Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder - Full Text View

Purpose

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

Condition	Intervention
Urinary Bladder, Overactive	Procedure: Unilateral electrode placement and testing Procedure: Bilateral electrode placement and testing

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Randomized Trial Comparing Unilateral and Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:

Success rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
"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.

Secondary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	October 2012
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Unilateral testing Following standard procedures, patients in this group will have unilateral testing for neuromodulation of the sacral nerves.	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.
Experimental: Bilateral testing Patients in this group will have bilateral testing for neuromodulation of the sacral nerves.	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.

Arms

Assigned Interventions

Active Comparator: Unilateral testing

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

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.

Experimental: Bilateral testing

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

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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558856

Contacts

Contact: Laurent Wagner, MD	+33.(0)4.66.68.33.00	laurent.wagner@chu-nimes.fr
Contact: Carey M Suehs, Ph D	+33.(0)4.66.68.67.88	carey.suehs@chu-nimes.fr

Locations

France
Clinique Beau Soleil	Not yet recruiting
Montpellier, France, 34070
Sub-Investigator: Antoine Faix, MD
CHU de Nîmes - Hôpital Universitaire Carémeau	Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Laurent Wagner, MD
Sub-Investigator: Stéphane Droupy, MD PhD
Sub-Investigator: Pierre Costa, MD PhD

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator:

Laurent Wagner, MD

Centre Hospitalier Universitaire de Nîmes

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:	NCT01558856 History of Changes
Other Study ID Numbers:	LOCAL/2011/LW-04, 2012-A00185-38
Study First Received:	March 18, 2012
Last Updated:	March 26, 2013
Health Authority:	France: L’Agence nationale de sécurité du médicament et des produits de santé France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:

refractory overactive bladder
neuromodulation
sacral nerves

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013