Outcomes of Limited Postoperative Restrictions Following Sling Placement: A Randomized Controlled Trial

NCT06840093 | Recruiting DMC

• 1 other identifier: 202407515
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Restriction; Midurethral Sling; Mesh; Stress Urinary Incontinence

Keywords

postoperative restrictions; midurethral sling; mesh; stress urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Urogenital Distress Inventory

  Questionnaire to assess the severity of lower urinary trat symptoms. Baseline compared to 3 months postoperatively with the hypothesis limited postoperative restrictions will result in non-inferior urinary symptoms compared to standard restrictions

  3 months and 1 year postoperatively

Secondary Outcomes (5)

• Incidence of adverse events

  Primarily 3 months, will offer 1 year survey follow up

• Self-reported activity

  2 weeks and 3 months postoperatively

• Post-operative pain scores

  2 weeks and 3 months postoperatively

• Changes to Sexual Function

  3 months and 1 year postoperatively

• Patient Impression of Improvement

  2 weeks, 3 months and 1 year postoperatively

Study Arms (2)

Limited Restrictions

EXPERIMENTAL

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.

Behavioral: Limited Restrictions

Standard Restrictions

ACTIVE COMPARATOR

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.

Behavioral: Standard Restrictions

Interventions

Limited Restrictions BEHAVIORAL

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.

Limited Restrictions

Standard Restrictions BEHAVIORAL

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).

Standard Restrictions

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Leanne Brechtel, MD

CONTACT

+1 319 356 2294; leanne-brechtel@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 21, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

US (1)