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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injuries, Lower Urinary Tract Symptoms, Dysuria, Incontinence

Intervention / Treatment
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* Device: Electrical pudendal nerve stimulation
* Device: Transvaginal electrical stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical pudendal nerve stimulation<br>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<br>* 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.<br>|
| Active Comparator: Transvaginal electrical stimulation<br>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<br>* A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A questionaire to evaluate the Qol |  | 1.5 years | 
| Residual urine volume |  | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pudendal nerve modulation, transanal/transvaginal electrical stimulation