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Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder

2014-07-23 21:11:38 | BioPortfolio

Summary

The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.

Description

The Medtronic InterStim device delivers stimulation therapy for the treatment of chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract through the sacral nerve or the pudendal nerve systems.

This trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. Symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. After the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Neurogenic Overactive Bladder

Intervention

InterStim Therapy

Location

Universitair Ziekenhuis Gent
Gent
Belgium
44627

Status

Recruiting

Source

Medtronic International Trading Sarl

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:38-0400

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Medical and Biotech [MESH] Definitions

Symptom of overactive detrusor muscle of the URINARY BLADDER that contracts with abnormally high frequency and urgency. Overactive bladder is characterized by the frequent feeling of needing to urinate during the day, during the night, or both. URINARY INCONTINENCE may or may not be present.

Dysfunction of the URINARY BLADDER due to disease of the central or peripheral nervous system pathways involved in the control of URINATION. This is often associated with SPINAL CORD DISEASES, but may also be caused by BRAIN DISEASES or PERIPHERAL NERVE DISEASES.

Symptoms of disorders of the lower urinary tract including frequency, NOCTURIA; urgency, incomplete voiding, and URINARY INCONTINENCE. They are often associated with OVERACTIVE BLADDER; URINARY INCOMPETENCE; and INTERSTITIAL CYSTITIS. Lower urinary tract symptoms in males were traditionally called PROSTATISM.

A HERNIA-like condition in which the weakened pelvic muscles cause the URINARY BLADDER to drop from its normal position. Fallen urinary bladder is more common in females with the bladder dropping into the VAGINA and less common in males with the bladder dropping into the SCROTUM.

Involuntary discharge of URINE as a result of physical activities that increase abdominal pressure on the URINARY BLADDER without detrusor contraction or overdistended bladder. The subtypes are classified by the degree of leakage, descent and opening of the bladder neck and URETHRA without bladder contraction, and sphincter deficiency.

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