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NCT Number: NCT06669468

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

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.

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Key information

Conditions

Prostatectomy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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.

Primary outcomes

  1. Severity of incontinence

    Time frame: 8 weeks

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

Secondary outcomes

  1. Incontinence episodes

    Time frame: 8 weeks

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

  2. Three-day Bladder Diary

    Time frame: 8 weeks

    It was used "frequency of voiding", "incontinence episodes", "nocturia", "number of pads" from data collected with a 3-day bladder diary.

  3. Quality of Life - Incontinence Impact Questionnaire (IIQ-7)

    Time frame: 8 weeks

    The IIQ-7 scale which has great validity in studies was used to assess the patient's QoL associated with incontinence problem

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

    Time frame: 6 weeks

    Sexual functions

  5. Level of Anxiety and Depression - Hospital Anxiety and Depression Scale (HAD)

    Time frame: 8 weeks

    Anxiety and Depression

  6. Treatment satisfaction - Likert scale (1-5 )

    Time frame: 8 weeks

    The patients evaluated the change of their urinary incontinence on a 5-point Likert scale (5, very satisfied; 4, satisfied; 3, equally satisfied and unsatisfied; 2, unsatisfied; 1, very unsatisfied)

  7. Treatment Success (Continence rate)

    Time frame: 8 weeks

    Patients with ≤8 gr in 24-hour pad test measurement will be considered "continent"

  8. Cure (Dry) and Improvement Rate

    Time frame: 8 weeks

    the absence of will be evaluated as "dryness"

Study contacts

Contact information is provided by the study sponsor or research team.

Serhat ÖTKEN M.D. M.D.

CONTACT

[email protected]

+905412260861

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Comparison of the Efficacy of Perineal and Anal Electrical Stimulation in Patients with Urinary Incontinence After Radical Prostatectomy. a Prospective Randomised Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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