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

July 27, 2017 updated by: Shanghai Institute of Acupuncture, Moxibustion and Meridian
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200030
        • Shanghai Research Institute of Acupuncture and Meridian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: Electrical pudendal nerve stimulation
Four sacral points are selected. The two upper points are located about 1 cm bilateral to the sacrococcygeal joint. Needles of 0.40 Х 100 mm are inserted perpendicularly to the upper points to a depth of 80 to 90 mm to produce a sensation referred to the urethra or the anus. The two lower points are about 1 cm bilateral to the tip of the coccyx. Needles of 0.40 Х 100 or 125 mm are inserted obliquely to the lower points towards the ischiorectal fossa to a depth of 90 to 110 mm to produce a sensation referred to the urethra. After the sensation referred to the above regions is produced, each of two pairs of electrodes from a G6805-2 Multi-Purpose Health Device is connected with the two ipsilaterally needles.
Active Comparator: 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.
Device: Transvaginal electrical stimulation
A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A questionaire to measure the severity of lower urinary tract symptoms (male/female)
Time Frame: 1.5 years
1.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
A questionaire to evaluate the Qol
Time Frame: 1.5 years
1.5 years
Residual urine volume
Time Frame: 1.5 years
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Collaborators

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 24, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Actual)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 27, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZYY201501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lower Urinary Tract Symptoms

Clinical Trials on Electrical pudendal nerve stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe