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

NCT01558856 | Completed

• 2 other identifiers: LOCAL/2011/PW-042012-A00185-38
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Urinary Bladder, Overactive

Keywords

refractory overactive bladder; neuromodulation; sacral nerves

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

  1 month

Study Arms (2)

Unilateral testing

ACTIVE COMPARATOR

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

Bilateral testing

EXPERIMENTAL

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

Interventions

Unilateral electrode placement and testing 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.

Unilateral testing

Bilateral electrode placement and testing 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.

Bilateral testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (6)

Clinique Beau Soleil

Montpellier, 34070, France

Location

CHU de Nantes - Hôtel Dieu

Nantes, 44093, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

APHP - Groupe Hospitalier Pitié-Salpetrière

Paris, 75651, France

Location

CHU de Rouen - Hôpital Charles Nicolle

Rouen, 76031, France

Location

CHRU de Toulouse - Hôpital de Rangueil

Toulouse, 31059, France

Location

Related Publications (1)

• Wagner L, Alonso S, Le Normand L, Faix A, Kabani S, Castelli C, Game X, Cornu JN, Bey E. Unilateral versus bilateral sacral neuromodulation test in the treatment of refractory idiopathic overactive bladder: A randomized controlled pilot trial. Neurourol Urodyn. 2020 Nov;39(8):2230-2237. doi: 10.1002/nau.24476. Epub 2020 Aug 24.

  PMID: 32835443 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent Wagner, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2012
• First Posted: March 20, 2012
• Study Start: October 23, 2012
• Primary Completion: September 20, 2017
• Study Completion: January 23, 2018
• Last Updated: November 21, 2025

Record last verified: 2020-08

Locations

FR (6)