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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-80
SponsorPamukkale University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • PFME

    Other intervention

    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 intervention

    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 intervention

    Perineal ES was applied 3 days a week, 20 minutes a day, for a total of 24 sessions for 8 weeks.

Treatment groups

93 Participants
are divided into 3 treatment groups
Group A: Group 1: PFMEActive comparator 1 intervention
Group B: Group 2: PFME + Anal ESExperimental treatment 1 intervention
Group C: Group 3: PFME + Perineal ESExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Severity of incontinence

The 24-hour pad test was carried out to evaluate urinary loss.

Time frame
8 weeks

Secondary outcomes

1

Incontinence episodes

Patients with a 50% or greater reduction in incontinence episodes were consider improvement

Time frame
8 weeks
2

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.

Time frame
8 weeks
3

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

Time frame
8 weeks
4

Level of sexual function - International Index of Erectile Function (IIEF)

Sexual functions

Time frame
6 weeks

Other outcomes

Sponsors and contacts

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