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

NACompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

October 23, 2012

Primary Completion Date

September 20, 2017

Study Completion Date

January 23, 2018

Conditions
Urinary Bladder, Overactive
Interventions
PROCEDURE

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.

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.

Trial Locations (6)

30029

CHU de Nîmes - Hôpital Universitaire Carémeau, Nîmes

31059

CHRU de Toulouse - Hôpital de Rangueil, Toulouse

34070

Clinique Beau Soleil, Montpellier

44093

CHU de Nantes - Hôtel Dieu, Nantes

75651

APHP - Groupe Hospitalier Pitié-Salpetrière, Paris

76031

CHU de Rouen - Hôpital Charles Nicolle, Rouen

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nīmes

OTHER

NCT01558856 - Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder | Biotech Hunter | Biotech Hunter