Clinical trial NCT04817839: Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures
Official title: Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urinary Stress Incontinence
Keywords: post-operative physical restrictions
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2021-03-26
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in urogenital distress inventory (UDI) stress score
timeFrame: Baseline, 6 Months
Secondary outcomes:
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 6 months
measure: Incontinence Impact Questionnaire Short Form (IIQ-7)
timeFrame: 6 months
measure: Change in Patient Satisfaction Post-Operative Questionnaire
timeFrame: 6 weeks, 6 months, and 1 year
measure: Activity Assessment Scale (AAS)
timeFrame: 3 weeks
measure: Change in cough stress test
timeFrame: 6 months, 1 year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Oz Harmanli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: FitzGerald MP, Shisler S, Shott S, Brubaker L. Physical Limitations After Gynecologic Surgery, Journal of Pelvic Surgery: May-June 2001 - Volume 7 - Issue 3 - p 136-139