THE CATHETER, "MORE THAN JUST A VIEWER". PFMT WITH INDWELLING CATHETER FOR POST-PROSTATECTOMY INCONTINENCE, A RANDOMIZED CONTROLLED TRIAL

Filocamo M1, Alladio F1, Griffone F2, Moiso A1, Mondino P1, Andretta E3, Rossi R1, Rosso D4, Coppola P5

Research Type

Clinical

Abstract Category

Male Stress Urinary Incontinence (Post Prostatectomy Incontinence)

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Abstract 288
Male Stress Urinary Incontinence
Scientific Podium Short Oral Session 17
Thursday 5th September 2019
10:45 - 10:52
Hall G1
Clinical Trial Incontinence Rehabilitation Stress Urinary Incontinence Male
1.Urology Department, SS Annunziata Hospital, ASLCN1, Savigliano (CN), Italy, 2.DPSIA ASLCN1 Cuneo, 3.Urology Department ULSS 3, Dolo (VE), Italy, 4.Urology Department SS Annunziata Hospital, ASLCN1, Savigliano (CN), Italy, 5.Urology Department SS Annunziata Hospital, ASL CN1, Savigliano (CN), Italy
Presenter
M

Maria Teresa Filocamo

Links

Abstract

Hypothesis / aims of study
Radical prostatectomy (RP) is the most common treatment for patients with localized prostate cancer (LPC). Urinary incontinence (UI) is a significant bothersome sequela after RP that may worsen patient's quality of life. Pelvic floor muscle training (PFMT) is the main conservative treatment for men experiencing post-prostatectomy UI; However, timing of beginning PFMT  is still unclear. We hypothesized that indwelling catheter could facilitate awareness of pelvic muscles, for this reason trough this original novel prospective, randomized, controlled trial we evaluated the efficacy of very early training of the pelvic floor muscle in post-operative period with indwelling catheter in patients underwent open-RP.
Study design, materials and methods
From May 2016 and May 2018 we prospective enrolled 39 patients affected of localized PC and underwent to open RP performed by one surgeon, inclusion criteria: PSA <10, Gleason score </= 7, no history of neurological or psychiatric disorders. Exclusion criteria: previous history of overactive bladder or urinary incontinence.
Patients were randomized in two groups: 20 patients (Group A) started a guided PFMT, performed by a specialized nurse, in third post-operative day with indwelling catheter. Patients were invited to training daily tightening the catheter with pelvic muscles, and to continue to training the same muscles after catheter removal. 
The others 19 patients (group B) started conventional guided PFMT alone ten days after surgery when removed catheter. 
All patients (Group A and Group B) had a meeting with specialized nurse twice a week for the first 3 months and then if necessary.
All patients underwent bladder diary, completed ICS male questionnaire and 24 hour pad test at 1-3-6-9 and 12 months after surgery. Primary outcome was completely continence defined as no use of pads and negative 24 hour pad test (< 3 gr). Secondary outcome was quality of life measured with ICS male questionnaire total score. Fisher’s exact test was used to compare the proportion of patients in the two groups who were continent at 1, 3, 6, 9 and 12 months. One‐way Anova test was used to compare ICS male total score between the two groups.
Results
4 patients (2 in group A and 2 in group B) were removed from the study because of post-operative complications (1 for post-operative bleeding with necessity of transfusion, 1 for anostomotic dehiscence, 2 for post-operative anostomotic stenosis).
In group A (18 patients) 4 patients (22%) were completely continents at 1 month,  11 patients (61%) at 3 months,  15 (83%) at 6 months and 9 months, 16 (89%) at 12 months respectively. 
In Group B (17 patients), 2 (11%) patients were completely continents at 1 month, 4 (23%) at 3 months, 7 (41%) at 6 months, 8 (47%) at 9 months and  14 (82%) at 12 months. The difference between the two groups was statistical relevant at 3, 6 and 9 months (p<0.05), was not statistical significant at 1 and 12 months.
Mean ICS total score was for group A: 25 at one month, 15.41 at 3 months, 13.58 at 6 months, 13.05 at 9 months and 12.09 at 12 months respectively. For group B was 28.57 at one month, 19.92 at 3 months, 16.57 at 6 months, 14.75 at 9 months and 14 at 12 months respectively with a relevant statistical difference between the two groups at 3, 6, 9 and 12 months (p<0.05).
Interpretation of results
PFMT is a well knowing effective conservative approach in patients in post-radical prostatectomy period to aim and speed up the recovery of urinary continence. Until today many trials have investigated timing of the beginning of rehabilitation, e.g. pre surgery or post-surgery. At the best of our knowledge this is the first trial that investigate the role of indwelling catheter during PFMT. 
We thought that catheter in this case could facilitate the awareness of the pelvic floor muscles as well as the physiotherapist task's, to whom it is sufficient to ask the patients to tighten the catheter to obtain the desired contraction.  
The memory of the right contraction is maintained over time if properly trained.
Concluding message
A very early PFMT with indwelling catheter is safe and more effective than conventional post-operative PFMT alone without catheter to faster improve continence status after open radical prostatectomy.
Figure 1
Figure 2
References
  1. Post-prostatectomy incontinence and pelvic floor muscle training: a defining problem. Penson DF. Eur Urol. 2013 Nov;64(5):773-5
  2. Effectiveness of preoperative pelvic floor muscle training for urinary incontinence after radical prostatectomy: a meta-analysis. Wang W, Huang QM, Liu FP, Mao QQ. BMC Urol. 2014 Dec 16;14:99
  3. Pre-Operative Pelvic Floor Muscle Training--A Review. Nahon I, Martin M, Adams R. Urol Nurs. 2014 Sep-Oct;34 (5):230-7
Disclosures
<span class="text-strong">Funding</span> none <span class="text-strong">Clinical Trial</span> Yes <span class="text-strong">Public Registry</span> No <span class="text-strong">RCT</span> Yes <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> Comitato Etico Interaziendale dell’AO S. Croce e Carle, Cuneo (Italy) <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes