Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder (HAVIR Bi)
Primary Purpose
Urinary Bladder, Overactive
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Unilateral electrode placement and testing
Bilateral electrode placement and testing
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring refractory overactive bladder, neuromodulation, sacral nerves
Eligibility 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
Sites / Locations
- Clinique Beau Soleil
- CHU de Nantes - Hôtel Dieu
- CHU de Nîmes - Hôpital Universitaire Carémeau
- APHP - Groupe Hospitalier Pitié-Salpetrière
- CHU de Rouen - Hôpital Charles Nicolle
- CHRU de Toulouse - Hôpital de Rangueil
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Unilateral testing
Bilateral testing
Arm Description
Following standard procedures, patients in this group will have unilateral testing for neuromodulation of the sacral nerves. Intervention: Unilateral electrode placement and testing
Patients in this group will have bilateral testing for neuromodulation of the sacral nerves. Intervention: Bilateral electrode placement and testing
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
presence/absence: 50% reduction in the number of daily mictions
presence/absence: 50% reduction in the number of pads/protections used per day
presence/absence: 50% reduction in the number of urge incontinence episodes per day
presence/absence: 50% reduction in the number of urge incontinence episodes with incontinence per day
Symptom severity as measured by the MHU score
MHU = Mesure Hanicap Urinaire
Yes/no: the patient was eligible for an implant
debimetry: flow rate per voiding
debimetry: urinary volume per voiding
Visual analog scale for pain at the implantation site
Visual analog scale for pain due to neuro stimulation (pain in legs or buttocks)
Presence/absence of infection of the implant or electrode
Change in quality of life: IQoL score
Change in quality of life: KHQ score
Change in quality of life: SF 36 score
Full Information
NCT ID
NCT01558856
First Posted
March 18, 2012
Last Updated
August 3, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT01558856
Brief Title
Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
Acronym
HAVIR Bi
Official Title
Prospective Randomized Trial Comparing Unilateral and Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2012 (Actual)
Primary Completion Date
September 20, 2017 (Actual)
Study Completion Date
January 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
refractory overactive bladder, neuromodulation, sacral nerves
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unilateral testing
Arm Type
Active Comparator
Arm Description
Following standard procedures, patients in this group will have unilateral testing for neuromodulation of the sacral nerves.
Intervention: Unilateral electrode placement and testing
Arm Title
Bilateral testing
Arm Type
Experimental
Arm Description
Patients in this group will have bilateral testing for neuromodulation of the sacral nerves.
Intervention: Bilateral electrode placement and testing
Intervention Type
Procedure
Intervention Name(s)
Unilateral electrode placement and testing
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bilateral electrode placement and testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success rate
Description
"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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
presence/absence: 50% reduction in the number of daily mictions
Time Frame
1 month
Title
presence/absence: 50% reduction in the number of pads/protections used per day
Time Frame
1 month
Title
presence/absence: 50% reduction in the number of urge incontinence episodes per day
Time Frame
1 month
Title
presence/absence: 50% reduction in the number of urge incontinence episodes with incontinence per day
Time Frame
1 month
Title
Symptom severity as measured by the MHU score
Description
MHU = Mesure Hanicap Urinaire
Time Frame
1 month
Title
Yes/no: the patient was eligible for an implant
Time Frame
1 month
Title
debimetry: flow rate per voiding
Time Frame
1 month
Title
debimetry: urinary volume per voiding
Time Frame
1 month
Title
Visual analog scale for pain at the implantation site
Time Frame
1 month
Title
Visual analog scale for pain due to neuro stimulation (pain in legs or buttocks)
Time Frame
1 month
Title
Presence/absence of infection of the implant or electrode
Time Frame
1 month
Title
Change in quality of life: IQoL score
Time Frame
baseline to 1 month
Title
Change in quality of life: KHQ score
Time Frame
baseline to 1 month
Title
Change in quality of life: SF 36 score
Time Frame
baseline to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Wagner, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Beau Soleil
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France
Facility Name
APHP - Groupe Hospitalier Pitié-Salpetrière
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
CHU de Rouen - Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHRU de Toulouse - Hôpital de Rangueil
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
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