Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder (HAVIR Bi)

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

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

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Overactive
• Intervention / Treatment: Procedure: Unilateral electrode placement and testing; Procedure: Bilateral electrode placement and testing

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34070
    • Clinique Beau Soleil
  • Nantes Cedex 1, France, 44093
    • CHU de Nantes - Hotel Dieu
  • Nîmes Cedex 09, France, 30029
    • CHU de Nîmes - Hôpital Universitaire Carémeau
  • Paris Cedex 13, France, 75651
    • APHP - Groupe Hospitalier Pitié-Salpetrière
  • Rouen, France, 76031
    • CHU de Rouen - Hopital Charles Nicolle
  • Toulouse Cedex 9, France, 31059
    • CHRU de Toulouse - Hôpital de Rangueil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	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. Intervention: Bilateral electrode placement and testing	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Laurent Wagner, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 23, 2012
• Primary Completion (ACTUAL): September 20, 2017
• Study Completion (ACTUAL): January 23, 2018

Study Registration Dates

• First Submitted: March 18, 2012
• First Submitted That Met QC Criteria: March 18, 2012
• First Posted (ESTIMATE): March 20, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: neuromodulation; refractory overactive bladder; sacral nerves
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: LOCAL/2011/LW-04; 2012-A00185-38 (OTHER: RCB number)