Bilateral vs. Unilateral Stimulation in Neurological Bladder Disroders (UROSTIM)

Caen University Hospital

Status: Unknown

Conditions: Neurogenic Urinary Bladder, Spastic

Treatments: Procedure: urostim bilateral; Procedure: urostim unilateral

Study type: Interventional

Funder types: Other

Identifiers

NCT04225143

UROSTIM

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

bilateral

Experimental group

Description:

25 patients with an overactive bladder

Treatment:

Procedure: urostim bilateral

unilateral

Active Comparator group

Description:

25 patients with an overactive bladder

Treatment:

Procedure: urostim unilateral