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

Stress Urinary Incontinence Clinical Trial

— DISST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03120117
• Other study ID #: MIWH13-001
• Status: Active, not recruiting
• Phase: N/A
• First received: April 14, 2017
• Last updated: April 18, 2017
• Start date: August 2013
• Est. completion date: January 2018

Study information

• Verified date: April 2017
• Source: Michigan Institution of Women's Health PC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 87
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Advanced Urogynecology of Michigan, P.C.	Dearborn	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan Institution of Women's Health PC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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