Back to resultsImportance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures (DISST)
Primary Purpose
Stress Urinary Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cough Test following Sling Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Midurethral Slings
Eligibility Criteria
Inclusion Criteria:
- Patients who present with stress-dominant urinary incontinence
- Patients who have undergone a stress test documentation both in the supine and standing/sitting position.
- Patients who have completed child bearing.
- Patients between 21 and 89 years of age.
Exclusion Criteria:
- Patients who do not agree to participate and do not sign the informed consent.
- Patients undergoing concomitant surgery
- Patients undergoing surgery under anesthesia.
Sites / Locations
- Advanced Urogynecology of Michigan, P.C.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cough Test following Sling Surgery
Arm Description
All subjects enrolled will undergo sling surgery for treatment of stress urinary incontinence and subsequently asked to do a standing cough test.
Outcomes
Primary Outcome Measures
Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative cough test.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03120117
First Posted
April 14, 2017
Last Updated
April 18, 2017
Sponsor
Michigan Institution of Women's Health PC
1. Study Identification
Unique Protocol Identification Number
NCT03120117
Brief Title
Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures
Acronym
DISST
Official Title
Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan Institution of Women's Health PC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective study to assess the feasibility and success of performing an intra-operative standing cough test and the correlation with the long term success of the sling surgery.
Detailed Description
The goal is to seek correlation or disparity between the supine versus the sitting cough test, supine (lying down) versus standing cough test and sitting versus the standing cough test performed at a constant bladder volume; empty in the office and full in the operating room. Secondary objective is to test if the intra-operative standing cough test at fullness correlates with long term success of the sling surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Midurethral Slings
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cough Test following Sling Surgery
Arm Type
Experimental
Arm Description
All subjects enrolled will undergo sling surgery for treatment of stress urinary incontinence and subsequently asked to do a standing cough test.
Intervention Type
Procedure
Intervention Name(s)
Cough Test following Sling Surgery
Other Intervention Name(s)
DISST Procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative cough test.
Description
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.
Time Frame
Within first two years following sling procedure
Title
Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative MESA questionnaire.
Description
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.
Time Frame
Within first two years following sling procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who present with stress-dominant urinary incontinence
Patients who have undergone a stress test documentation both in the supine and standing/sitting position.
Patients who have completed child bearing.
Patients between 21 and 89 years of age.
Exclusion Criteria:
Patients who do not agree to participate and do not sign the informed consent.
Patients undergoing concomitant surgery
Patients undergoing surgery under anesthesia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salil Khandwala, MD
Organizational Affiliation
Michigan Institute of Women's Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Urogynecology of Michigan, P.C.
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures
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