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

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.

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

The Mini-Arc treatment for stress urinary incontinence showed that over 80% of patients reported significant improvement and satisfaction with their condition at a long-term follow-up, indicating its effectiveness in treating this condition. ^{1 2 3 4 5}

Is the treatment for stress urinary incontinence generally safe?

Research shows that surgical procedures for stress urinary incontinence, like vaginal mesh, have some risks. Complication rates within 5 years can be around 9.8%, with higher risks in the first 2 years, but most complications are identified early. ^{6 7 8 9 10}

How does the Limited Restrictions treatment for stress urinary incontinence differ from other treatments?

The Limited Restrictions treatment for stress urinary incontinence is unique because it focuses on postoperative care, potentially allowing for fewer activity limitations after surgery compared to standard restrictions. This approach may help patients recover more comfortably and quickly, although the specific details of how it differs from other treatments are not fully detailed in the available research. ^{1 6 11 12 13}

What is the purpose of this trial?

The purpose of this research study is to better understand optimal restrictions for patients postoperatively following a mesh urethral sling placement for patients with stress urinary incontinence. Patients undergoing a midurethral sling procedure will be assigned to one of two groups. One group with be given standard postprocedural restrictions including instructions to avoid moderate activity and no lifting over 15lbs for six weeks after surgery. The other group will have fewer restrictions, with no restrictions on activity or lifting. Participants will complete surveys at 2 weeks, 3 months and 1 year following their procedure to help providers better understand how patients are following postoperative restrictions and if there were any differences in the outcome of the procedure between the two groups.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Maintaining standards for surgery for female urinary incontinence. [2010]

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

Unilateral and bilateral bladder neck suspension (modified Pereyra) operation for stress urinary incontinence. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Voiding trial outcome following pelvic floor repair without incontinence procedures. [2018]

4. Egypt pubmed.ncbi.nlm.nih.gov

Mini-arc for the treatment of female stress urinary incontinence: long-term prospective evaluation by patient reported outcomes. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

How do you define success in stress urinary incontinence treatment? [2023]

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

Perioperative Adverse Events for Stress Urinary Incontinence Surgery: A National Analysis. [2021]

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

Transobturator tapes for stress urinary incontinence: Results of the Austrian registry. [2015]

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

Prospective study of a single-incision sling versus a transobturator sling in women with stress urinary incontinence: 3-year results. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Could the National Institute for Health and Clinical Excellence guidelines on urodynamics in urinary incontinence put some women at risk of a bad outcome from stress incontinence surgery? [2022]

11. Egypt pubmed.ncbi.nlm.nih.gov

Intravesical tension-free vaginal tape removal: is there a single solution? [2021]

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

Feasibility of measuring urethral pressure during female midurethral slings: Case report. [2022]

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

Office based criteria for predicting type II stress incontinence without further evaluation studies. [2015]