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Completed

NCT Number: NCT02554201

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Dysuria Incontinence Lower Urinary Tract Symptoms Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Urological Manifestations Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai research institute of acupuncture and meridian

Shanghai, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Transvaginal electrical stimulation

Device

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

Primary outcomes

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

    Time frame: 1.5 years

Secondary outcomes

  1. A questionaire to evaluate the Qol

    Time frame: 1.5 years

  2. Residual urine volume

    Time frame: 1.5 years

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Collaborators

  • RenJi Hospital

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2015
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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