Bilateral vs. Unilateral Stimulation in Neurological Bladder Disroders

Not Applicable

• Conditions: Neurogenic Urinary Bladder, Spastic
• Interventions: Procedure: urostim unilateral; Procedure: urostim bilateral

• Registration Number: NCT04225143
• Lead Sponsor: University Hospital, Caen

Brief Summary

This study evaluates the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.

Detailed Description

Urinary disorders are common in neurological diseases. The prognosis of neurological bladders is twofold. On the one hand, symptoms such as incontinence or retention affect quality of life and comfort. On the other hand, complications such as urinary tract infections or renal failure threaten health and even involve patients' vital prognosis. Several therapies are used to treat these urinary disorders including transcutaneous or percutaneous posterior tibial nerve stimulation (SNTP). SNTP is used in treating symptoms of bladder overactivity. This treatment is most often used unilaterally, but can be used bilaterally.

The aim of this study is to evaluate the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.

50 patients will be included, in two arms by randomization, one arm of 25 patients will be treated by unilateral stimuylation and the other arm of 25 patients will be trated by bilateral stimulation.

They will be evaluate at 3, 6 and 12 months by auto questionnaire and the effectivess of each therapy will be compared.

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-27
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2020-01-08
• Last Update Submitted: 2020-01-08
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13
• Primary Completion: 2020-10-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Individuals who received research information
• Individuals affiliated to a social security scheme
• Individuals over 18 years of age
• Individuals with non-serious neurological bladder hyperactivity

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
unilateral	urostim unilateral	25 patients with an overactive bladder
bilateral	urostim bilateral	25 patients with an overactive bladder

Primary Outcome Measures

Name	Time	Method
Urinary symptom profile score (USP score)	3 months	auto quastionnaire between 0 and 39 points The higher the score the higher the urinary symptoms

Secondary Outcome Measures

Name	Time	Method
mictional calendar	3 months	records the number of mictions per day and the number of urinary leaks per day over 48 hours
Patient global impression of improvement (PGI-I)	3 months	Questionnaire of quality of life improvement :The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better) to 7 (Very much worse)

Trial Locations

Locations (1)

CHU Caen Normandie; 🇫🇷 Caen, France