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NCT Number: NCT02316275

Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Beverly Hills, California, 90211, United States

Location status: Recruiting

Location contact

Jennifer Anger, MD, MPH

CONTACT

310-385-2992

Jennifer Anger, MD, MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No post-operative activity restrictions

Other

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

Other

Primary outcomes

  1. Unrestricted postoperative physical activity for surgical outcomes measure by questionnaire assessment.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Anger, MD, MPH

CONTACT

3103852992

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

IMpact of Unrestricted ACTIVity Following Mid-Urethral Sling Surgery (I'M ACTIVe): Quality of Life and Cost Implications

Important dates

Study start
2011
Primary completion
2021
Study completion
2031
First posted
Dec 12, 2014
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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