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

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Status: Completed

Conditions: Lower Urinary Tract Symptoms; Spinal Cord Injuries; Incontinence; Dysuria

Treatments: Device: Transvaginal electrical stimulation; Device: Electrical pudendal nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02554201

ZYY201501

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Electrical pudendal nerve stimulation

Experimental group

Description:

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

Treatment:

Device: Electrical pudendal nerve stimulation

Transvaginal electrical stimulation

Active Comparator group

Description:

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.

Treatment:

Device: Transvaginal electrical stimulation