Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures

Yale University

Status: Active, not recruiting

Conditions: Urinary Stress Incontinence

Treatments: Behavioral: 3-week post-operative activity restriction; Behavioral: 6-week post-operative activity restriction

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04817839

2000029067

000

Details and patient eligibility

About

The purpose of this study is to compare postoperative outcomes and patient satisfaction between 3 and 6-week postoperative restrictions after a midurethral sling procedure.

Full description

This is a blinded, randomized controlled trial. Patients undergoing midurethral sling placement for stress urinary incontinence will be asked to participate in the study. If eligible and willing to participate, patients will be randomized to a "3 weeks post-operative restriction" or "6-week post-operative restriction" of activities group.

Currently, pelvic surgeons' recommendations for activity and lifting restrictions during post-operative period vary widely from 1 to 50 pounds (10). Given variation in literature and reasonable expectations for lifting restrictions, 20-pound lifting restriction was considered to be a reasonable and attainable expectation from patients. Both groups will be given an identical set of postoperative instructions which include refrainment from lifting anything over 20 pounds, avoid strenuous exercise, running, or perform high-impact aerobic activities during the restricted activity period. Depending on their random allocation, patients will follow these instructions either for 3 or 6 postoperative weeks. The activities which all patients will be allowed to do during their postoperative recovery include walking, using stairs and showering in both groups. All patient will be asked to refrain from sexual intercourse for 6 weeks consistent with current routine post op recommendations (6). Other than the time of activity restriction post op (heavy lifting, strenuous exercise, running, high impact exercise), patients will receive identical postoperative instructions otherwise.

Enrollment: 205 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age,
• Patients who are ambulatory and scheduled for midurethral sling placement surgery only for treatment of stress urinary incontinence

Exclusion criteria

• • Patients who are unable to read, understand, or complete study documents in English or Spanish

  • Patient undergoing concomitant surgery for pelvic organ prolapse other than midurethral sling
  • Patients who are unable to commit to 6 weeks of no heavy lifting (20 lbs)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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205 participants in 2 patient groups

3-week post-operative activity restriction

Experimental group

Description:

Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 3-weeks post operation.

Treatment:

Behavioral: 3-week post-operative activity restriction

6-week post-operative activity restriction

Experimental group

Description:

Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 6-weeks post operation.

Treatment:

Behavioral: 6-week post-operative activity restriction