Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT01640002
Status:
UNKNOWN
Last Update Posted:
2012-07-13
First Post:
2012-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011413', 'term': 'Propantheline'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D014966', 'term': 'Xanthenes'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-12', 'studyFirstSubmitDate': '2012-07-11', 'studyFirstSubmitQcDate': '2012-07-12', 'lastUpdatePostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improve in Overactive bladder symptoms score', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Improvement in nocturia and urgency', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['overactive bladder', 'HTLV-1', 'Propantheline', 'anticholinergic'], 'conditions': ['Overactive Bladder Associated With HTLV-1']}, 'referencesModule': {'references': [{'pmid': '17352816', 'type': 'BACKGROUND', 'citation': 'Rocha PN, Rehem AP, Santana JF, Castro N, Muniz AL, Salgado K, Rocha H, Carvalho EM. The cause of urinary symptoms among Human T Lymphotropic Virus Type I (HLTV-I) infected patients: a cross sectional study. BMC Infect Dis. 2007 Mar 12;7:15. doi: 10.1186/1471-2334-7-15.'}, {'pmid': '21388871', 'type': 'BACKGROUND', 'citation': 'Poetker SK, Porto AF, Giozza SP, Muniz AL, Caskey MF, Carvalho EM, Glesby MJ. Clinical manifestations in individuals with recent diagnosis of HTLV type I infection. J Clin Virol. 2011 May;51(1):54-8. doi: 10.1016/j.jcv.2011.02.004. Epub 2011 Mar 8.'}, {'pmid': '17411369', 'type': 'BACKGROUND', 'citation': 'Caskey MF, Morgan DJ, Porto AF, Giozza SP, Muniz AL, Orge GO, Travassos MJ, Barron Y, Carvalho EM, Glesby MJ. Clinical manifestations associated with HTLV type I infection: a cross-sectional study. AIDS Res Hum Retroviruses. 2007 Mar;23(3):365-71. doi: 10.1089/aid.2006.0140.'}, {'pmid': '10426153', 'type': 'BACKGROUND', 'citation': 'Gomes I, Melo A, Proietti FA, Moreno-Carvalho O, Loures LA, Dazza MC, Said G, Larouze B, Galvao-Castro B. Human T lymphotropic virus type I (HTLV-I) infection in neurological patients in Salvador, Bahia, Brazil. J Neurol Sci. 1999 May 1;165(1):84-9. doi: 10.1016/s0022-510x(99)00083-0.'}, {'pmid': '20038241', 'type': 'BACKGROUND', 'citation': 'Garlet GP, Giozza SP, Silveira EM, Claudino M, Santos SB, Avila-Campos MJ, Martins W Jr, Cardoso CR, Trombone AP, Campanelli AP, Carvalho EM, Silva JS. Association of human T lymphotropic virus 1 amplification of periodontitis severity with altered cytokine expression in response to a standard periodontopathogen infection. Clin Infect Dis. 2010 Feb 1;50(3):e11-8. doi: 10.1086/649871.'}, {'pmid': '21541226', 'type': 'BACKGROUND', 'citation': 'Tannus M, Tanajura D, Sundberg MA, Oliveira P, Castro N, Santos AM. Detrusor Arreflexia as an End Stage of Neurogenic Bladder in HAM/TSP? Case Rep Med. 2011;2011:289389. doi: 10.1155/2011/289389. Epub 2011 Apr 13.'}, {'pmid': '2005707', 'type': 'BACKGROUND', 'citation': 'Thuroff JW, Bunke B, Ebner A, Faber P, de Geeter P, Hannappel J, Heidler H, Madersbacher H, Melchior H, Schafer W, et al. Randomized, double-blind, multicenter trial on treatment of frequency, urgency and incontinence related to detrusor hyperactivity: oxybutynin versus propantheline versus placebo. J Urol. 1991 Apr;145(4):813-6; discussion 816-7. doi: 10.1016/s0022-5347(17)38459-8.'}, {'pmid': '21855969', 'type': 'BACKGROUND', 'citation': 'Gotoh M, Homma Y, Yokoyama O, Nishizawa O. Responsiveness and minimal clinically important change in overactive bladder symptom score. Urology. 2011 Oct;78(4):768-73. doi: 10.1016/j.urology.2011.06.020.'}, {'pmid': '17482910', 'type': 'RESULT', 'citation': 'Castro NM, Rodrigues W Jr, Freitas DM, Muniz A, Oliveira P, Carvalho EM. Urinary symptoms associated with human T-cell lymphotropic virus type I infection: evidence of urinary manifestations in large group of HTLV-I carriers. Urology. 2007 May;69(5):813-8. doi: 10.1016/j.urology.2007.01.052.'}, {'pmid': '20189229', 'type': 'RESULT', 'citation': 'Oliveira P, Castro NM, Muniz AL, Tanajura D, Brandao JC, Porto AF, Carvalho EM. Prevalence of erectile dysfunction in HTLV-1-infected patients and its association with overactive bladder. Urology. 2010 May;75(5):1100-3. doi: 10.1016/j.urology.2009.11.041. Epub 2010 Feb 26.'}]}, 'descriptionModule': {'briefSummary': "It's a double blind, placebo controlled study to assess the efficacy of Propantheline Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients.\n\nWe think that the treatment of the OAB with Propantheline could reduce nocturia and frequency in sixty percent.", 'detailedDescription': 'Double blind, placebo controlled study to assess the efficacy of Propantheline Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients\n\nTreatment Group Propantheline Bromide: 15mg, three times daily for 08 weeks.\n\nControl Group Placebo 03 times daily\n\nCase definition Clinically defined OAB patients (ICS criteria), infected by HTLV-1. Frequency was defined as more than 08 daytime voids. Nocturia was defined as more than 02 voids after sleeping.\n\nInclusion criteria More than 18 year. HTLV-1 infected patients with overactive bladder. Negative culture of urine. Without neurological impairment.\n\nExclusion criteria Persistently positive urine culture\n\nHistory of:\n\nAllergy to medication, head or spinal trauma. Head and neck, neurological,spinal, lower abdominal or pelvic surgery. Stroke. Users of urinary catheters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HTLV-1 infection\n* More than 18 years\n* Negative urine culture\n* No neurological damage\n\nExclusion Criteria:\n\n* Diabetes\n* Persistently positive urine culture\n* Pelvic, head, urological or gynecological surgery\n* Stroke'}, 'identificationModule': {'nctId': 'NCT01640002', 'briefTitle': 'A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitário Professor Edgard Santos'}, 'officialTitle': 'A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder', 'orgStudyIdInfo': {'id': 'FR-473218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propantheline', 'interventionNames': ['Drug: Propantheline Bromide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Propantheline Bromide', 'type': 'DRUG', 'description': '15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.', 'armGroupLabels': ['Propantheline']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40110-070', 'city': 'Salvador', 'state': 'Estado de Bahia', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'José Abraão Carneiro Neto', 'role': 'CONTACT', 'email': 'abraao.neto@gmail.com', 'phone': '557132838392'}, {'name': 'Edgard Marcelino Carvalho Filho', 'role': 'CONTACT', 'email': 'imuno@ufba.br'}, {'name': 'Edgard Marcelino Carvalho Filho', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service of Imunology - Universitary Hospital Prof. Edgard Santos', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'centralContacts': [{'name': 'Jose Abraão Carneiro Neto', 'role': 'CONTACT', 'email': 'abraao.neto@gmail.com', 'phone': '55+71+8149-1252'}], 'overallOfficials': [{'name': 'José Abraão Carneiro Neto', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service of Imunology - Universitary Hospital Prof. Edgard Santos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitário Professor Edgard Santos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jose Abraao Carneiro Neto', 'investigatorAffiliation': 'Hospital Universitário Professor Edgard Santos'}}}}