NCT04225143

Bilateral vs. Unilateral Stimulation in Neurological Bladder Disroders

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurogenic Urinary Bladder, Spastic

Interventions

Type	Name	Description
PROCEDURE	urostim bilateral	Treatment by bilateral neurostimulation of the tibial nerve
PROCEDURE	urostim unilateral	Treatment by unilateral neurostimulation of the tibial nerve

Timeline

• Start date: 2019-11-27
• Primary completion: 2020-10-31
• Completion: 2021-10-31
• First posted: 2020-01-13
• Last updated: 2020-01-13

Locations

1 site across 1 country: France