Bilateral vs. Unilateral Stimulation in Neurological Bladder Disroders

NCT ID: NCT04225143

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-27

Study Completion Date

2021-10-31

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.

Conditions

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Neurogenic Urinary Bladder, Spastic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bilateral

25 patients with an overactive bladder

Group Type EXPERIMENTAL

urostim bilateral

Intervention Type PROCEDURE

Treatment by bilateral neurostimulation of the tibial nerve

unilateral

25 patients with an overactive bladder

Group Type ACTIVE_COMPARATOR

urostim unilateral

Intervention Type PROCEDURE

Treatment by unilateral neurostimulation of the tibial nerve

Interventions

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urostim bilateral

Treatment by bilateral neurostimulation of the tibial nerve

Intervention Type PROCEDURE

urostim unilateral

Treatment by unilateral neurostimulation of the tibial nerve

Intervention Type PROCEDURE

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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Caen Normandie

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Hélène LARDREAU

Role: CONTACT

02 31 06 47 21

Facility Contacts

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Joffrey Drigny, MD MSC

Role: primary

+33231064533

Alexis Ruet, MD MSC

Role: backup

+33231064721

Other Identifiers

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UROSTIM

Identifier Type: -

Identifier Source: org_study_id

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