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

NCT06669468 | Not Yet Recruiting

• 1 other identifier: PamukkaleU.ftr-NYıldız-002
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatectomy; Urinary Incontinence

Keywords

Anal Electrical Stimulation; Perineal Electrical Stimulation; Radical Prostatectomy; İncontinence

Outcome Measures

Primary Outcomes (1)

• Severity of incontinence

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

  8 weeks

Secondary Outcomes (8)

• Incontinence episodes

  8 weeks

• Three-day Bladder Diary

  8 weeks

• Quality of Life - Incontinence Impact Questionnaire (IIQ-7)

  8 weeks

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

  6 weeks

• Level of Anxiety and Depression - Hospital Anxiety and Depression Scale (HAD)

  8 weeks

Study Arms (3)

Group 1: PFME

ACTIVE COMPARATOR

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.

Other: PFME

Group 2: PFME + Anal ES

EXPERIMENTAL

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.

Other: PFME + Anal ES

Group 3: PFME + Perineal ES

EXPERIMENTAL

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.

Other: PFME + Perineal ES

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.

Group 1: PFME

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.

Group 2: PFME + Anal ES

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.

Group 3: PFME + Perineal ES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

pentalenolactone F methyl ester

Condition Hierarchy (Ancestors)

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

Study Officials

• Necmettin YILDIZ Prof.

  Pamukkale University

  STUDY DIRECTOR

Central Study Contacts

Serhat ÖTKEN M.D. M.D.

CONTACT

+905412260861; serhatotkenn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: November 30, 2024
• Primary Completion: January 1, 2026
• Study Completion: February 28, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)