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Tracking Information | |||||
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First Received Date † | September 13, 2005 | ||||
Last Updated Date | April 8, 2009 | ||||
Start Date † | May 2004 | ||||
Current Primary Outcome Measures † |
3 month follow-up visit [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00194610 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Botox as a Treatment for Interstitial Cystitis in Women | ||||
Official Title † | Botox (Botulinum Toxin A) as a Treatment for Interstitial Cystitis in Women: A Randomized Placebo Controlled Trial | ||||
Brief Summary | Patients with interstitial cystitis have been well documented to have pelvic floor muscle tenderness as well as pain on bladder distension. Some investigators have even suggested that pelvic floor muscle pain is primarily the cause of bladder problems. Botulinum toxin A causes muscle relaxation by inhibiting the acetylcholine release at the neuromuscular junction. It has been shown that this mechanism relieves pain in a number of muscle spasm-related syndromes. Because, at present, there is little effective therapy available for patients with interstitial cystitis, the researchers want to determine if 100 units of botulinum toxin A will relieve bladder and pelvic pain in these patients. |
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Detailed Description | Screening Visit: After being screened by her caregiver, the patient will be given the opportunity to ask questions about the study. She will then be asked to read and sign the consent and then be randomized. Then, for women of childbearing age, a pregnancy test will be done. Next, we will ask the patient to fill out baseline study forms and she will be given a Voiding Diary. She will also be asked to provide a urine sample which will be processed for chemistry. Injection Visit: This visit will be scheduled one week after the Screening Visit. First, a standard history and physical will be done. Then the clinician will proceed with the injection. The subject will receive an injection of not more than 5 ml of 1% lidocaine without epinephrine at the site of the botulinum toxin A injection. Next, 25 units of Botox will be injected, via the transvaginal route, on either side of the bladder neck. The remaining 50 units will be injected (in 2
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Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study | ||||
Condition † |
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Intervention † | Drug: Botulinum Toxin A (Botox) | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* 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 † | Active, not recruiting | ||||
Enrollment † | 30 | ||||
Estimated Completion Date | December 2010 | ||||
Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00194610 | ||||
Responsible Party | Jane L. Miller, MD, Principal Investigator, University of Washington | ||||
Secondary IDs †† | |||||
Study Sponsor † | University of Washington | ||||
Collaborators †† | Paul G. Allen Family Foundation | ||||
Investigators † |
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Information Provided By | University of Washington | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |