A PSM Analysis to Evaluate Electrical Pudendal Nerve Stimulation for PPI

NCT06130306 | Completed DMC

• 1 other identifier: PWRq2022-47
• Study Type: observational
• Target: 389
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence Following Surgical Procedure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Study Arms (2)

Electrical Pudendal Nerve Stimulation Group

Electrical Pudendal Nerve Stimulation

Procedure: electrical pudendal nerve stimulation

Pelvic Floor Muscle Training Group

Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation

Procedure: pelvic floor muscle training combined with transanal electrical stimulation

Interventions

electrical pudendal nerve stimulation PROCEDURE

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.

Electrical Pudendal Nerve Stimulation Group

pelvic floor muscle training combined with transanal electrical stimulation PROCEDURE

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.

Pelvic Floor Muscle Training Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead
• Shanghai Pudong Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Shanghai research institute of acupuncture and meridian

Shanghai, 200030, China

Location

Related Publications (1)

• Li T, Wang S, Chen Q, Lv T, Huang Z. Electrical pudendal nerve stimulation versus pelvic floor muscle training with transrectal electrical stimulation for post-radical prostatectomy incontinence: a cohort study. Sci Rep. 2025 Nov 24;15(1):41603. doi: 10.1038/s41598-025-25567-3.

  PMID: 41286037 DERIVED

Study Officials

• Siyou Wang

  Shanghai research institute of acupuncture and meridian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 14, 2023
• Study Start: December 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 13, 2025

Record last verified: 2023-08

Locations

CN (1)