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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-23

Study Completion Date

2018-01-23

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.

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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.

Conditions

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Urinary Bladder, Overactive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unilateral testing

Following standard procedures, patients in this group will have unilateral testing for neuromodulation of the sacral nerves.

Intervention: Unilateral electrode placement and testing

Group Type ACTIVE_COMPARATOR

Unilateral electrode placement and testing

Intervention Type PROCEDURE

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.

Bilateral testing

Patients in this group will have bilateral testing for neuromodulation of the sacral nerves.

Intervention: Bilateral electrode placement and testing

Group Type EXPERIMENTAL

Bilateral electrode placement and testing

Intervention Type PROCEDURE

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.

Interventions

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Unilateral electrode placement and testing

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.

Intervention Type PROCEDURE

Bilateral electrode placement and testing

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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No