Bilateral vs. Unilateral Stimulation in Neurological Bladder Disroders (UROSTIM)
Primary Purpose
Neurogenic Urinary Bladder, Spastic
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
urostim bilateral
urostim unilateral
Sponsored by
About this trial
This is an interventional treatment trial for Neurogenic Urinary Bladder, Spastic
Eligibility Criteria
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:
-
Sites / Locations
- CHU Caen NormandieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
bilateral
unilateral
Arm Description
25 patients with an overactive bladder
25 patients with an overactive bladder
Outcomes
Primary Outcome Measures
Urinary symptom profile score (USP score)
auto quastionnaire between 0 and 39 points The higher the score the higher the urinary symptoms
Secondary Outcome Measures
mictional calendar
records the number of mictions per day and the number of urinary leaks per day over 48 hours
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)
Full Information
NCT ID
NCT04225143
First Posted
December 12, 2019
Last Updated
January 8, 2020
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT04225143
Brief Title
Bilateral vs. Unilateral Stimulation in Neurological Bladder Disroders
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Urinary Bladder, Spastic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bilateral
Arm Type
Experimental
Arm Description
25 patients with an overactive bladder
Arm Title
unilateral
Arm Type
Active Comparator
Arm Description
25 patients with an overactive bladder
Intervention Type
Procedure
Intervention Name(s)
urostim bilateral
Intervention Description
Treatment by bilateral neurostimulation of the tibial nerve
Intervention Type
Procedure
Intervention Name(s)
urostim unilateral
Intervention Description
Treatment by unilateral neurostimulation of the tibial nerve
Primary Outcome Measure Information:
Title
Urinary symptom profile score (USP score)
Description
auto quastionnaire between 0 and 39 points The higher the score the higher the urinary symptoms
Time Frame
3 months
Secondary Outcome Measure Information:
Title
mictional calendar
Description
records the number of mictions per day and the number of urinary leaks per day over 48 hours
Time Frame
3 months
Title
Patient global impression of improvement (PGI-I)
Description
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)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène LARDREAU
Phone
02 31 06 47 21
Email
lardreau-h@chu-caen.fr
Facility Information:
Facility Name
CHU Caen Normandie
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joffrey Drigny, MD MSC
Phone
+33231064533
Email
drigny-j@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Alexis Ruet, MD MSC
Phone
+33231064721
Email
ruet-a@chu-caen.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bilateral vs. Unilateral Stimulation in Neurological Bladder Disroders
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