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A PSM Analysis to Evaluate Electrical Pudendal Nerve Stimulation for PPI

NCT06130306 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 389

Last updated 2025-06-13

No results posted yet for this 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.

Conditions

  • Urinary Incontinence Following Surgical Procedure

Interventions

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.

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.

Sponsors & Collaborators

  • Shanghai Pudong Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Shanghai Institute of Acupuncture, Moxibustion and Meridian

    lead OTHER

Principal Investigators

  • Siyou Wang · Shanghai research institute of acupuncture and meridian

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-11-30
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06130306 on ClinicalTrials.gov