Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery

Not Applicable

Recruiting

• Conditions: Stress Urinary Incontinence
• Interventions: Other: No post-operative activity restrictions; Other: Standard post-operative activity restriction

• Registration Number: NCT02316275
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

To determine the impact of unrestricted postoperative activity on intermediate- and long-term continence outcomes of mid-urethral sling surgery in women with stress urinary incontinence.

To assess the natural return to baseline activity level when patients are unrestricted following mid-urethral sling surgery with or without concomitant anterior or posterior pelvic organ prolapse repair.

Detailed Description

Over the last decade, the mid-urethral sling has become the new gold standard in the management of stress urinary incontinence because of its high success rate and minimally invasive nature. However, postoperative management has not kept pace with the modernization of sling surgery. Although formal guidelines regarding the resumption of normal activity levels have not been established, it is general practice to restrict exercise for a minimum of six weeks after surgery.

For the study, if immediate resumption of normal activity has no impact on intermediate- and long-term continence outcomes, it may result in improved quality of life and cost savings from a societal perspective.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18
• Primary Completion: 2021-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Non-pregnant female
• Self-reported stress urinary incontinence
• Incontinence demonstrated on physical exam and/or by an urodynamics study
• Planned mid-urethral sling surgery
• Available for 2 years of follow-up
• Willing and able to complete study assessments per the judgment of the treating clinician
• Willing and able to provide written informed consent

Exclusion Criteria

• Age <18 years at time of enrollment
• Concomitant prolapse surgery other than anterior colporrhaphy
• Currently pregnant or <12 months post-partum
• Unable to read, write, or comprehend English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No post-operative activity restrictions	No post-operative activity restrictions	Patients are to resume regular activity immediately after mid-urethral sling surgery.
Standard post-operative activity restriction	Standard post-operative activity restriction	As a traditional method, patients will be restricted from activity for six weeks after sling surgery.

Primary Outcome Measures

Name	Time	Method
Unrestricted postoperative physical activity for surgical outcomes measure by questionnaire assessment.	2 years	Return to normal activity immediately after mid-urethral sling surgery could result in faster return to baseline health-related quality of life. Each questionnaire will be administered weekly following surgery until the patient returns to within 10% of baseline scores. Cost-effectiveness of early return to normal activity via Productivity Loss form as time spent recovering from surgery will be analyzed (incremental cost effectiveness ratio of net means by comparing the unrestricted and restricted groups).

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Beverly Hills, California, United States