Recruiting

Sling Placement

Sponsor:

University of Iowa

Code:

NCT06840093

Conditions

Postoperative Restriction

Midurethral Sling

Mesh

Stress Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Limited Restrictions

Standard Restrictions

Study Details

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

Study ID

NCT06840093

Start date

Mar 1, 2025

Status verified date

Mar, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion: Undergoing isolated synthetic mesh retropubic midurethral sling placement Exclusion criteria: Non-English speaking, incarcerated, cognitive impairment precluding informed consent, unable to ambulate without the assistance of an ambulation device, concurrent prolapse procedure

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Limited Restrictions

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.

active comparator: Standard Restrictions

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.

Interventions

Limited Restrictions

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.

Standard Restrictions

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).

Primary outcome measure

  • Urogenital Distress Inventory [ Time Frame: 3 months and 1 year postoperatively ]

Central Contacts and Locations

Central contacts

Leanne Brechtel, MD

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

Locations

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Leanne E Urogynecology Fellow, MD

716-480-8583leanne-brechtel@uiowa.edu

Joseph Kowalski, MD

joseph-kowalski@uiowa.edu

Principal Investigator:

Leanne E Brechtel, MD

More Information

Sponsor

University of Iowa

Last update posted

Apr 1, 2025

Last verified

Mar, 2025

Keywords

  • postoperative restrictions
  • midurethral sling
  • mesh
  • stress urinary incontinence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Iowa on 2025-04-01.