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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554201
• Other study ID #: ZYY201501
• Status: Completed
• Phase: N/A
• First received: August 24, 2015
• Last updated: July 27, 2017
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Shanghai research institute of acupuncture and meridian	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian	RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A questionaire to measure the severity of lower urinary tract symptoms (male/female)		1.5 years
Secondary	A questionaire to evaluate the Qol		1.5 years
Secondary	Residual urine volume		1.5 years