Comparison of the Efficacy of Perineal and Anal Electrical Stimulation in Patients with Urinary Incontinence After Radical Prostatectomy

Sponsor
Pamukkale University
Study ID
NCT06669468
Status
Not Yet Recruiting

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Conditions

  • Prostatectomy
  • Urinary Incontinence

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • PFME — OTHER
    All 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
    Anal ES was applied 3 days a week, 20 minutes a day, for a total of 24 sessions for 8 weeks.
  • PFME + Perineal ES — OTHER
    Perineal ES was applied 3 days a week, 20 minutes a day, for a total of 24 sessions for 8 weeks.

Study Details

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.

Key Dates

First listed
Nov 1, 2024
Start date
Nov 30, 2024
Status verified
Oct 2024
Primary completion
Jan 1, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
93 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Group 1: PFME
    The patients were instructed to do as an home exercise program in first 2 weeks, 5 s contraction and 10 s relaxation, including two sets of 5 repetition daily, in following 2 weeks 10 s contraction and 20 s relaxation, including two sets of 10 repetition daily, and after 4 weeks, 10 s contraction and 20 s relaxation including three sets of 10 repetition daily in three different position (lying, sitting, and standing). So in the first 2 weeks 30 contractions daily, in following 2 weeks 60 contractions daily and upward 4th weeks, 90 contractions daily with progressively increasing intensity was done. All 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.
  • Experimental: Group 2: PFME + Anal ES
    Anal ES was applied in the lithotomy position by means of a combined electrotherapy (stimulation) device with anal electrodes. Anal ES was applied 3 days a week, 20 minutes a day, for a total of 24 sessions for 8 weeks. Stimulation parameters were 50 Hz frequency, 5-10 s work-rest cycle and 300 µs pulse amplitude. Symmetrical biphasic pulse wave was given in the range of 1-100 mA (according to the patient's discomfort level feedback). In this procedure, it was applied with an anal probe placed in the anal region. Patients did not perform voluntary contractions during ES. Anal probes were used separately for each patient. Anal ES sessions were performed by an investigator participating in the study. Men who missed any treatment session for the stimulation group were excluded from the study.
  • Experimental: Group 3: PFME + Perineal ES
    Perineal ES was applied in the lithotomy position by means of a combined electrotherapy (stimulation) device with surface electrodes. Anal ES was applied 3 days a week, 20 minutes a day, for a total of 24 sessions for 8 weeks. Stimulation parameters were 50 Hz frequency, 5-10 s work-rest cycle and 300 µs pulse amplitude. Symmetrical biphasic pulse wave was given in the range of 1-100 mA (according to the patient's discomfort level feedback). In this procedure, five surface electrodes with a diameter of 2 cm will be used, four electrodes symmetrically in the perianal region and one electrode in the leg (ground-neutral electrode). Patients will not perform voluntary contractions during ES. Surface electrodes will be used separately for each patient. Perineal ES sessions were performed by an investigator participating in the study. Men who missed any treatment session for the stimulation group were excluded from the study.

Primary Outcome Measure

Severity of incontinence [ Time Frame: 8 weeks ]

Central Contacts

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