Postoperative Restrictions for Stress Urinary Incontinence

Overseen By Leanne Brechtel, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Iowa

Disqualifiers: Non-English, Incarcerated, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best post-surgery guidelines for patients undergoing a midurethral sling procedure, a treatment for stress urinary incontinence, which causes urine leakage during physical activity. Researchers will divide patients into two groups: one will adhere to standard restrictions, such as avoiding heavy lifting for six weeks, while the other will have limited activity restrictions. Participants will complete surveys at intervals to assess adherence to these guidelines and their impact on recovery. The trial seeks individuals undergoing a midurethral sling procedure without additional surgeries. As an unphased trial, it offers participants the chance to contribute to improving recovery guidelines for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that midurethral sling procedures, used to treat stress urinary incontinence, are generally safe. In past studies, most patients did not experience major issues after surgery. For example, one study found that 85.9% of patients had no problems at all. Some reported minor issues like trouble urinating or temporary discomfort, but serious problems were rare.

Another study found that allowing patients to be more active sooner after surgery did not lead to worse outcomes. In fact, these relaxed guidelines might even aid in easier recovery for some patients.

Overall, the midurethral sling procedure is usually well-tolerated, with most patients experiencing only minor side effects. This information should reassure those considering participation in trials related to this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Postoperative Restrictions for Stress Urinary Incontinence trial because it challenges traditional recovery guidelines with a more lenient approach. Unlike the standard restrictions that limit lifting and require complete pelvic rest for six weeks, the limited restrictions allow patients to resume normal activities as soon as they feel comfortable, with no weight-lifting limits and fewer activity restrictions. This trial could reveal that a less restrictive recovery protocol is just as effective, potentially improving patients' quality of life during recovery and reducing unnecessary limitations. If successful, these findings might revolutionize postoperative care for stress urinary incontinence, offering patients more freedom and faster return to normal life.

What evidence suggests that this trial's postoperative restrictions could be effective for stress urinary incontinence?

Research has shown that midurethral sling procedures for stress urinary incontinence are effective over the long term. One study found that 76.3% of patients experienced significant symptom improvement even 20-25 years post-procedure. In this trial, participants will join either a "Limited Restrictions" group or a "Standard Restrictions" group to assess postoperative recovery. Evidence suggests that fewer restrictions after surgery do not harm recovery and might even be beneficial. Patients who resumed normal activities sooner did not experience worse outcomes than those who adhered to stricter guidelines. Overall, sling surgeries are considered safe and effective, regardless of whether strict activity limits are followed post-surgery. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone a mesh urethral sling placement to treat stress urinary incontinence. Participants will be randomly assigned to follow either standard postoperative restrictions or limited restrictions and will complete surveys over the course of a year.

Inclusion Criteria

I am having a specific surgery for urinary incontinence using synthetic mesh.

Exclusion Criteria

I am undergoing a procedure for organ prolapse.

Non-English speaking

Incarcerated

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a midurethral sling procedure and are assigned to either limited or standard postoperative restrictions

6 weeks

1 visit (in-person) at 2 weeks post-surgery

Follow-up

Participants complete surveys and are monitored for safety and effectiveness at 2 weeks, 3 months, and 1 year postoperatively

1 year

3 visits (in-person or virtual) at 2 weeks, 3 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Limited Restrictions
• Standard Restrictions

Trial Overview The study aims to compare the outcomes of two different sets of postoperative instructions: one with standard activity and lifting limitations, and another with fewer restrictions following sling surgery for urinary incontinence.

How Is the Trial Designed?

Group I: Limited Restrictions Experimental Treatment 1 Intervention

Patients will receive a handout with the following instructions: After discharge from the hospital, resume your normal activities as soon as you feel comfortable. There is no weight limit on lifting. There are no specific activities you should avoid (other than pelvic rest as described below). We recommend pelvic rest, nothing in the vagina (no intercourse, hot tubs, tub bathing or swimming) for 2 weeks. If you are prescribed vaginal estrogen, you may restart usage 1 week after surgery. A physical exam will be performed at your two-week appointment to check how your incision is healing. If there are no complications noticed at this appointment, there are no further pelvic restrictions. You can resume all activities, including vaginal intercourse, as tolerated.

Group II: Standard Restrictions Active Control 1 Intervention

Patient will receive a handout with the following instructions: After discharge from the hospital, avoid doing any strenuous activity (any activity that requires so much exertion that you cannot have a conversation comfortably while doing it). Do not lift anything over 15 pounds for 6 weeks after surgery. For 6 weeks, we recommend complete pelvic rest, nothing in the vagina (no intercourse, hot tubs, tub bathing or swimming). If you are prescribed vaginal estrogen, you may restart usage 1 week after surgery. A physical exam will be performed at your two-week appointment to check how your incision is healing.

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10793800/

Long-term outcomes of surgical interventions for stress ... This study, with a median follow-up of 48 months, sheds light on the long-term effectiveness of surgeries for stress urinary incontinence, offering ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06840093/outcomes-of-limited-postoperative-restrictions-following-sling-placement-a-randomized-controlled-trial

Outcomes of Limited Postoperative Restrictions Following ... Emerging data indicate that these restrictions do not significantly influence short- or long-term outcomes and may even have detrimental effects ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0301211525003860

Long-term outcome of the retropubic TVT procedure for ... Retropubic TVT shows durable efficacy for stress urinary incontinence after 20–25 years. 76.3% of patients report significant long-term improvement in symptoms.

4. mdpi.com mdpi.com/2077-0383/14/10/3572

Long-Term Outcomes Associated with the Use of a Soft ... All patients were discharged within a few hours after surgery or on the following day. No significant intraoperative or early postoperative complications were ...

5. bmj.com bmj.com/content/365/bmj.l1842

Surgical interventions for women with stress urinary ... These statements also accept that MUS surgery for stress urinary incontinence is effective and safe in studies with up to one year of follow-up ...

6. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00343-8/fulltext

Long-term safety of mid-urethral sling for stress urinary ... In the 45 studies analyzed, the results were heterogeneous across studies: the rate of reoperation ranged from 0% to 19% at 5 years and 0%–17% ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12146218/

Evaluating Surgical Trends and Outcomes in Stress ... This retrospective audit aimed to evaluate surgical treatment patterns and outcomes for SUI at a district general hospital between 2018 and 2023