Recruiting

Exercise

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT02316275

Conditions

Stress Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No post-operative activity restrictions

Standard post-operative activity restriction

Study Details

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.

Conditions

Stress Urinary Incontinence

Study ID

NCT02316275

Start date

Dec, 2011

Status verified date

Jul, 2018

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard post-operative activity restriction

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

experimental: No post-operative activity restrictions

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

Interventions

No post-operative activity restrictions

Patients are to resume regular activity immediately after mid-urethral sling surgery. The investigators will determine the impact of unrestricted post-operative activity on continence outcomes of mid-urethral sling surgery in women with stress urinary incontinence (SUI). Investigators will measure the effect of unrestricted post-operative activity on early health-related quality of life (HRQOL). A Productivity Loss form for cost-effective analysis will be asked of the patient.

Standard post-operative activity restriction

Primary outcome measure

  • Unrestricted postoperative physical activity for surgical outcomes measure by questionnaire assessment. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Jennifer Anger, MD, MPH

3103852992

Locations

Cedars-Sinai Medical Center

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Jennifer Anger, MD, MPH

310-385-2992

Principal Investigator:

Jennifer Anger, MD, MPH

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Jul 18, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2018-07-18.