Clinical trial NCT06669468: Comparison of the Efficacy of Perineal and Anal Electrical Stimulation in Patients with Urinary Incontinence After Radical Prostatectomy
Official title: Comparison of the Efficacy of Perineal and Anal Electrical Stimulation in Patients with Urinary Incontinence After Radical Prostatectomy. a Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostatectomy
Urinary Incontinence
Keywords: Anal Electrical Stimulation
Perineal Electrical Stimulation
Radical Prostatectomy
İncontinence
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 93
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: The research will be conducted at Pamukkale University Physical Medicine and Rehabilitation (PMR) Department, Urogynecological Rehabilitation Unit between November 2024 and January 2025.

The study included 93 patients (described in detail in the statistics section) who accepted the treatment among the male patients who applied to Pamukkale University FTR Polyclinic with the complaint of UI after RP or who were referred to the Urogynecological Rehabilitation Unit by the Urology outpatient clinic and who met the inclusion criteria. Patients will be informed about the content, purpose and application of the study and their written consent will be obtained.

At the beginning of the study, age, height, weight, education level, occupation, marital status, previous operations, systemic diseases, alcohol, tea, coffee, coffee, cigarette use and medications will be questioned in patients who applied to Pamukkale University FTR Polyclinic or Urology Polyclinic with the complaint of UI after RP and referred to the Urogynecological Rehabilitation Unit. The type of UI (stress, urge, mixed, drip) will be determined in all patients participating in the study.

Patients will be advised to continue their medical treatments for reasons other than incontinence during the treatment period. No lifestyle modification recommendations regarding urinary function will be given during the treatment period and participants will be instructed not to change their habits during the 8-week period of the study.

Ninety-three male patients who meet the inclusion and exclusion criteria after RP will be randomly divided into three groups using a random number table. The first group will receive PFME, the second group will receive PFME + anal ES, and the third group will receive PFME + perineal ES.

Group 1: PFME Group 2: PFME + anal ES Group 3: PFME + perineal ES

Eligibility criteria: Inclusion Criteria:

* 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.
* Understanding procedures, benefits, and possible side effects.
* Being able to give written, informed consent.

Exclusion Criteria:

* UI history before RP.
* History of conservative treatment after RP including ES.
* Prolonged indwelling urethral catheterization (more than 15 days).
* Previous urological surgery history.
* Men receiving radiotherapy.
* Presence of urethral stricture and urinary tract infection.
* Heart failure, presence of a pacemaker, implanted defibrillator.
* Transurethral resection of the prostate due to benign prostatic hyperplasia.
* Use of drugs that may affect bladder function (antimuscarinic, duloxetine, tricyclic antidepressant, etc.).

Primary outcomes:
measure: Severity of incontinence
timeFrame: 8 weeks
Secondary outcomes:
measure: Incontinence episodes
timeFrame: 8 weeks
measure: Three-day Bladder Diary
timeFrame: 8 weeks
measure: Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
timeFrame: 8 weeks
measure: Level of sexual function - International Index of Erectile Function (IIEF)
timeFrame: 6 weeks
measure: Level of Anxiety and Depression - Hospital Anxiety and Depression Scale (HAD)
timeFrame: 8 weeks
measure: Treatment satisfaction - Likert scale (1-5 )
timeFrame: 8 weeks
measure: Treatment Success (Continence rate)
timeFrame: 8 weeks
measure: Cure (Dry) and Improvement Rate
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Necmettin YILDIZ Prof.
role: STUDY_DIRECTOR
References: