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

November 18, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34070
        • Clinique Beau Soleil
      • Nantes, France, 44093
        • CHU de Nantes - Hôtel Dieu
      • Nîmes, France, 30029
        • CHU de Nîmes - Hopital Universitaire Caremeau
      • Paris, France, 75651
        • APHP - Groupe Hospitalier Pitié-Salpetrière
      • Rouen, France, 76031
        • CHU de Rouen - Hôpital Charles Nicolle
      • Toulouse, France, 31059
        • CHRU de Toulouse - Hôpital de Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: 1 month
"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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
presence/absence: 50% reduction in the number of daily mictions
Time Frame: 1 month
1 month
presence/absence: 50% reduction in the number of pads/protections used per day
Time Frame: 1 month
1 month
presence/absence: 50% reduction in the number of urge incontinence episodes per day
Time Frame: 1 month
1 month
presence/absence: 50% reduction in the number of urge incontinence episodes with incontinence per day
Time Frame: 1 month
1 month
Symptom severity as measured by the MHU score
Time Frame: 1 month
MHU = Mesure Hanicap Urinaire
1 month
Yes/no: the patient was eligible for an implant
Time Frame: 1 month
1 month
debimetry: flow rate per voiding
Time Frame: 1 month
1 month
debimetry: urinary volume per voiding
Time Frame: 1 month
1 month
Visual analog scale for pain at the implantation site
Time Frame: 1 month
1 month
Visual analog scale for pain due to neuro stimulation (pain in legs or buttocks)
Time Frame: 1 month
1 month
Presence/absence of infection of the implant or electrode
Time Frame: 1 month
1 month
Change in quality of life: IQoL score
Time Frame: baseline to 1 month
baseline to 1 month
Change in quality of life: KHQ score
Time Frame: baseline to 1 month
baseline to 1 month
Change in quality of life: SF 36 score
Time Frame: baseline to 1 month
baseline to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurent Wagner, MD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2012

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOCAL/2011/PW-04
  • 2012-A00185-38 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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