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

NCT02554201 | Completed DMC

• 1 other identifier: ZYY201501
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pudendal nerve modulation; transanal/transvaginal electrical stimulation

Outcome Measures

Primary Outcomes (1)

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

  1.5 years

Secondary Outcomes (2)

• A questionaire to evaluate the Qol

  1.5 years

• Residual urine volume

  1.5 years

Study Arms (2)

Electrical pudendal nerve stimulation

EXPERIMENTAL

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

Transvaginal electrical stimulation

ACTIVE COMPARATOR

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

Interventions

Electrical pudendal nerve stimulation DEVICE

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.

Electrical pudendal nerve stimulation

Transvaginal electrical stimulation DEVICE

A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES

Transvaginal electrical stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead
• RenJi Hospital: collaborator

Study Sites (1)

Shanghai research institute of acupuncture and meridian

Shanghai, 200030, China

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Lower Urinary Tract Symptoms; Dysuria

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Siyou Wang, Master

  Shanghai research institute of acupuncture and meridian

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 18, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

CN (1)