Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder

Study Overview
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Brief Summary
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The primary objective of this study is to compare the efficacy of unilateral and bilateral neuromodulation tests at 1 month.

Detailed Description
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The secondary objectives of this study are to compare the following elements between a group of patients undergoing unilater modulation tests (standard procedure) and a group of patients undergoing bilateral neuromodulation tests (experimental procedure) (at 1 month): Pollakiuria, pad use, urge incontinence, symptom severity, % of patients not eligible for an implant, debimetry, tolerance, complications, quality of life.

Official Title
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Prospective Randomized Trial Comparing Unilateral and Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Procedure: Unilateral electrode placement and testing
* Procedure: Bilateral electrode placement and testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available for 1 month of follow-up The patient understands and reads French The patient has symptoms of overactive bladder resistant to first-line treatments (physiotherapy, anticholinergics) The patient suffers from an overactive bladder confirmed by a urodynamic panel The patient suffers from an overactive bladder unassociated with bladder obstruction as confirmed by flowmetry The patient has primary (idiopathic) overactive bladder primary with normal urinalysis, abdominal and pelvic ultrasound, urine cytology + / - cystoscopy The patient has no bleeding disorders, or the disorder is properly controlled after treatment Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant, parturient, or breastfeeding Overactive bladder associated with bladder obstruction as determined by flowmetry Overactive bladder unconfirmed by urodynamic panel Overactive bladder secondary to another condition: vesical: urolithiasis, bladder polyp, interstitial cystitis pelivienne: tumor or inflammatory neurological: multiple sclerosis, brain tumor, epilepsy the patient has an uncorrectable bleeding disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unilateral testing<br>Following standard procedures, patients in this group will have unilateral testing for neuromodulation of the sacral nerves. Intervention: Unilateral electrode placement and testing | Procedure: Unilateral electrode placement and testing<br>* An electrode is placed near a sacral nerve with an anal motor response under general anesthesia. During and adjustment phase, the electode is connected to a test box which allows for adjustment of stimulation parameters. After pinpointing stimulation parameters, the external test box is replaced by an implanted device.<br>|
| Experimental: Bilateral testing<br>Patients in this group will have bilateral testing for neuromodulation of the sacral nerves. Intervention: Bilateral electrode placement and testing | Procedure: Bilateral electrode placement and testing<br>* Two electrodes are placed, one near each sacral nerve under general anesthesia. During an adjustment phase, the electodes are connected to a test box which allows for adjustment of stimulation parameters. This can result in the use of one or the other, or both electrodes, thus increasing the chances of success and the possibility that the patient is eligible for an implant. After pinpointing stimulation parameters, the external test box is replaced by an implanted device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | Success is defined as a >= 50% improvement in at least one of the following symtoms: pollakiuria, number of urge incontinence episodes with incontinence, number of urge incontinence episodes. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence/absence: 50% reduction in the number of daily mictions |  | 1 month | 
| presence/absence: 50% reduction in the number of pads/protections used per day |  | 1 month | 
| presence/absence: 50% reduction in the number of urge incontinence episodes per day |  | 1 month | 
| presence/absence: 50% reduction in the number of urge incontinence episodes with incontinence per day |  | 1 month | 
| Symptom severity as measured by the MHU score | MHU = Mesure Hanicap Urinaire | 1 month | 
| Yes/no: the patient was eligible for an implant |  | 1 month | 
| debimetry: flow rate per voiding |  | 1 month | 
| debimetry: urinary volume per voiding |  | 1 month | 
| Visual analog scale for pain at the implantation site |  | 1 month | 
| Visual analog scale for pain due to neuro stimulation (pain in legs or buttocks) |  | 1 month | 
| Presence/absence of infection of the implant or electrode |  | 1 month | 
| Change in quality of life: IQoL score |  | baseline to 1 month | 
| Change in quality of life: KHQ score |  | baseline to 1 month | 
| Change in quality of life: SF 36 score |  | baseline to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory overactive bladder, neuromodulation, sacral nerves