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Post-Operative Activity Restriction Duration for Stress Urinary Incontinence

N/A

Recruiting

Led By Oz Harmanli, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who are ambulatory and scheduled for midurethral sling placement surgery only for treatment of stress urinary incontinence

At least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 6 months, and 1 year

Awards & highlights

Study Summary

This trial will compare outcomes and satisfaction for patients who have different post-operative restrictions following a midurethral sling procedure.

Who is the study for?

This trial is for ambulatory patients at least 18 years old who are scheduled for midurethral sling surgery to treat stress urinary incontinence. Participants must be able to understand and complete study documents in English or Spanish, and commit to not lifting heavy objects (over 20 lbs) for 6 weeks.Check my eligibility

What is being tested?

The study compares two different durations of activity restrictions after midurethral sling surgery: one group will have a 3-week restriction, while the other will have a 6-week restriction. The focus is on postoperative outcomes and patient satisfaction.See study design

What are the potential side effects?

Since this trial involves post-surgical care instructions rather than medication, it does not directly test interventions with side effects. However, general surgical risks may include discomfort, infection risk at the incision site, or complications related to reduced activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk and am scheduled for a specific surgery to treat stress urinary incontinence.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 6 months, and 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 6 months, and 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 6 months, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in urogenital distress inventory (UDI) stress score

Secondary outcome measures

Activity Assessment Scale (AAS)

Change in Patient Satisfaction Post-Operative Questionnaire

Change in cough stress test

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: 6-week post-operative activity restrictionExperimental Treatment1 Intervention

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.

Group II: 3-week post-operative activity restrictionExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationIndustry Sponsor

719 Previous Clinical Trials

932,865 Total Patients Enrolled

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,738,008 Total Patients Enrolled

Oz Harmanli, MDPrincipal InvestigatorYale University

2 Previous Clinical Trials

137 Total Patients Enrolled

Media Library

3-week post-operative activity restriction Clinical Trial Eligibility Overview. Trial Name: NCT04817839 — N/A

Stress Incontinence Research Study Groups: 3-week post-operative activity restriction, 6-week post-operative activity restriction

Stress Incontinence Clinical Trial 2023: 3-week post-operative activity restriction Highlights & Side Effects. Trial Name: NCT04817839 — N/A

3-week post-operative activity restriction 2023 Treatment Timeline for Medical Study. Trial Name: NCT04817839 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant enrollment rate for this experiment?

"Affirmative, the information on clinicaltrials.gov implies that this trial is currently searching for participants. Originally posted in July 2021 and last edited in November of the same year, it seeks to find 205 volunteers across 1 site."

Answered by AI

Is this experiment currently recruiting participants?

"Per clinical trials.gov, this medical trial is presently enrolling participants. This research was initially posted on July 1st 2021 and has since been modified as of November 1st 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04817839.