A PSM Analysis to Evaluate Electrical Pudendal Nerve Stimulation for PPI

Last updated: April 22, 2024
Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Incontinence

Enuresis

Treatment

electrical pudendal nerve stimulation

pelvic floor muscle training combined with transanal electrical stimulation

Clinical Study ID

NCT06130306
PWRq2022-47
  • Ages 18-80
  • Male

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • High pathological risk factors (e.g., lymph node metastasis, resection margininvolvement, 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

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: electrical pudendal nerve stimulation
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Shanghai research institute of acupuncture and meridian

    Shanghai, 200030
    China

    Active - Recruiting

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