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

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

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

Study Overview

• Status: Unknown
• Conditions: Neurogenic Urinary Bladder, Spastic
• Intervention / Treatment: Procedure: urostim bilateral; Procedure: urostim unilateral

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • CHU Caen Normandie
    • Contact: Joffrey Drigny, MD MSC; Phone Number: +33231064533; Email: drigny-j@chu-caen.fr
    • Contact: Alexis Ruet, MD MSC; Phone Number: +33231064721; Email: ruet-a@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bilateral; 25 patients with an overactive bladder	Procedure: urostim bilateral; Treatment by bilateral neurostimulation of the tibial nerve
Active Comparator: unilateral; 25 patients with an overactive bladder	Procedure: urostim unilateral; Treatment by unilateral neurostimulation of the tibial nerve

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2019
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urinary Bladder, Neurogenic
• Other Study ID Numbers: UROSTIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No