Neurogenic Urinary Bladder, Spastic
Conditions
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.
Interventions
PROCEDUREurostim bilateral
Treatment by bilateral neurostimulation of the tibial nerve
PROCEDUREurostim unilateral
Treatment by unilateral neurostimulation of the tibial nerve
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary symptom profile score (USP score) | 3 months | auto quastionnaire between 0 and 39 points The higher the score the higher the urinary symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mictional calendar | 3 months | 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) | 3 months | 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) |
Countries
France
Contacts
Primary ContactHélène LARDREAU
Outcome results
None listed