About this trial
Radical prostatectomy (RP) is a common procedure for the treatment of prostate cancer. However, postoperative urinary incontinence (UI) is an important reason for morbidity. UI negatively affects the quality of life in 30-50% of patients, especially in the early period (3 weeks to 6 months). However, it takes approximately 1 year to achieve continence (1).
Conservative treatment methods include pelvic floor muscle exercises (PFME) with or without biofeedback (BF), anal and perineal electrical stimulation (ES), magnetic stimulation (MS), compression (penile clamps), lifestyle changes and combinations of these methods (2).
ES artificially stimulates the pudendal nerve and its branches to cause direct and reflex responses of the urethral and periurethral striated muscles in women. ES also inhibits detrusor overactivity (3,4). There is conflicting evidence as to whether the addition of ES to treatment increases the efficacy of PFME alone in patients with UI after RP (Level of evidence:1b), (5). However, ES may benefit PFME for up to six months (Level of evidence: 2b), (5). Non-neurogenic male incontinence guidelines recommend PFME alone or in combination with BF and/or ES for men undergoing RP to accelerate improvement of UI (5).
Many studies have shown that anal ES alone (1,7,8) or in combination with PFME (4,9,10,11) is more effective than untreated (4,7,9,11) or placebo ES (8,12). There are only two randomised controlled trials in the literature evaluating the efficacy of perineal ES in patients with UI after RP (13,14). In the study by Yıldız et al. (13), the group receiving perineal ES and the control group receiving no treatment were compared in patients who developed UI after RP. The results showed that incontinence severity, incontinence episodes, quality of life and anxiety parameters improved significantly in the 8th week in the group receiving perineal ES compared to the control group. In the study by Pané-Alemany et al. (14), a group receiving perianal ES and a group receiving anal ES were compared in patients who developed UI after RP. In the study, it was shown that the efficacy of the two treatments was not statistically different.
Our study is the first prospective randomised controlled trial to evaluate the efficacy of perineal and anal ES added to PFME in patients with UI after RP. The aim of this study was to evaluate the efficacy of perineal ES and anal ES added to PFME on clinical parameters related to UI, quality of life and sexual functions, depression and anxiety. In addition, patients' preparation time for stimulation, treatment satisfaction and discomfort levels will be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-80 years old
Men with RP with incontinence over >50 g/24 h and no residual cancer after RP on pathological examination
Men within 1 month to 1 year after catheter removal
Willingness to complete and do the QoL scale.
Disqualifiers
UI history before RP.
History of conservative treatment after RP including ES.
Prolonged indwelling urethral catheterization (more than 15 days).
Previous urological surgery history.
Trial design
Parallel
Treatments tested in this trial
PFME
Other interventionAll patients were asked to mark the exercise at a daily home schedule. Patients who did not complete more than 20% of the list according to the daily home program were excluded from the study.
PFME + Anal ES
Other interventionAnal ES was applied 3 days a week, 20 minutes a day, for a total of 24 sessions for 8 weeks.
PFME + Perineal ES
Other interventionPerineal ES was applied 3 days a week, 20 minutes a day, for a total of 24 sessions for 8 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Severity of incontinence
The 24-hour pad test was carried out to evaluate urinary loss.
Secondary outcomes
Incontinence episodes
Patients with a 50% or greater reduction in incontinence episodes were consider improvement
Three-day Bladder Diary
It was used "frequency of voiding", "incontinence episodes", "nocturia", "number of pads" from data collected with a 3-day bladder diary.
Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
The IIQ-7 scale which has great validity in studies was used to assess the patient's QoL associated with incontinence problem
Level of sexual function - International Index of Erectile Function (IIEF)
Sexual functions
Sponsors and contacts
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