Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT00839969
Status:
UNKNOWN
Last Update Posted:
2009-02-10
First Post:
2009-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cystoscopy Plus Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003558', 'term': 'Cystoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-09', 'studyFirstSubmitDate': '2009-02-09', 'studyFirstSubmitQcDate': '2009-02-09', 'lastUpdatePostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in pressure flow parameters (voided volume, maximum flow rate, acceleration of flow rate and detrusor pressure at maximum flow) at 6 weeks' post-operatively.", 'timeFrame': '6 weeks'}, {'measure': "Change in symptoms as measured by the BFLUTS questionnaire and Urgency Perception Scale at 6 weeks' and 6 months' post-operatively.", 'timeFrame': '6 weeks and 6 months'}], 'secondaryOutcomes': [{'measure': "Change in quality of life status as determined by change in King's Health Questionnaire scoring at 6 weeks and 6 months' post-operatively.", 'timeFrame': '6 weeks and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['overactive bladder syndrome', 'voiding', 'pressure flow studies', 'urethral dilatation'], 'conditions': ['Overactive Bladder Syndrome', 'Voiding Dysfunction']}, 'referencesModule': {'references': [{'pmid': '23636866', 'type': 'DERIVED', 'citation': 'Basu M, Khullar V, Duckett J. Urethral dilatation: Is there any benefit over cystoscopy and distension? A randomized trial in women with overactive bladder symptoms. Neurourol Urodyn. 2014 Mar;33(3):283-8. doi: 10.1002/nau.22411. Epub 2013 May 1.'}]}, 'descriptionModule': {'briefSummary': "Urethral dilatation is a commonly undertaken intervention for a variety of urinary complaints including overactive bladder symptoms. There is however very little evidence for its efficacy, and no randomized trial evidence. The aim of this study is to ascertain the effect of urethral dilatation on overactive bladder symptoms and on voiding parameters. The null hypothesis is that there will be no difference in symptoms or voiding parameters between the urethral dilatation and sham groups.\n\nEligible women will be assessed initially with a history and examination, a King's Health Questionnaire and Bristol Female Urinary Tract Symptoms (BFLUTS) questionnaire and pressure flow studies. They will be randomized to undergo either cystoscopy alone or cystoscopy and urethral dilatation. Patients will be blinded to the procedure undertaken and randomized using a series of opaque envelopes. Follow up will be at 6 weeks with repeat questionnaires and pressure flow studies. Subjective and objective outcomes will be compared between the two groups.", 'detailedDescription': "This study is a randomised controlled trial. Objective outcomes will be evaluated at 6 weeks' post-operatively. Subjective outcomes will be evaluated at 6 weeks' and 6 months' post-operatively.\n\nStudy Population Entry to the study will be offered to all women with OAB symptoms with impaired voiding on cystometry (flow rate less than 15mls/sec with volume of 200mls voided and a normal or high detrusor pressure at maximum flow), who have failed to improve with 2 different anticholinergic medications. Subjects will be recruited from the Urogynaecology clinic at Medway Maritime Hospital. A power calculation was carried out which showed a minimum sample size of 30 (i.e. 15 in each arm) to be necessary to ensure an 80% power with a significance level of 0.05.\n\nPre-operative Assessment All patients will undergo an initial assessment consisting of a full urogynaecogical history and examination, BFLUTS questionnaire and Urgency Perception Scale, and pressure flow studies. As mentioned before, each patient will have been treated with anticholinergic medications prior to being offered this intervention.\n\nSurgical Technique All procedures will be carried out under general anaesthesia. A dose of intravenous gentamicin will be given to each patient at induction. After emptying the bladder, saline cystoscopy will be carried out with a 30 degree cystoscope. The bladder mucosa will be systematically inspected for any abnormalities and the bladder filled either until the sphincter mechanism is overcome or to 1000mls. The bladder is emptied again and a second fill undertaken. The bladder mucosa is inspected for petechial haemorrhages, erythema and other signs of chronic cystitis on the second fill.\n\nIn subjects randomised to undergo urethral dilatation, this will be undertaken using Hagar dilators. There is no evidence in the literature regarding normal urethral calibre in women. Therefore, the urethra will be dilated to a maximum of 10 Hagar as per our unit's protocol. Women will be discharged on the same day, if they pass urine adequately.\n\nPost-operative Assessment Subjects will be seen in the Urogynaecology clinic at 6 weeks' post-operatively and assessed with a BFLUTS questionnaire, UPS and repeat pressure flow studies. Each patient will be assessed subjectively at 6 months' post-operatively using the symptom questionnaires.\n\nSignificance testing will be used to compare symptom scores and pressure flow parameters between each group pre- and post-operatively."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. OAB symptoms (based on relevant domains of BFLUTS questionnaire and Urgency Perception Scale) which have not improved with 2 anticholinergic treatments.\n2. Maximum flow rate of less than 15 ml/s on a volume voided of 200mls or more, with a normal or high detrusor pressure at maximum flow on pressure flow studies\n3. Patients must be able to give informed consent for the study\n\nExclusion Criteria:\n\n1. Presence of concurrent urodynamic stress incontinence\n2. Patient unfit or unwilling to undergo a general anaesthetic\n3. Patients with bladder pathology or haematuria of unknown origin\n4. Patients with neurological disorders (as these may affect voiding)'}, 'identificationModule': {'nctId': 'NCT00839969', 'briefTitle': 'Cystoscopy Plus Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding', 'organization': {'class': 'OTHER', 'fullName': 'Medway NHS Foundation Trust'}, 'officialTitle': 'A Randomized Study of Cystoscopy and Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding.', 'orgStudyIdInfo': {'id': '08/H1101/97'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Cystoscopy alone', 'description': 'Women in this arm will undergo saline cystoscopy under general anaesthesia only.', 'interventionNames': ['Procedure: Cystoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cystoscopy and urethral dilatation', 'description': 'Women in this group will undergo cystoscopy and urethral dilatation under general anaesthesia', 'interventionNames': ['Procedure: Cystoscopy and urethral dilatation']}], 'interventions': [{'name': 'Cystoscopy', 'type': 'PROCEDURE', 'description': 'Saline cystoscopy under general anaesthesia', 'armGroupLabels': ['Cystoscopy alone']}, {'name': 'Cystoscopy and urethral dilatation', 'type': 'PROCEDURE', 'description': 'Saline cystoscopy and urethral dilatation (using Hegar dilators) under general anaesthesia', 'armGroupLabels': ['Cystoscopy and urethral dilatation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ME7 5NY', 'city': 'Gillingham', 'state': 'Kent', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Jonathan Duckett, FRCOG', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Maya Basu, MBBS, BSc(Hons)', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medway Maritime Hospital', 'geoPoint': {'lat': 51.38914, 'lon': 0.54863}}], 'centralContacts': [{'name': 'Jonathan Duckett, FRCOG', 'role': 'CONTACT', 'email': 'jonathan.duckett@medway.nhs.uk', 'phone': '+1634 830000', 'phoneExt': '5154'}], 'overallOfficials': [{'name': 'Jonathan Duckett, FRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medway NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medway NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mr Jonathan Duckett', 'oldOrganization': 'Medway NHS Trust'}}}}