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

Trial Summary

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 data supports the effectiveness of this treatment for stress urinary incontinence?

Research shows that mid-urethral sling procedures, including retropubic and transobturator slings, are effective in treating stress urinary incontinence, with improvements in physical activity and functioning reported after the procedure. Additionally, adjustments to the sling can resolve postoperative issues while maintaining continence. ^{1 2 3 4 5}

Is exercise after mid-urethral sling surgery safe?

Mid-urethral sling surgery for stress urinary incontinence is generally safe, but some patients may experience complications like voiding difficulties (trouble urinating) or urethral obstruction (blockage). These issues can often be resolved with adjustments to the sling, and most patients maintain urinary continence after such adjustments. ^{1 5 6 7 8}

How does the treatment of no post-operative activity restrictions after mid-urethral sling surgery differ from other treatments for stress urinary incontinence?

This treatment is unique because it involves no post-operative activity restrictions, allowing patients to resume normal physical activities sooner, which may improve physical functioning and activity levels compared to standard post-operative care that typically includes activity limitations. ^{1 2 3 5 9}

What is the purpose of this trial?

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.

Research Team

Jennifer Anger, MD, MPH

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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 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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Functional results following transobturator and retropubic mid-urethral sling]. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

A meta-analysis of the performance of retropubic mid urethral slings versus transobturator mid urethral slings. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Improvements in physical activity and functioning after undergoing midurethral sling procedure for urinary incontinence. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

5-year longitudinal followup after retropubic and transobturator mid urethral slings. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of voiding dysfunction after transobturator tape procedure. [2004]

6. United States 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. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Outlet obstruction after sling surgery. [2011]

8. Switzerland 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. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

Do Women Who Self-report More Exercise Have Increased Rates of Symptomatic Stress Urinary Incontinence After Midurethral Slings? [2023]