Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures (DISST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Salil Khandwala MD, Michigan Institution of Women's Health PC

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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Procedure: Cough Test following Sling Surgery Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Michigan
Advanced Urogynecology of Michigan, P.C.
Dearborn, Michigan, United States, 48124
Sponsors and Collaborators
Michigan Institution of Women's Health PC
Investigators
Layout table for investigator information
Principal Investigator: Salil Khandwala, MD Michigan Institute of Women's Health
Layout table for additonal information
Responsible Party: Salil Khandwala MD, Medical Director, Michigan Institution of Women's Health PC
ClinicalTrials.gov Identifier: NCT03120117    
Other Study ID Numbers: MIWH13-001
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Salil Khandwala MD, Michigan Institution of Women's Health PC:
Midurethral Slings
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations