Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Stress Urinary Incontinence

Treatments: Other: No post-operative activity restrictions; Other: Standard post-operative activity restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT02316275

Pro00026474

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Standard post-operative activity restriction

Active Comparator group

Description:

As a traditional method, patients will be restricted from activity for six weeks after sling surgery.

Treatment:

Other: Standard post-operative activity restriction

No post-operative activity restrictions

Experimental group

Description:

Patients are to resume regular activity immediately after mid-urethral sling surgery.

Treatment:

Other: No post-operative activity restrictions