ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02554201
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : July 28, 2017
Sponsor:
Collaborator:
RenJi Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Lower Urinary Tract Symptoms Dysuria Incontinence Device: Electrical pudendal nerve stimulation Device: Transvaginal electrical stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction
Actual Study Start Date : October 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. A questionaire to measure the severity of lower urinary tract symptoms (male/female) [ Time Frame: 1.5 years ]

Secondary Outcome Measures :
  1. A questionaire to evaluate the Qol [ Time Frame: 1.5 years ]
  2. Residual urine volume [ Time Frame: 1.5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554201


Locations
China
Shanghai research institute of acupuncture and meridian
Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Institute of Acupuncture, Moxibustion and Meridian
RenJi Hospital
Investigators
Study Chair: Siyou Wang, Master Shanghai research institute of acupuncture and meridian

Responsible Party: Shanghai Institute of Acupuncture, Moxibustion and Meridian
ClinicalTrials.gov Identifier: NCT02554201     History of Changes
Other Study ID Numbers: ZYY201501
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Keywords provided by Shanghai Institute of Acupuncture, Moxibustion and Meridian:
pudendal nerve modulation
transanal/transvaginal electrical stimulation

Additional relevant MeSH terms:
Spinal Cord Injuries
Lower Urinary Tract Symptoms
Dysuria
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Urological Manifestations
Signs and Symptoms