Urinary Bladder, OveractiveHAVIR BiNCT01558856
Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
A study testing Unilateral electrode placement and testing and Bilateral electrode placement and testing in people with Urinary Bladder, Overactive, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
Trial summary
The primary objective of this study is to compare the efficacy of unilateral and bilateral neuromodulation tests at 1 month. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Unilateral electrode placement and testing and Bilateral electrode placement and testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 6 sitesFrance
- Study dates
- 23 Oct 2012to 23 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Clinique Beau Soleil
Montpellier, 34070
CHU de Nantes - Hôtel Dieu
Nantes, 44093
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, 75651
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76031
CHRU de Toulouse - Hôpital de Rangueil
Toulouse, 31059
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Unilateral electrode placement and testing, Bilateral electrode placement and testing
- Keywords
- refractory overactive bladder, neuromodulation, sacral nerves
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral electrode placement and testingProcedure or surgery
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.
Bilateral electrode placement and testingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Bilateral electrode placement and testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (14)
presence/absence: 50% reduction in the number of daily mictions
Measured: 1 month
presence/absence: 50% reduction in the number of pads/protections used per day
Measured: 1 month
presence/absence: 50% reduction in the number of urge incontinence episodes per day
Measured: 1 month
presence/absence: 50% reduction in the number of urge incontinence episodes with incontinence per day
Measured: 1 month
Symptom severity as measured by the MHU score
MHU = Mesure Hanicap Urinaire
Measured: 1 month
Yes/no: the patient was eligible for an implant
Measured: 1 month
debimetry: flow rate per voiding
Measured: 1 month
debimetry: urinary volume per voiding
Measured: 1 month
Visual analog scale for pain at the implantation site
Measured: 1 month
Visual analog scale for pain due to neuro stimulation (pain in legs or buttocks)
Measured: 1 month
Presence/absence of infection of the implant or electrode
Measured: 1 month
Change in quality of life: IQoL score
Measured: baseline to 1 month
Change in quality of life: KHQ score
Measured: baseline to 1 month
Change in quality of life: SF 36 score
Measured: baseline to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study start23 Oct 2012
- Primary completion20 Sep 2017
- Study completion23 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Wagner, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558856
- Sponsor's protocol ID
- LOCAL/2011/PW-04
- Other IDs
- 2012-A00185-38
- Acronym
- HAVIR Bi
- Status last verified
- Aug 2020
- First submitted
- 18 Mar 2012
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32835443
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Unilateral and Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
- ClinicalTrials.gov ID
- NCT01558856
- Acronym / sponsor ID
- HAVIR Bi / LOCAL/2011/PW-04
- Conditions
- Urinary Bladder, Overactive
- Keywords
- refractory overactive bladder, neuromodulation, sacral nerves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 23 Oct 2012 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 23 Jan 2018 (actual)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the efficacy of unilateral and bilateral neuromodulation tests at 1 month.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral testing | Active comparator | Procedure: Unilateral electrode placement and testingFollowing standard procedures, patients in this group will have unilateral testing for neuromodulation of the sacral nerves. Intervention: Unilateral electrode placement and testing |
| Bilateral testing | Experimental | Procedure: Bilateral electrode placement and testingPatients in this group will have bilateral testing for neuromodulation of the sacral nerves. Intervention: Bilateral electrode placement and testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral electrode placement and testingAn 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 or surgery | Unilateral testing |
| Bilateral electrode placement and testingTwo 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. | Procedure or surgery | Bilateral testing |
Primary outcome
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.
14 secondary outcomes
presence/absence: 50% reduction in the number of daily mictions
Time frame: 1 month
presence/absence: 50% reduction in the number of pads/protections used per day
Time frame: 1 month
presence/absence: 50% reduction in the number of urge incontinence episodes per day
Time frame: 1 month
presence/absence: 50% reduction in the number of urge incontinence episodes with incontinence per day
Time frame: 1 month
Symptom severity as measured by the MHU score
Time frame: 1 month
Yes/no: the patient was eligible for an implant
Time frame: 1 month
debimetry: flow rate per voiding
Time frame: 1 month
debimetry: urinary volume per voiding
Time frame: 1 month
Visual analog scale for pain at the implantation site
Time frame: 1 month
Visual analog scale for pain due to neuro stimulation (pain in legs or buttocks)
Time frame: 1 month
Presence/absence of infection of the implant or electrode
Time frame: 1 month
Change in quality of life: IQoL score
Time frame: baseline to 1 month
Change in quality of life: KHQ score
Time frame: baseline to 1 month
Change in quality of life: SF 36 score
Time frame: baseline to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 32835443Wagner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Wagner, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral electrode placement and testing and Bilateral electrode placement and testing in people with Urinary Bladder, Overactive, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01558856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.