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NCT00141128 Clinical Trial

Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.

Urinary Incontinence, Stress Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00141128
Other study ID # A6061024
Secondary ID
Status Completed
Phase Phase 2
First received August 29, 2005
Last updated May 31, 2011
Start date December 2005
Est. completion date June 2006

Study information
Verified date May 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

SS-RBX will be used to evaluate pharmacodynamic changes in urethral function using a novel methodology

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Female

- Stress urinary incontinence

Exclusion Criteria:

- Bladder outflow obstruction

- Neurological disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SS-RBX

Locations
Country Name City State
Denmark Pfizer Investigational Site Glostrup

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.
Secondary To assess the effect of [S,S]-Reboxetine on urethral function in women with SUI.
See also
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Completed NCT02296099 - Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence Phase 4
Completed NCT02599051 - Transobturator Verus Single Incision Slings N/A
Completed NCT00138749 - An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence. Phase 2
Terminated NCT03614611 - Canadian Experience With Contiform Intravaginal Device For The Treatment Of Stress Incontinence N/A
Completed NCT03722719 - The Knack on Female Stress Urinary Incontinence N/A
Active, not recruiting NCT02275728 - Pelvic Floor Muscle Training With and Without Biofeedback in Women With Stress Urinary Incontinence N/A
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