Exercise After Mid-Urethral Sling Surgery for Stress Urinary Incontinence

Overseen By Jennifer Anger, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Age <18, Non-English speakers, others

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

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different activity levels after mid-urethral sling surgery affect long-term outcomes for women with stress urinary incontinence. One group will follow standard advice to rest for six weeks, while another will resume usual activities immediately. Women with stress urinary incontinence planning to undergo this surgery may be suitable candidates. Participants should be available for follow-up over two years and able to complete study assessments. As an unphased trial, this study allows participants to contribute to valuable research that could enhance 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. Please consult with the study team or your doctor for guidance.

What prior data suggests that unrestricted post-operative activity is safe after mid-urethral sling surgery?

Research shows that for women who have had mid-urethral sling surgery, studies have examined the effects of activity restrictions post-surgery. One study found that limiting activities does not significantly impact recovery or long-term outcomes. Another study suggested that allowing patients to resume normal activities immediately after surgery does not increase complications. In fact, some findings indicate that avoiding strict activity limits might be beneficial in certain cases. Importantly, these studies have not reported major safety concerns with either approach. Thus, whether patients have activity restrictions or not, research suggests both options are generally safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it challenges the traditional post-operative approach for stress urinary incontinence. Typically, patients face six weeks of activity restrictions to ensure proper recovery after mid-urethral sling surgery. However, this trial is exploring the possibility of allowing patients to resume regular activities immediately. This could potentially lead to faster recovery times and improved quality of life, without compromising surgical outcomes. Finding out whether activity restrictions are necessary could reshape post-surgery care, offering more freedom to patients.

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

This trial will compare two approaches to post-operative care after mid-urethral sling surgery for stress urinary incontinence. One group of participants will follow standard post-operative activity restrictions, limiting activities for six weeks. Another group will have no post-operative activity restrictions and will resume regular activities immediately after surgery. Research has shown that returning to normal activities soon after mid-urethral sling surgery can enhance patient satisfaction with recovery. Specifically, one study found that individuals who resumed their usual routines three weeks after surgery felt more satisfied six months later than those who waited longer. Another study found that limiting activities can negatively affect patient satisfaction. The main point is that resuming daily life sooner may improve women's satisfaction with their recovery after surgery. ^{1 4 6 7 8}

Who Is on the Research Team?

Jennifer Anger, MD, MPH

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for non-pregnant women with stress urinary incontinence who are planning to have mid-urethral sling surgery. They must be able to follow up for 2 years, complete study tasks, and provide consent. Women under 18, currently pregnant or less than a year post-partum, or unable to understand English can't join.

Inclusion Criteria

You have trouble controlling your bladder, as shown by a physical exam or a special test.

Available for 2 years of follow-up

I am not pregnant.

Exclusion Criteria

I am having or have had surgery for prolapse, but not anterior colporrhaphy.

Currently pregnant or <12 months post-partum

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo mid-urethral sling surgery and begin initial recovery

1 week

1 visit (in-person)

Post-operative Activity Phase

Participants either follow standard post-operative activity restrictions or resume regular activity immediately

6 weeks

Weekly questionnaire assessments

Follow-up

Participants are monitored for continence outcomes and quality of life improvements

2 years

What Are the Treatments Tested in This Trial?

Interventions

• No post-operative activity restrictions
• Standard post-operative activity restriction

Trial Overview The study is testing the effects of not restricting activities after mid-urethral sling surgery against standard activity restrictions. It aims to see how this affects continence outcomes over time and when patients naturally return to their usual activities.

How Is the Trial Designed?

Group I: No post-operative activity restrictions Experimental Treatment 1 Intervention

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

Group II: Standard post-operative activity restriction Active Control 1 Intervention

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

No post-operative activity restrictions is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Mid-Urethral Sling for:

• Stress Urinary Incontinence

Approved in United States as Mid-Urethral Sling for:

• Stress Urinary Incontinence

Approved in Canada as Mid-Urethral Sling for:

• Stress Urinary Incontinence

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

Voiding dysfunction after mid-urethral sling procedures can occur, but a new method allows for adjustment of the sling under local anesthesia to alleviate this issue.

In a case study of two women who experienced postoperative voiding difficulty, loosening the mesh through the vaginal incision led to immediate symptom resolution while preserving urinary continence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of voiding dysfunction after transobturator tape procedure. Ozel, B., Minaglia, S., Hurtado, E., et al.[2004]

In a study of 88 women undergoing sub-urethral sling procedures for urinary stress incontinence, the transobturator route (TOR) resulted in significantly lower pain scores compared to the retropubic route (RPR).

While both procedures had similar immediate functional outcomes, the RPR route was associated with a higher frequency of bladder injuries, whereas the TOR route had more vaginal injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peri-operative complications and pain after the suburethral sling procedure for urinary stress incontinence: a French prospective randomised multicentre study comparing the retropubic and transobturator routes. David-Montefiore, E., Frobert, JL., Grisard-Anaf, M., et al.[2006]

In a study of 90 women with stress urinary incontinence who underwent midurethral sling surgery, there was a significant increase in leisure physical activity levels postoperatively, with the percentage of women achieving sufficient activity rising from 44% to 54%.

Improvements in urinary symptoms were linked to better physical functioning scores, indicating that successful treatment of incontinence can enhance overall physical activity and quality of life for these women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in physical activity and functioning after undergoing midurethral sling procedure for urinary incontinence. Sung, VW., Kassis, N., Raker, CA.[2021]

Urethral obstruction is a common complication following mid-urethral synthetic sling surgery for female stress urinary incontinence, and identifying patients at risk for this issue is crucial for effective management.

The study highlights the importance of using urodynamics and translabial ultrasound to diagnose and understand the anatomical reasons for sling obstruction, which can improve patient outcomes post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outlet obstruction after sling surgery. Tse, V., Chan, L.[2011]

After 5 years, women with retropubic slings had a slightly higher treatment success rate (51.3%) compared to those with transobturator slings (43.4%), but this difference did not meet the criteria for equivalence, indicating that both options have diminishing effectiveness over time.

Despite a decrease in treatment success, overall satisfaction remained high for both sling types, with women using transobturator slings reporting better urinary symptoms and sexual function improvements compared to those with retropubic slings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5-year longitudinal followup after retropubic and transobturator mid urethral slings. Kenton, K., Stoddard, AM., Zyczynski, H., et al.[2022]

In a meta-analysis of 28 studies involving 2,607 patients, retropubic tension-free vaginal tape showed significantly higher objective and subjective cure rates for stress urinary incontinence compared to transobturator tension-free vaginal tape, particularly in patients with risk factors like obesity and intrinsic sphincter deficiency.

Both techniques had similar overall complication rates, indicating that while retropubic tape is more effective, it does not come with increased risks compared to the transobturator method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retropubic versus Transobturator Mid Urethral Slings in Patients at High Risk for Recurrent Stress Incontinence: A Systematic Review and Meta-Analysis. Kim, A., Kim, MS., Park, YJ., et al.[2019]

In a multicenter randomized controlled trial involving 149 women, both the retropubic (TVT) and transobturator (TVT-O) mid-urethral sling procedures showed similar functional outcomes and improvements in quality of life over a 24-month follow-up period.

Both procedures resulted in significant improvements in sexual satisfaction, with no notable differences between the two groups, indicating that either option is effective for treating urinary incontinence without compromising sexual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Functional results following transobturator and retropubic mid-urethral sling]. Trichot, C., Salet-Lizee, D., Descamps, P., et al.[2014]

Retropubic mid urethral slings were found to be more effective than transobturator slings in treating female stress urinary incontinence, showing better objective and subjective cure rates based on a systematic review of randomized controlled trials.

However, retropubic slings had a higher risk of complications such as bladder perforations and bleeding, while transobturator slings were associated with more neurological symptoms and vaginal perforations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the performance of retropubic mid urethral slings versus transobturator mid urethral slings. Seklehner, S., Laudano, MA., Xie, D., et al.[2022]

In a study of 351 women who underwent midurethral sling (MUS) surgery, those who engaged in higher levels of strenuous exercise (≥90 minutes per week) reported significantly lower rates of stress urinary incontinence (SUI) symptoms two years post-surgery (12.8% vs 26.6%).

The findings suggest that maintaining a higher level of physical activity after MUS surgery may be beneficial in reducing the likelihood of experiencing SUI symptoms, highlighting the importance of postoperative exercise in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Women Who Self-report More Exercise Have Increased Rates of Symptomatic Stress Urinary Incontinence After Midurethral Slings? Ferrante, KL., Gantz, MG., Sridhar, A., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38710013/

Postoperative Activity Restrictions After Slings The objective of this study was to evaluate the effect of postoperative activity restriction on satisfaction and outcomes after slings.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40105744/

Activity Restrictions After Midurethral Sling: A Randomized ... Return to normal activities 3 weeks after MUS surgery resulted in significantly higher satisfaction scores at 6 months compared to a 6-week restriction.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1028455924002298

Predictors and outcomes of Mid-urethral sling continence ... In this review we collated published data on MUS surgery performed among Taiwanese women with SUI in search for the best techniques and its outcome.

4. urotoday.com urotoday.com/component/content/category/1131-urotoday/1151-stress-incontinence.html?Itemid=815&layout=blog&start=100

Stress Incontinence - Results from #100 Postoperative activity restrictions can affect patient satisfaction after midurethral sling (MUS) surgery. The aim of the study was to assess ...

5. clinicaltrial.be clinicaltrial.be/en/details/74452?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Impact of Unrestrictive Exercise Following Mid-Urethral S... Patients are to resume regular activity immediately after mid-urethral sling surgery. The investigators will determine the impact of ...

6. journals.lww.com journals.lww.com/fpmrs/fulltext/2025/06000/postoperative_activity_restrictions_after_slings_.11.aspx

Postoperative Activity Restrictions After Slings Although there may be some immediate symptom relief after midurethral sling surgery, continued improvement may be seen up to 12 weeks postoperatively. In ...

7. withpower.com withpower.com/trial/phase-urinary-incontinence-stress-11-2011-3d7bf

Exercise After Mid-Urethral Sling Surgery for Stress Urinary ... This treatment is unique because it involves no post-operative activity restrictions, allowing patients to resume normal physical activities sooner, which may ...

8. 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 ...