Effects of unrestricted exercise after mid-urethral sling surgery for urinary incontinence
IMpact of Unrestricted ACTIVity Following Mid-Urethral Sling Surgery (I'M ACTIVe): Quality of Life and Cost Implications
This study tests if letting women exercise normally right after mid-urethral sling surgery for urinary incontinence helps them recover better and feel happier in the long run compared to sticking to activity restrictions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Beverly Hills, California) |
| Trial ID | NCT02316275 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of allowing women to resume normal physical activity immediately after mid-urethral sling surgery for stress urinary incontinence. It aims to compare the outcomes of unrestricted postoperative activity versus standard activity restrictions on continence over the intermediate and long term. The research will assess whether immediate resumption of normal activities affects recovery and quality of life, potentially leading to changes in postoperative care guidelines.
Who should consider this trial
Good fit: Ideal candidates are non-pregnant women with self-reported stress urinary incontinence who are scheduled for mid-urethral sling surgery.
Not a fit: Patients who are under 18 years old, currently pregnant, or undergoing certain types of pelvic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery and quality of life for women undergoing surgery for stress urinary incontinence.
How similar studies have performed: Other studies have explored postoperative activity levels, but this specific approach to unrestricted activity following mid-urethral sling surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beverly Hills, California
- Cedars-Sinai Medical Center — Beverly Hills, California, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Anger, MD, MPH — Cedars-Sinai Medical Center
- Study coordinator: Jennifer Anger, MD, MPH
- Phone: 3103852992
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.