A PSM Analysis to Evaluate Electrical Pudendal Nerve Stimulation for PPI

Recruiting

• Conditions: Urinary Incontinence Following Surgical Procedure
• Interventions: Procedure: pelvic floor muscle training combined with transanal electrical stimulation; Procedure: electrical pudendal nerve stimulation

• Registration Number: NCT06130306
• Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

Brief Summary

The goal of this propensity score matching study is to compare the posttreatment outcomes of post-radical prostatectomy Incontinence patients undergoing either electrical pudendal nerve stimulation or pelvic floor muscle training combined with transanal electrical stimulation.

Detailed Description

Prostate cancer is the predominant form of cancer in older males. Radical prostatectomy (RP) is the sole treatment that enhances both overall survival and cancer-specific survival.Urinary incontinence remains a major morbidity associated with this procedure, greatly affecting patient satisfaction following RP. Extant research underscores the efficacy of pelvic floor muscle training (PFMT) in improving the strength and function of specific pelvic floor muscles, causing hypertrophy of peri-urethral striated muscles, thereby increasing the external mechanical pressure on the urethra. Another promising physiotherapy for post-radical prostatectomy incontinence (PPI) is electrical pudendal nerve stimulation (EPNS). An increasing body of research focuses on comparing continence restoration outcomes between PFMT and various electrical stimulations. However, such studies encompass cases with multiple pathological characteristics, and the reported data might not be considered representative or applicable to other populations due to overlooked confounding factors or selection bias. Thus, the investigators intend to conduct a propensity score matching (PSM) study aiming to compare the posttreatment outcomes of patients undergoing either EPNS or PFMT combined with TES, while ensuring a well-balanced control for confounding factor.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-11-05
• Study First Submitted QC: 2023-11-12
• Study First Posted: 2023-11-14
• Study Start: 2023-12-01
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2024-11
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 180

Inclusion Criteria

• Onset of urinary incontinence at least 1 month post-RP
• Minimum two documented incontinence episodes per week in a 7-day bladder diary
• Pathological confirmation of no residual cancer post-RP

Exclusion Criteria

• High pathological risk factors (e.g., lymph node metastasis, resection margin involvement, bulky tumors)
• Preoperative incontinence
• Prior anticholinergic treatment
• Urinary tract infection or hematuria
• Postvoid residual volume exceeding 100 ml (determined by bladder ultrasound)
• Neurological disorders
• Urethral stricture

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pelvic Floor Muscle Training Group	pelvic floor muscle training combined with transanal electrical stimulation	Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation
Electrical Pudendal Nerve Stimulation Group	electrical pudendal nerve stimulation	Electrical Pudendal Nerve Stimulation

Primary Outcome Measures

Name	Time	Method
International Consultation on Incontinence Questionnaire-short form score (ICIQ-SF)	T0 (baseline); T1 (day after 24th treatment); T2 (day after 36th treatment); T3 (day after 48th treatment); T4 (day after 60th treatment); T5 (day after 72nd treatment).	The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) is a validated and widely used questionnaire to assess and measure the impact of urinary incontinence on an individual's quality of life. This part includes a set of simple questions related to urinary incontinence symptoms, which the individual answers. The questions address the type and frequency of incontinence episodes, as well as their impact on daily life. The higher the score, the more severe the condition.

Secondary Outcome Measures

Name	Time	Method
Pad-counting Score	T0 (baseline); T1 (day after 24th treatment); T2 (day after 36th treatment); T3 (day after 48th treatment); T4 (day after 60th treatment); T5 (day after 72nd treatment).	the number of urine pad consumption in 24 hours.The higher the score, the more severe the condition.

Trial Locations

Locations (1)

Shanghai research institute of acupuncture and meridian; 🇨🇳 Shanghai, China