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Postoperative Activity Restrictions After Slings

NCT04552457 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2023-02-03

No results posted yet for this study

Summary

Postoperative restrictions are often based on expert opinion and "common sense". There is a wide variety in the recommended activity limitation amongst pelvic floor surgeons. Many patients undergo urogynecologic procedures to improve their quality of life, and these additional restrictions decrease their quality of life in the short term. Our hypothesis is that unrestricted activity after a mid-urethral sling will not negatively impact a patient's recovery or likelihood of surgical success.

Eligible participants will be randomized to no postoperative instructions or traditional postoperative instructions. Patients will be followed up at 2 weeks, 6 weeks, and 6 months postoperatively. Data will be collected throughout the follow up period, but the primary endpoint is at 6 months. At the 6 month visit, subjects' activity level, leakage symptoms, and postoperative satisfaction will be assessed.

Conditions

  • Stress Urinary Incontinence
  • Patient Satisfaction
  • Surgery

Interventions

BEHAVIORAL

No activity restrictions

Patients in the "No activity restrictions" group will be allowed to return to their normal activity immediately.

BEHAVIORAL

Activity restrictions

Patients in the "Activity restrictions" group will not be allowed to perform strenuous exercise or lift anything greater than 10lbs. "Strenuous exercise" will be defined as is any activity that requires so much exertion that one cannot have a conversation comfortably while doing it.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2022-11-30
Completion
2023-01-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04552457 on ClinicalTrials.gov