Bilateral vs. Unilateral Stimulation in Neurological Bladder Disroders

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

Detailed Description
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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.

Official Title
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Efficacité Clinique comparée de la Stimulation transcutanée du Nerf Tibial postérieur unilatérale vs bilatérale Pour Traiter Une hyperactivité vésicale Neurologique Non sévère : Essai Clinique randomisé

Conditions
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Neurogenic Urinary Bladder, Spastic

Intervention / Treatment
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* Procedure: urostim bilateral
* Procedure: urostim unilateral


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bilateral<br>25 patients with an overactive bladder | Procedure: urostim bilateral<br>* Treatment by bilateral neurostimulation of the tibial nerve<br>|
| Active Comparator: unilateral<br>25 patients with an overactive bladder | Procedure: urostim unilateral<br>* Treatment by unilateral neurostimulation of the tibial nerve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary symptom profile score (USP score) | auto quastionnaire between 0 and 39 points The higher the score the higher the urinary symptoms | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mictional calendar | records the number of mictions per day and the number of urinary leaks per day over 48 hours | 3 months | 
| Patient global impression of improvement (PGI-I) | 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) | 3 months |