Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures (DISST)
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|ClinicalTrials.gov Identifier: NCT03120117|
Recruitment Status : Unknown
Verified April 2017 by Salil Khandwala MD, Michigan Institution of Women's Health PC.
Recruitment status was: Active, not recruiting
First Posted : April 19, 2017
Last Update Posted : April 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence||Procedure: Cough Test following Sling Surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures|
|Actual Study Start Date :||August 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2018|
Experimental: Cough Test following Sling Surgery
All subjects enrolled will undergo sling surgery for treatment of stress urinary incontinence and subsequently asked to do a standing cough test.
Procedure: Cough Test following Sling Surgery
Enrolled subjects will undergo sling surgery who present with stress-dominated urinary incontinence. While in the operating room, the subject will be asked to stand and cough to determine if there is still leakage once the sling has been placed.
Other Name: DISST Procedure
- Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative cough test. [ Time Frame: Within first two years following sling procedure ]Success criteria will be defined through the examination of patient's post-operative visits regarding cough stress tests in supine, sitting and standing positions where the bladder is at 10% of urodynamic fullness. Failure to meet this criteria will be considered recurrence of stress incontinence.
- Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative MESA questionnaire. [ Time Frame: Within first two years following sling procedure ]Success criteria is also defined through the examination of patient's response to Medical Epidemiologic and Social Aspects of Aging 12 (MESA) to determine recurrence of stress incontinence. Failure to meet this criteria will be considered recurrence of stress incontinence.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120117
|United States, Michigan|
|Advanced Urogynecology of Michigan, P.C.|
|Dearborn, Michigan, United States, 48124|
|Principal Investigator:||Salil Khandwala, MD||Michigan Institute of Women's Health|