search
Back to results

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

Primary Purpose

Spinal Cord Injuries, Lower Urinary Tract Symptoms, Dysuria

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electrical pudendal nerve stimulation
Transvaginal electrical stimulation
Sponsored by
Shanghai Institute of Acupuncture, Moxibustion and Meridian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring pudendal nerve modulation, transanal/transvaginal electrical stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shanghai research institute of acupuncture and meridian

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electrical pudendal nerve stimulation

Transvaginal electrical stimulation

Arm 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

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.

Outcomes

Primary Outcome Measures

A questionaire to measure the severity of lower urinary tract symptoms (male/female)

Secondary Outcome Measures

A questionaire to evaluate the Qol
Residual urine volume

Full Information

First Posted
August 24, 2015
Last Updated
July 27, 2017
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Collaborators
RenJi Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02554201
Brief Title
Efficacy of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction
Official Title
Efficacy of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Collaborators
RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Lower Urinary Tract Symptoms, Dysuria, Incontinence
Keywords
pudendal nerve modulation, transanal/transvaginal electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical pudendal nerve stimulation
Arm Type
Experimental
Arm 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
Arm Title
Transvaginal electrical stimulation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Electrical pudendal nerve stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transvaginal electrical stimulation
Intervention Description
A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES
Primary Outcome Measure Information:
Title
A questionaire to measure the severity of lower urinary tract symptoms (male/female)
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
A questionaire to evaluate the Qol
Time Frame
1.5 years
Title
Residual urine volume
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siyou Wang, Master
Organizational Affiliation
Shanghai research institute of acupuncture and meridian
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai research institute of acupuncture and meridian
City
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs