Eligibility criteria
Condition
Stress Urinary Incontinence
Sex
Female
Age
18-65 years
Inclusion criteria
Show details
- Female
- Stress urinary incontinence
Exclusion criteria
Show details
- Bladder outflow obstruction
- Neurological disease
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Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.
NCT00141128
Last updated on November 13, 2019
About this Study
SS-RBX will be used to evaluate pharmacodynamic changes in urethral function using a novel methodology
NCT00141128
Pfizer
Completed
Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX. | |||
| Official Title ICMJE | Measurement Of Urethral Function In Women With Stress Urinary Incontinence - Evaluation Of The Sensitivity Of Urethral Reflectometry Compared To Urethral Pressure Profilometry, Using [S,S]-Reboxetine To Detect Pharmacological Augmentation Of Urethral Pressure. | |||
| Brief Summary | SS-RBX will be used to evaluate pharmacodynamic changes in urethral function using a novel methodology | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE | Urinary Incontinence, Stress | |||
| Intervention ICMJE | Drug: SS-RBX | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Klarskov N, Scholfield D, Soma K, Darekar A, Mills I, Lose G. Measurement of urethral closure function in women with stress urinary incontinence. J Urol. 2009 Jun;181(6):2628-33; discussion 2633. doi: 10.1016/j.juro.2009.01.114. Epub 2009 Apr 16. | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 18 | |||
| Original Enrollment ICMJE | 40 | |||
| Actual Study Completion Date ICMJE | June 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Denmark | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00141128 | |||
| Other Study ID Numbers ICMJE | A6061024 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | May 2011 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Pfizer Clinical Trials Contact Center
1-800-718-1021