Clinical Trial: Efficacy of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Efficacy of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction
Brief 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.
Detailed Summary:
Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Current Primary Outcome: A questionaire to measure the severity of lower urinary tract symptoms (male/female) [ Time Frame: 1.5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- A questionaire to evaluate the Qol [ Time Frame: 1.5 years ]
- Residual urine volume [ Time Frame: 1.5 years ]
Original Secondary Outcome: Same as current
Information By: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Dates:
Date Received: August 24, 2015
Date Started: October 2015
Date Completion: December 2016
Last Updated: April 18, 2016
Last Verified: July 2015
