A PSM Analysis to Evaluate Electrical Pudendal Nerve Stimulation for PPI

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Status: Completed

Conditions: Urinary Incontinence Following Surgical Procedure

Treatments: Procedure: electrical pudendal nerve stimulation; Procedure: pelvic floor muscle training combined with transanal electrical stimulation

Study type: Observational

Funder types: Other

Identifiers

NCT06130306

PWRq2022-47

Details and patient eligibility

About

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.

Full 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.

Enrollment: 389 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

389 participants in 2 patient groups

Electrical Pudendal Nerve Stimulation Group

Description:

Electrical Pudendal Nerve Stimulation

Treatment:

Procedure: electrical pudendal nerve stimulation

Pelvic Floor Muscle Training Group

Description:

Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation

Treatment:

Procedure: pelvic floor muscle training combined with transanal electrical stimulation