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

S

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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