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

NCT ID: NCT03120117

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2018-01-31

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cough Test following Sling Surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

DISST Procedure

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Michigan Institution of Women's Health PC

OTHER

Sponsor Role: lead

Responsible Party

Salil Khandwala MD

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salil Khandwala, MD

Role: PRINCIPAL_INVESTIGATOR

Michigan Institute of Women's Health

Locations

Advanced Urogynecology of Michigan, P.C.

Dearborn, Michigan, United States

Countries

United States

Other Identifiers

MIWH13-001

Identifier Type: -

Identifier Source: org_study_id