Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-04-06 @ 9:23 AM
Study NCT ID:
NCT01530620
Status:
COMPLETED
Last Update Posted:
2012-02-10
First Post:
2012-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder 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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C015586', 'term': 'propiverine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-09', 'studyFirstSubmitDate': '2012-02-02', 'studyFirstSubmitQcDate': '2012-02-09', 'lastUpdatePostDateStruct': {'date': '2012-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reflex volume (cystometry)', 'timeFrame': 'three weeks', 'description': 'Change in reflex volume compared to baseline and compared between the two treatment arms'}], 'secondaryOutcomes': [{'measure': 'Leak point pressure', 'timeFrame': 'three weeks', 'description': 'Change in LPP compared to baseline and compared between the two treatment arms'}, {'measure': 'Leak point volume', 'timeFrame': 'three weeks', 'description': 'Change in LPV compared to baseline and compared between the two treatment arms'}, {'measure': 'Maximum detrusor pressure', 'timeFrame': 'three weeks', 'description': 'Change in maximum p det compared to baseline and compared between the two treatment arms'}, {'measure': 'Maximum cystometric capacity', 'timeFrame': 'three weeks', 'description': 'Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms'}, {'measure': 'Bladder compliance', 'timeFrame': 'three weeks', 'description': 'Change in compliance compared to baseline and compared between the two treatment arms'}, {'measure': 'Change in number of incontinence episodes', 'timeFrame': 'three weeks', 'description': 'Change of incontinence episodes compared to baseline and compared between the two treatment arms'}, {'measure': 'State of Well-Being Questionnaire', 'timeFrame': 'three weeks', 'description': 'Change of well-beeing compared to baseline and compared between the two treatment arms'}, {'measure': 'Post void residual volume', 'timeFrame': 'three weeks', 'description': 'Change in PVR compared to baseline and compared between the two treatment arms'}, {'measure': 'Incidence and severity of adverse events', 'timeFrame': 'three weeks', 'description': 'occurrences and intensity of adverse events or withdrawals over the whole treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antimuscarinics', 'Neurogenic bladder', 'Propiverine', 'Urodynamics'], 'conditions': ['Neurogenic Urinary Bladder Disorder', 'Urinary Bladder, Neurogenic', 'Bladder Disorder, Neurogenic', 'Urinary Bladder Disorder, Neurogenic', 'Neurogenic Bladder Disorder', 'Urinary Bladder Neurogenic Dysfunction', 'Urologic Diseases', 'Overactive Detrusor Function', 'Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female Caucasian patients aged ≥18 and ≤70 years\n* Voluntarily signed informed consent\n* Neurogenic detrusor overactivity with occurrence of reflex detrusor contractions\n* Reflex volume of ≤250 mL\n* Intact reflex arcs in the area of segments S2-S4\n\nExclusion Criteria:\n\n* Patients suffering from multiple sclerosis under unstable conditions\n* Augmented reflex bladder\n* Patients with increased residual urine (≥20 % of the maximum bladder capacity), in whom catheterization is not possible\n* Acute urinary tract infection\n* Electrostimulation therapy (within 4 weeks propir to Visit 1)\n* Anomalies of the lower genitourinary tract (e.g. ectopic ureters, fistulas, urethral stenosis)\n* Radiation bladder, interstitial cystitis, bladder calculi, bladder carcinoma\n* Surgery of the lower genitourinary tract within the last 6 months (e.g. prostatectomy, hysterectomy, tumor surgery)\n* Pre-existing medical contraindications for anticholinergics\n* Cardiac insufficiency (NYHA stage III/ IV)\n* Therapy with botulinum toxin within the last 12 months\n* Evidence of severe renal, hepatic or metabolic disorders\n* History of drug or alcohol abuse\n* Concomitant medication known to have a potential to interfere with the trial medication\n* Known hypersensitivity to Propiverine hydrochloride or excipients contained in the trial medication, respectively\n* Pregnant or breast-feeding women, or women of childbearing potential without using any reliable contraceptive method\n* Patients with impaired co-operation or who are unable to understand the nature, scope and possible consequences of the study'}, 'identificationModule': {'nctId': 'NCT01530620', 'briefTitle': 'Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity', 'organization': {'class': 'INDUSTRY', 'fullName': 'APOGEPHA Arzneimittel GmbH'}, 'officialTitle': 'Efficacy and Tolerability of Propiverine Hydrochloride Extended Release (ER) Compared to Immediate Release (IR) in Patients With Neurogenic Detrusor Overactivity. A Randomized, Double Blind, Parallel Group, Multicenter Clinical Trial', 'orgStudyIdInfo': {'id': '8405010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propiverine hydrochloride ER', 'description': '45 mg', 'interventionNames': ['Drug: Propiverine hydrochloride ER (extended release)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propiverine hydrochloride IR', 'description': '15 mg', 'interventionNames': ['Drug: Propiverine hydrochloride IR (immediate release)']}], 'interventions': [{'name': 'Propiverine hydrochloride ER (extended release)', 'type': 'DRUG', 'otherNames': ['Mictonorm UNO 45', 'Detrunorm XL 45'], 'description': '45 mg capsule (1x1/d)', 'armGroupLabels': ['Propiverine hydrochloride ER']}, {'name': 'Propiverine hydrochloride IR (immediate release)', 'type': 'DRUG', 'otherNames': ['Mictonorm', 'Detrunorm'], 'description': '15 mg tablet (3x1/d)', 'armGroupLabels': ['Propiverine hydrochloride IR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Hagenow', 'country': 'Germany', 'geoPoint': {'lat': 53.43203, 'lon': 11.19165}}, {'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'APOGEPHA Arzneimittel GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}