A PSM Analysis to Evaluate Electrical Pudendal Nerve Stimulation for PPI

Electrical Pudendal Nerve Stimulation Versus Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation for Post-Radical Prostatectomy Incontinence: A Propensity Score Matching Analysis

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence Following Surgical Procedure
• Intervention / Treatment: Procedure: electrical pudendal nerve stimulation; Procedure: 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 Type: Observational
• Enrollment (Actual): 389

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200030
    • Shanghai Research Institute of Acupuncture and Meridian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged between 18-80 with post-radical prostatectomy incontinence treated at 3 tertiary academic medical centers between 2012 and 2020 were retrieved.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Electrical Pudendal Nerve Stimulation Group; Electrical Pudendal Nerve Stimulation	Procedure: electrical pudendal nerve stimulation; The patient was positioned prone post-micturition. Long needles (0.40 Х 100 mm) were inserted perpendicularly, 1 cm bilateral to the sacrococcygeal joint, to a depth of 80-90 mm, eliciting sensations referred to the urethra or anus. The lower points, 1 cm bilateral to the coccyx tip, received oblique insertion of longer needles (0.40 Х 125 mm) toward the ischiorectal fossa (90-110 mm depth), inducing sensations precisely to the urethra. Connected to a G6805-2 Multi-Purpose Health Device, the ipsilateral needles created an electric loop, with the upper as anode and lower as cathode. Direct electrical stimulation (2.5 Hz, 25~35 mA) for 45 minutes targeted the pudendal nerve, thrice weekly for a minimum of 8 weeks. The treatment plan remains ongoing until the patient opts to discontinue voluntarily.
Pelvic Floor Muscle Training Group; Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation	Procedure: pelvic floor muscle training combined with transanal electrical stimulation; Electromyogram BF-assisted PFMT (using a nerve function reconstruction treatment system [AM1000B; Shenzhen Creative Industry Co. Ltd, China]) and following TES (using a neuromuscular stimulation therapy system (PHENIX USB 4, Electronic Concept Lignon Innovation, France)) at a current intensity of < 60 mA (as high as possible to get a PFM contraction) and frequencies of 15 Hz and 85 Hz (alternate 3-minute periods of stimulation) were performed by a specially trained therapist, 20 minutes each time, respectively (a total of 40 minutes), 3 times a week for a total of 8 weeks. The patients also conducted 30 maximal high-intensity PFM contractions for 2-6 seconds (with 2-6 seconds rest), 3 sessions every day at home for a total of 8 weeks. If the patient is willing, the treatment plan can continue until the patient voluntarily decides to stop.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Consultation on Incontinence Questionnaire-short form score (ICIQ-SF)	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.	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pad-counting Score	the number of urine pad consumption in 24 hours.The higher the score, the more severe the condition.	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).

Collaborators and Investigators

• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Collaborators: Shanghai Pudong Hospital of Traditional Chinese Medicine
• Investigators: Principal Investigator: Siyou Wang, Shanghai Research Institute of Acupuncture and Meridian

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: November 12, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence
• Other Study ID Numbers: PWRq2022-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If necessary, contact Dr. Siyou Wang to provide the original data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No