CompletedNot Applicable

Efficacy of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction

China30 participantsStarted 2015-10

Plain-language summary

The main goal to treat early NLUTS is to relieve lower urinary tract syndrome and prevent from late complications. The present study is to evaluate the efficacy of electrical pudendal nerve stimulation (EPNS) and transanal/transvaginal electrical stimulation (TES) in NLUTD.The study design consists of a non-randomized, parallel controlled trial. A total of 60 eligible patients will be involved and divided into EPNS or TES group according to their location of medical treatment. The primary endpoint is lower urinary tract syndromes (ICIQ-FLUTS/MLUTS). The second endpoint is assessment of daily life Qol (ICIQ-LUTSqol), and residual urine volume.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18+ years; * Diagnosed as NLUTD; * Incomplete spinal cord injury (SCI), including but not limited to conus medullaris syndrome, cauda equina syndrome, etc.; * Radical pelvic surgery: including but not limited to total hysterectomy etc.; * Informed consent signed. Exclusion Criteria: * Anatomical bladder outlet obstruction (e.g., prostate enlargement, tumors); * NLUTD induced by stroke, multiple sclerosis, HIV, diabetes mellitus, drug, and inflammation or tumor of central nervous system etc.; * Lower urinary tract infections; * Unwillingness to participate.

What they're measuring

A questionaire to measure the severity of lower urinary tract symptoms (male/female)

Timeframe: 1.5 years

Trial details

NCT IDNCT02554201

SponsorShanghai Institute of Acupuncture, Moxibustion and Meridian

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10

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