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

Not Applicable

Completed

• Conditions: Dysuria; Incontinence; Lower Urinary Tract Symptoms; Spinal Cord Injuries
• Interventions: Device: Transvaginal electrical stimulation; Device: Electrical pudendal nerve stimulation

• Registration Number: NCT02554201
• Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

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 Description

Not available

Study Timeline

• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Study Start: 2015-10
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transvaginal electrical stimulation	Transvaginal electrical stimulation	At a current intensity of \< 60 mA (as high as possible to get a contraction) and frequencies of 15 Hz and 85 Hz (alternate 3-min periods of stimulation); 30 min three times a week for a total of four weeks.
Electrical pudendal nerve stimulation	Electrical pudendal nerve stimulation	Electrical pudendal nerve stimulation At a frequency of 2.0 Hz and a moderate intensity (25\~35 mA); 60 minutes three times a week for a total of four weeks

Primary Outcome Measures

Name	Time	Method
A questionaire to measure the severity of lower urinary tract symptoms (male/female)	1.5 years

Secondary Outcome Measures

Name	Time	Method
A questionaire to evaluate the Qol	1.5 years
Residual urine volume	1.5 years

Trial Locations

Locations (1)

Shanghai research institute of acupuncture and meridian; 🇨🇳 Shanghai, China