Bilateral vs. Unilateral Stimulation in Neurological Bladder Disroders

Neurogenic Urinary Bladder, Spastic Clinical Trial

— UROSTIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04225143
• Other study ID #: UROSTIM
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2019
• Source: University Hospital, Caen
• Contact: Hélène LARDREAU
• Phone: 02 31 06 47 21
• Email: lardreau-h[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Neurogenic Urinary Bladder, Spastic
• Urinary Bladder, Neurogenic

Intervention

Procedure:
• urostim bilateral
Treatment by bilateral neurostimulation of the tibial nerve
• urostim unilateral
Treatment by unilateral neurostimulation of the tibial nerve

Locations

Country	Name	City	State
France	CHU Caen Normandie	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	mictional calendar	records the number of mictions per day and the number of urinary leaks per day over 48 hours	3 months
Secondary	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