Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-03 @ 2:55 AM
Study NCT ID:
NCT01558856
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2012-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2012-03-18', 'studyFirstSubmitQcDate': '2012-03-18', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate', 'timeFrame': '1 month', '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.'}], 'secondaryOutcomes': [{'measure': 'presence/absence: 50% reduction in the number of daily mictions', 'timeFrame': '1 month'}, {'measure': 'presence/absence: 50% reduction in the number of pads/protections used per day', 'timeFrame': '1 month'}, {'measure': 'presence/absence: 50% reduction in the number of urge incontinence episodes per day', 'timeFrame': '1 month'}, {'measure': 'presence/absence: 50% reduction in the number of urge incontinence episodes with incontinence per day', 'timeFrame': '1 month'}, {'measure': 'Symptom severity as measured by the MHU score', 'timeFrame': '1 month', 'description': 'MHU = Mesure Hanicap Urinaire'}, {'measure': 'Yes/no: the patient was eligible for an implant', 'timeFrame': '1 month'}, {'measure': 'debimetry: flow rate per voiding', 'timeFrame': '1 month'}, {'measure': 'debimetry: urinary volume per voiding', 'timeFrame': '1 month'}, {'measure': 'Visual analog scale for pain at the implantation site', 'timeFrame': '1 month'}, {'measure': 'Visual analog scale for pain due to neuro stimulation (pain in legs or buttocks)', 'timeFrame': '1 month'}, {'measure': 'Presence/absence of infection of the implant or electrode', 'timeFrame': '1 month'}, {'measure': 'Change in quality of life: IQoL score', 'timeFrame': 'baseline to 1 month'}, {'measure': 'Change in quality of life: KHQ score', 'timeFrame': 'baseline to 1 month'}, {'measure': 'Change in quality of life: SF 36 score', 'timeFrame': 'baseline to 1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['refractory overactive bladder', 'neuromodulation', 'sacral nerves'], 'conditions': ['Urinary Bladder, Overactive']}, 'referencesModule': {'references': [{'pmid': '32835443', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the efficacy of unilateral and bilateral neuromodulation tests at 1 month.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is available for 1 month of follow-up\n* The patient understands and reads French\n* The patient has symptoms of overactive bladder resistant to first-line treatments (physiotherapy, anticholinergics)\n* The patient suffers from an overactive bladder confirmed by a urodynamic panel\n* The patient suffers from an overactive bladder unassociated with bladder obstruction as confirmed by flowmetry\n* The patient has primary (idiopathic) overactive bladder primary with normal urinalysis, abdominal and pelvic ultrasound, urine cytology + / - cystoscopy\n* The patient has no bleeding disorders, or the disorder is properly controlled after treatment\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* The patient is pregnant, parturient, or breastfeeding\n* Overactive bladder associated with bladder obstruction as determined by flowmetry\n* Overactive bladder unconfirmed by urodynamic panel\n* Overactive bladder secondary to another condition:\n* vesical: urolithiasis, bladder polyp, interstitial cystitis\n* pelivienne: tumor or inflammatory\n* neurological: multiple sclerosis, brain tumor, epilepsy\n* the patient has an uncorrectable bleeding disorder'}, 'identificationModule': {'nctId': 'NCT01558856', 'acronym': 'HAVIR Bi', 'briefTitle': 'Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Prospective Randomized Trial Comparing Unilateral and Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder', 'orgStudyIdInfo': {'id': 'LOCAL/2011/PW-04'}, 'secondaryIdInfos': [{'id': '2012-A00185-38', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Unilateral testing', 'description': 'Following standard procedures, patients in this group will have unilateral testing for neuromodulation of the sacral nerves.\n\nIntervention: Unilateral electrode placement and testing', 'interventionNames': ['Procedure: Unilateral electrode placement and testing']}, {'type': 'EXPERIMENTAL', 'label': 'Bilateral testing', 'description': 'Patients in this group will have bilateral testing for neuromodulation of the sacral nerves.\n\nIntervention: Bilateral electrode placement and testing', 'interventionNames': ['Procedure: Bilateral electrode placement and testing']}], 'interventions': [{'name': 'Unilateral electrode placement and testing', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Unilateral testing']}, {'name': 'Bilateral electrode placement and testing', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Bilateral testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34070', 'city': 'Montpellier', 'country': 'France', 'facility': 'Clinique Beau Soleil', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes - Hôtel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'APHP - Groupe Hospitalier Pitié-Salpetrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU de Rouen - Hôpital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHRU de Toulouse - Hôpital de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Laurent Wagner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}