Evaluating postoperative activity restrictions after midurethral sling placement
Outcomes of Limited Postoperative Restrictions Following Sling Placement: A Randomized Controlled Trial
This study is testing whether patients who have had a midurethral sling procedure for stress urinary incontinence do better with strict activity limits or no limits after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06840093 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the optimal postoperative restrictions for patients who have undergone a midurethral sling procedure for stress urinary incontinence. Participants will be randomly assigned to either a standard restrictions group, which limits activity and lifting for six weeks, or a limited restrictions group with no activity limitations. Surveys will be administered at 2 weeks, 3 months, and 1 year post-surgery to assess adherence to restrictions and differences in surgical outcomes. The study seeks to address the variability in postoperative counseling and provide evidence-based recommendations for patient care.
Who should consider this trial
Good fit: Ideal candidates are individuals undergoing isolated synthetic mesh retropubic midurethral sling placement for stress urinary incontinence.
Not a fit: Patients who are non-English speaking, incarcerated, or have cognitive impairments that prevent informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more flexible postoperative activity guidelines, improving recovery and quality of life for patients.
How similar studies have performed: Previous studies have shown success with limited postoperative restrictions in similar surgical contexts, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: Undergoing isolated synthetic mesh retropubic midurethral sling placement Exclusion criteria: Non-English speaking, incarcerated, cognitive impairment precluding informed consent, unable to ambulate without the assistance of an ambulation device, concurrent prolapse procedure
Where this trial is running
Iowa City, Iowa
- University of Iowa Health Care — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Study coordinator: Leanne Brechtel, MD
- Email: leanne-brechtel@uiowa.edu
- Phone: +1 319 356 2294
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.