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

NCT03120117 | Unknown

• 1 other identifier: MIWH13-001
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

Midurethral Slings

Outcome Measures

Primary Outcomes (2)

• 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.

  Within first two years following sling procedure

• 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.

  Within first two years following sling procedure

Study Arms (1)

Cough Test following Sling Surgery

EXPERIMENTAL

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

Interventions

Cough Test following Sling Surgery 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.

Also known as: DISST Procedure

Cough Test following Sling Surgery

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who do not agree to participate and do not sign the informed consent.
• Patients undergoing concomitant surgery
• Patients undergoing surgery under anesthesia.

Sponsors & Collaborators

• Michigan Institution of Women's Health PC: lead

Study Sites (1)

Advanced Urogynecology of Michigan, P.C.

Dearborn, Michigan, 48124, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Salil Khandwala, MD

  Michigan Institute of Women's Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 19, 2017
• Study Start: August 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: April 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)