:
provided to patients, as done in several of the papers
                                                                       Design
included in the existing metanalyses. Cheng and colleagues
have not performed this type of comparison. Furthermore,               We conducted a systematic review of the literature
recent literature [15,16] has shown a strong the                       according to the methodology described by Palmer and
relationship between the characteristics of exercise                   Sterne [20]. The PICO question (Patients, Intervention,
regimens (and therefore the methods used for teaching                  Control, Outcome) was: P=patients undergoing radical
them) and the results: for this reason, the fact that BFB is           prostatectomy, I=preoperative BFB supervised by a
always useful for teaching PFMT should not be taken for                trained professional, C=PFMT, O=postoperative urinary
granted, nor should it be considered obvious that, if                  incontinence”. An additional relevant question was “What
preoperative PFMT is useful, BFB will give good results as             are the indications provided by the literature regarding
well.                                                                  preoperative biofeedback for preventing urinary
                                                                       incontinence after radical prostatectomy, in terms of
The available evidence regarding prehabilitation with BFB
                                                                       treatment regimens, timing for beginning the sessions,
only regards open prostatectomy; several trials are
                                                                       number of contraction and relaxation exercises, and
available, all suggesting different prehabilitation regimens
                                                                       scheduled work at home?”
and achieving different results. Notwithstanding the
spreading of robot-assisted and minimally-invasive                     PubMed, CINAHL, The Cochrane Library, SCOPUS,
technologies, open techniques are still largely used                   EMBASE, and Web of Science were searched with the
(especially in centres which, due to the low volume of                 keywords preoperative, prostatectomy, “urinary incontinence”,
surgery performed, would not be able to economically                   prevention, exercise, “pelvic floor muscle training”, biofeedback.
sustain the costs of robotic surgery) as testified by the              Whenever possible, thesaurus keywords were used. Paper
numerous papers published in recent years about the                    sources such as monographies, printed journals and
chracterics of this approach [17] and its consequences on              scientific books were searched as well, by accessing the
urinary continence [18], these latter being matter of                  academic library of our teaching hospital. The literature
investigation in a systematic review [19]. This poses a                search was stopped on April 15, 2022; this search was
rationale for conducting a metanalysis of studies regarding            registered on XXX (concealed for blinded review) with a
open techniques in 2020.                                               publicly accessible protocol. This study had no funding
                                                                       source and the authors did not have any competing
Overall, additional research is required to clarify the role of
                                                                       interest.
preoperative biofeedback and the characteristics it should
have to grant continence in the long run. Long-term
       Corresponding author:                                      55                                  Submission received: 23/06/2023
       Stefano Terzoni: stefano.terzoni@asst-santipaolocarlo.it                                End of Peer Review process: 28/07/2023
       Via Ovada 26, 20142 Milano, Italy                                                                        Accepted: 30/07/2023

                                                                            This work is licensed under a Creative Commons
                                                                            Attribution-NonCommercial-NoDerivatives 4.0 nternational
        ISSN: 2785-7263                                                                                       DOI: 10.54103/dn/20383




Inclusion criteria                                                     studies included in the meta-analysis). Studies with a
                                                                       Cook's distance larger than the median plus six times the
We included interventional studies published since 2000,               interquartile range of the Cook's distances were considered
considering that the very first papers on preoperative                 influential. The rank correlation test and the regression
biofeedback were published in the early 2000s. The                     test, using the standard error of the observed outcomes as
included studies we analyzed have enroled patients of all              predictor, were used to check for funnel plot asymmetry
ages undergoing radical prostatectomy (any technique) for              and subsequent risk of publication bias. To allow easier
prostate cancer staged ≤ T3, which according to the TNM                quantification of the clinical advantage obtained with BFB,
staging (Tumour, lymhNodes, Metastatis) corresponds to                 odds ratios were calculated byexponential transformation
intracapsular tumour [1]. Interventions had to involve                 of the original log odds ratios, and presented in the forest
preoperative PFMT with biofeedback (auditory, visual, or               plots reported in this paper.
tactile). Studies of which the full text could not be
retrieved were excluded. We relied on the university library           All calculations were performed with STATA® 17 for
for retrieving the highest possible number of full text                MacOS (StataCorp, Inc.).
papers. The flow of studies selection was reported
according to the PRISMA (Preferred Reporting Items for
Systematic Reviews and Meta-analyses) statement [21].
                                                                       RESULTS

                                                                       We retrieved a total of 238 papers, 135 of which were
Study assessment
                                                                       excluded after reading the abstracts. Of the 73 remaining,
The characteristics of the studies were assessed by two                68 were excluded after reading the full text because they
authors using the PEDRO (Physiotherapy Evidence                        were duplicates or failed to fulfill the required design or
Database) scale [22] which has been expressely created for             enrolment criteria. Finally, 5 trials were included in this
rehabilitation studies; the Rayyan platform was used to                review (10–14). Figure 1 shows the flowchart of literature
allow independent judgement of the papers by the two                   selection. All studies were compliant with the items of the
authors.                                                               PEDRO scale, apart for blinding which in this review was
                                                                       inappropriate due to the nature of treatments.
                                                                       Notwithstanding        this    positive     methodological
Statistical analysis                                                   characteristic, the papers showed differences regarding the
                                                                       definition of continence chosen by the authors, the
The analysis was carried out using the log odds ratio as the           characteristics of the biofeedback programs, and the
outcome measure, which was postoperative continence. A                 timing of interventions and follow-up. Similarly to Chang
random-effects model was fitted to the data. The amount                et al. (2015) we chose continence as the outcome of our
of heterogeneity (i.e., tau²), was estimated using the                 analysis, defined as the absence of involuntary leakages
restricted maximum-likelihood estimator. In addition to                [23]. Only one study [10] underwent power analysis. Some
the estimate of tau², the Q-test for heterogeneity and the I²          had very small sample size [12]; in most papers, no
statistic were reported. In case any amount of                         information regarding effect size of the intervention was
heterogeneity is detected (i.e., tau² > 0, regardless of the           included. Only one paper [24] enrolled patients undergoing
results of the Q-test), a prediction interval for the true             laparoscopic prostatectomy; no studies on robotic surgery
outcomes was also provided. Studentized residuals and                  was found.
Cook's distances were used to examine whether studies
may be outliers and/or influential in the context of the
model. Studies with a studentized residual larger than the
100 x (1 - 0.05/(2 X k))th percentile of a standard normal
distribution were considered potential outliers (i.e., using a
Bonferroni correction with two-sided alpha = 0.05 for k
       Corresponding author:                                      56                                 Submission received: 23/06/2023
       Stefano Terzoni: stefano.terzoni@asst-santipaolocarlo.it                               End of Peer Review process: 28/07/2023
       Via Ovada 26, 20142 Milano, Italy                                                                       Accepted: 30/07/2023

                                                                           This work is licensed under a Creative Commons
                                                                           Attribution-NonCommercial-NoDerivatives 4.0 nternational
       ISSN: 2785-7263                                                                                                    DOI: 10.54103/dn/20383




                                                      Identification of studies via databases and registers

                                         Records identified from                            Records removed before
                                         databases (n=238):                                 screening:
                        Identification




                                         Pubmed n=44                                             Duplicate records removed
                                                                                                 (n = 73)
                                         CINAHL n=34
                                                                                                 Records marked as ineligible
                                         Web of Science n=30                                     by automation tools (n = 0 )




                                         Records screened                                   Records excluded**

                                         (n = 135)                                          (n = 130)



                                         Reports sought for retrieval                       Reports not retrieved
                        Screening




                                         (n = 5)                                            (n = 5)



                                         Reports assessed for eligibility

                                         (n = 5)
                                                                                            Reports excluded: 0




                                         Studies included in review
                        Included




                                         (n = 5)

                                         Reports of included studies


                                                     Figure 1: PRISMA flow diagram of literature search

Characteristics and results of preoperative feedback                              and therefore the relevance of any information retrievable
                                                                                  in the papers, we report a qualitative discussion of all
Table 1 summarizes the characteristics of the studies and                         papers prior to performing the metanalysis.
the criteria suggested by the authors for preoperative BFB.
The total number of subjects was 406 (206 in the BFB                                      Burgio and colleagues [10] enroled 125 men
group, 200 undergoing PFMT alone). Considerable clinical                          undergoing radical prostatectomy, stratified according to
discrepancies were found between the papers in terms                              tumor differentiation (Stage T2a and T2b). Bladder diaries,
biofeedback methods (e.g. electromyographic vs                                    severe/continual leakage, daily pad count and
barometric), control groups (e.g. pelvic floor exercises vs                       Incontinence Impact Questionnaire were used as measures
written instruction only) and follow-up criteria.                                 of outcome. The proportion with several/ continual
Considering the small overall number of available studies
      Corresponding author:                                                 57                                   Submission received: 23/06/2023
      Stefano Terzoni: stefano.terzoni@asst-santipaolocarlo.it                                            End of Peer Review process: 28/07/2023
      Via Ovada 26, 20142 Milano, Italy                                                                                    Accepted: 30/07/2023

                                                                                       This work is licensed under a Creative Commons
                                                                                       Attribution-NonCommercial-NoDerivatives 4.0 nternational
        ISSN: 2785-7263                                                                                                      DOI: 10.54103/dn/20383




leakage at 6th month was statistically significant (5.9%
group vs 19.6% group, p=.04.)

                                    Interventi
                                                    Control
                                    on group                                                                                                      Power
          Article      Design                       Group                    Intervention details                       Comparison
                                       size                                                                                                      analysis
                                                     size

                                                                                                                    Written instruction
          Bales,                                                  45 min BFB 2 to 4 weeks before surgery,
                         RCT            47             50                                                           on postoperative                 No
           2000                                                   5-10”, 10 to 15 repetitions.
                                                                                                                          PFMT
                                                                  1 session of BFB with 2 to 10”
                                                                  contraction and 2 to 10” relaxation of                Postoperative
         Burgio,                                                  pelvic muscles + written instructions on             instructions to
                         RCT            50             46                                                                                            Yes
          2006                                                    45 exercises (3 groups of 15) with 10”            interrupt the urinary
                                                                  contractions in various positions and                     flow
                                                                  daily practice.
                                                                  3 weekly sessions of BFB + transversus
         Collado                                                                                                    Verbal instructions
                                                                  abdominis activation in abdominal
          Serra,         RCT            35             43                                                             about Kegel’s                  No
                                                                  hypopressive technique + daily PFMT at
           2013                                                                                                    exercises afte surgery
                                                                  home
                                                                  2 sessions of electromyographic BFB
         De Lira,                                                 guided by a physiotherapist +                        Usual care (no
                         RCT            16             15                                                                                            No
          2019                                                    instructions on how to continue PFMT                 prehabilitation)
                                                                  postoperatively
                                                                  10 maximum force contractions of 3” +
                                                                  3 maximum endurance contractions of                   7 days of
         Dijkstra,
                         RCT            58             45         30” + 1 Valsalva + 1 min rest. Toilet            postoperative PFMT                No
           2013
                                                                  training, abdominal breathing, muscle                   alone
                                                                  relaxation exercises.
                        Quasi
                                                                   PFMT + BFB two weeks before surgery,
        Lilli, 2006    experim          45             45                                                               PFMT alone                   No
                                                                        continued postoperatively
                         ental
                        Quasi
          Perez,                                                    Barometric BFB: 10 sessions, 7+6 min
                       experim          20             32                                                               No treatment                 No
           2018                                                          each (unspecified timing)
                         ental
                                                                  1 day before surgery: 3 sessions/day of
        Tienforti,                                                BFB, 10 minutes, 5” contraction + 5”
                         RCT            16            116                                                                No PFMT                     No
          2012                                                    relaxation, supine, repeated
                                                                  postoperatively after catheter removal.


                                                            Table 1: Characteristics of the studies

Another RCT [12] enrolled 32 patients undergoing open                               recovery rates in the two groups at 6 month follow up,
retropubic RP and found statistically significant differences                       since incidence of urinary continence was 94% vs 96% (p=
at 1 month (p=.02), 3 month (p=.01) and 6 month follow                              .59)
up (p=.002). In intervention group continence had been
achived by 6,8 and ten patients vs no patients, one patient                         Dijkstra-Eshuis and colleagues [24] enroled 122 patients
and one patient in control group (p=.02; p=.01; p=.002).                            undergoing laparoscopy-assisted radical prostatectomy
                                                                                    (LARP) in a randomized clinical trial (RCT). All patients
Bales and and colleagues (Bales at al., 2000) enroled 100                           were assessed preoperatively by a physiotherapist. The
men undergoing radical retropubic prostatectomy (RRP)                               intervention consisted of weekly 30-minutes sessions of
and found no statistically significant differences between                          PFMT for 4 weeks, with additional BFB according to a

       Corresponding author:                                                  58                                    Submission received: 23/06/2023
       Stefano Terzoni: stefano.terzoni@asst-santipaolocarlo.it                                              End of Peer Review process: 28/07/2023
       Via Ovada 26, 20142 Milano, Italy                                                                                      Accepted: 30/07/2023

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                                                                                          Attribution-NonCommercial-NoDerivatives 4.0 nternational
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standardized protocol (no details provided) for improving              Quantitative synthesis
endurance, muscular relaxation, and coordination with
abdominal breathing. The patients were thought to                      Continence recovery – 3 months after surgery
perform the exercises in different positions (not specified)
                                                                       Three studies were included. The observed log odds ratios
and to integrate them into daily activities. Control patients
                                                                       ranged from 0.8591 to 2.7081, with most estimates being
received written PFMT instruction after catheter removal.
                                                                       positive (100%). The estimated average log odds ratio was
The authors performed interim analysis on 122 patients, as
                                                                       1.0914 (95% CI[0.5230-1.6598]) and the average outcome
224 would have been required to achieve 80% statistical
                                                                       differed significantly from zero (z = 3.7635, p = 0.0002).
power, but the study was closed in advance due to the lack
                                                                       There was no significant amount of heterogeneity in the
of clinically relevant results: the treatment group had no
                                                                       true outcomes (Q[2] = 2.2295, p = 0.3280, tau² = 0.0000,
advantages in terms of continence after 6 weeks, 3
                                                                       I² = 0.0017%). The 95% prediction interval for the true
months, 6 months, 9 months, and 12 months (p>.05 for
                                                                       outcomes was [0.5230- 1.6599]; therefore the true
all comparisons).
                                                                       outcomes of the studies are generally in the same direction
         Collado et al. [11] analyzed data from 179 patients           as the estimated average outcome. None of the studies had
and found statistically significant differences in continence          studentized residuals larger than ± 2.3940, suggesting the
improvement, assessed with the International Consultation              absence of outliers. According to the Cook's distances,
on Incontinence Questionnaire – Short Form (ICIQ-UI                    none of the studies could be considered overly influential.
SF) at 6 weeks, 3 months, 6 months and one year after                  The rank correlation test indicated no funnel plot
surgery (p=.03, .002, .009, and .03 respectively).                     asymmetry (p = 0.1804). Figure 2 shows the forest plot
                                                                       summarizing       these    findings,   after    exponential
The study by Perez et al. [25] was excluded because it did             transformation to obtain odds ratios for clearer
not report follow-up timings; two other RCTs (26,27) was               understanding of the effect size.
also excluded because the treatment programme included
both pre- and postoperative BFB. At the end of the
selection process, the only studies that could be included
                                                                       Continence recovery – 6 months after surgery
in the metanalyis were those comparing preoperative BFB
with instructions on how to perform PFMT. Some studies                 Three studies were included. The observed log odds ratios
had multiple follow-up times, but most included                        ranged from 0.6329 to 3.2189, with most estimates being
assessment at three and six months after surgery; we chose             positive (100%). The estimated average log odds ratio was
these timings for our analyses. The only exception was the             1.5440 (95% CI[0.2513-2.8367]) and the average outcome
study by Dijkstra-Eshuis [24] in which the number of                   differed significantly from zero (z = 2.3409, p = 0.0192).
months at which the authors conducted their the interim                The Q-test for heterogeneity was not significant, but some
analysis was not specified. This study was not included in             heterogeneity may still be present in the true outcomes
the quantitative synthesis, being the only one with PFMT               (Q[2] = 5.7269, p = 0.0571, tau² = 0.8304, I² =
as controls.                                                           66.6143%). The 95% prediction interval for the true
                                                                       outcomes was [-0.6608-3.7487]; therefore, although the
At the end of study selection, three papers showed
                                                                       average outcome is estimated to be positive, in some
comparable clinical characteristics [28–30]. Two of them
                                                                       studies the true outcome may not. None of the studies had
suggested statistically significant improvement of
                                                                       studentized residuals larger than ± 2.3940, indicating the
continence with BFB [28,29] even though one reported
                                                                       absence of outliers in this model. According to the Cook's
enormous expected variability in the population [28]. A
                                                                       distances, none of the studies could be considered overly
third study [30] did not find a statistically significant
                                                                       influential. The rank correlation test did not indicate
advantage attributable to BFB; this conflict among the
                                                                       funnel plot asimmetry (p = 0.3333). Figure 3 shows the
papers suggested to proceed with a metanalysis.
                                                                       forest plot summarizing these findings, after exponential

       Corresponding author:                                      59                                  Submission received: 23/06/2023
       Stefano Terzoni: stefano.terzoni@asst-santipaolocarlo.it                                End of Peer Review process: 28/07/2023
       Via Ovada 26, 20142 Milano, Italy                                                                        Accepted: 30/07/2023

                                                                            This work is licensed under a Creative Commons
                                                                            Attribution-NonCommercial-NoDerivatives 4.0 nternational
       ISSN: 2785-7263                                                                                                  DOI: 10.54103/dn/20383




transformation to obtain odds                 ratios    for      clearer
understanding of the effect size.




                                                 Figure 2: Continence recovery 3 months after surgery




                                                 Figure 3: Continence recovery 6 months after surgery


DISCUSSION
Regarding implications for practice, since BFB cannot be                        progressively more demanding exercises, for a total of 45
separated from PFMT it is necessary to establish precise                        different tasks. These indication complies with the
criteria for preoperative exercises to be performed during                      physiology of muscular training, and agrees with studies by
BFB. Recommendation for practice can be cautiously                              other authors [34] regarding pelvic floor muscle training.
based on the studies by Burgio et al. (2006) and Collado et                     The only suggestion that should be discouraged regards
al. (2013), which had the largest effect size in our meta-                      stopping urine flow as suggested by Burgio et al., since it
analysis among those favorable to BFB (figure 2) and                            increases the post-void residual volume and translates into
provided indications on the timing and criteria of                              less efficient micturition as highlighted by recent literature
prehabilitation. The authors suggested a complete set of                        [35].

      Corresponding author:                                                60                                  Submission received: 23/06/2023
      Stefano Terzoni: stefano.terzoni@asst-santipaolocarlo.it                                          End of Peer Review process: 28/07/2023
      Via Ovada 26, 20142 Milano, Italy                                                                                  Accepted: 30/07/2023

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                                                                                     Attribution-NonCommercial-NoDerivatives 4.0 nternational
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Some authors [12] recommended patient relaxation during                prehabilitation can be managed by several categories of
pelvic contraction, which is paramount for muscular                    healthcare professionals (i.e., nurse, physiotherapists) in
performance, as suggested by the literature [36] to avoid              many countries worldwide; therefore, this information will
apnoea during training and subsequent increase in IAB.                 be useful to implement evidence-base programs based on
Dijkstra-Eshuis and colleagues [24] included the Valsalva              biofeedback.
manouvre in their preoperative program, but in our
opinion this cannot become a universal recommendation:
aged patients, such as many of those undergoing                        REFERENCES
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       Corresponding author:                                      61                                 Submission received: 23/06/2023
       Stefano Terzoni: stefano.terzoni@asst-santipaolocarlo.it                               End of Peer Review process: 28/07/2023
       Via Ovada 26, 20142 Milano, Italy                                                                       Accepted: 30/07/2023

                                                                           This work is licensed under a Creative Commons
                                                                           Attribution-NonCommercial-NoDerivatives 4.0 nternational
       ISSN: 2785-7263                                                                                       DOI: 10.54103/dn/20383




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      Stefano Terzoni: stefano.terzoni@asst-santipaolocarlo.it                               End of Peer Review process: 28/07/2023
      Via Ovada 26, 20142 Milano, Italy                                                                       Accepted: 30/07/2023

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      Corresponding author:                                      63                                 Submission received: 23/06/2023
      Stefano Terzoni: stefano.terzoni@asst-santipaolocarlo.it                               End of Peer Review process: 28/07/2023
      Via Ovada 26, 20142 Milano, Italy                                                                       Accepted: 30/07/2023

                                                                          This work is licensed under a Creative Commons
                                                                          Attribution-NonCommercial-NoDerivatives 4.0 nternational
