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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 23, 2007 | ||||||||
| Last Updated Date | September 3, 2009 | ||||||||
| Start Date ICMJE | April 2007 | ||||||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Subjective patient improvement in irritative urinary symptoms as measured by the Overactive Bladder Questionnaire (OAB-q) after 12 weeks intervention [ Time Frame: after 12 weeks of intervention ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Subjective patient improvement in irritative urinary symptoms as measured by the Overactive Bladder Questionnaire (OAB-q) after 12 weeks intervention | ||||||||
| Change History | Complete list of historical versions of study NCT00465894 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Subjective patient improvement in irritative urinary symptoms at 1 year of treatment by the OAB-Q questionnaire [ Time Frame: after 1year of treatment ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Detrol LA vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms | ||||||||
| Official Title ICMJE | Randomized Controlled Trial of Tolterodine in Combination With or Without Low-Dose Intra-Vaginal Estradiol Cream for the Treatment of Overactive Bladder in Post-Menopausal Women | ||||||||
| Brief Summary | The purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms. |
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| Detailed Description | Lower urinary tract bladder storage symptoms include urinary frequency, urinary urgency, nocturia and urge incontinence. Overactive Bladder (OAB)Syndrome is a condition in which urgency is the predominant symptom with or without urge incontinence and is usually accompanied by frequency and nocturia. The mainstay of treatment of women with OAB syndrome is treatment with anticholinergic medication as well as behavioral therapy. This method of treatment has demonstrated a 60% response rate as reported in the Cochrane Database of Systemic Reviews. In addition to anticholinergic therapy, vaginal atrophy is often corrected as part of a pharmacologic treatment plan. Vaginal atrophy is a condition this is vastly prevalent in post-menopausal women. It is thought to affect up to 48% of post-menopausal women. Many women with this condition experience vaginal dryness, irritation, painful intercourse, as well as urinary symptoms including dysuria, urgency, frequency, nocturia, incontinence and recurrent urinary tract infections. Comparison: tolterodine la compared to low dose intra-vaginal estrogen cream for the treatment of OAB symptoms |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Caregiver, Investigator), Active Control, Crossover Assignment | ||||||||
| Condition ICMJE | Overactive Bladder | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | May 2010 | ||||||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 40 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00465894 | ||||||||
| Responsible Party | Holly E. Richter, PH.D., M.D., Professor, Depart. of OB/GYN; Womens Pelvic Medicine & Reconstructive Surgery, University of Alabama at Birmingham | ||||||||
| Study ID Numbers ICMJE | F061208008, IIR - DRIVE | ||||||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||||||
| Collaborators ICMJE | Pfizer | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Alabama at Birmingham | ||||||||
| Verification Date | September 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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