NCT04817839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2024

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

March 23, 2021

Last Update Submit

February 2, 2026

Conditions

Urinary Stress Incontinence

Keywords

post-operative physical restrictions

Outcome Measures

Primary Outcomes (1)

  • Change in urogenital distress inventory (UDI) stress score

    UDI form calculator assesses life quality and symptom distress in women suffering from urinary incontinence. The range is 0 to 70, higher means worse, lowers means better (higher is more symptoms.

    Baseline, 6 Months

Secondary Outcomes (5)

  • Patient Global Impression of Improvement (PGI-I)

    6 months

  • Incontinence Impact Questionnaire Short Form (IIQ-7)

    6 months

  • Change in Patient Satisfaction Post-Operative Questionnaire

    6 weeks, 6 months, and 1 year

  • Activity Assessment Scale (AAS)

    3 weeks

  • Change in cough stress test

    6 months, 1 year

Study Arms (2)

3-week post-operative activity restriction

EXPERIMENTAL

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.

Behavioral: 3-week post-operative activity restriction

6-week post-operative activity restriction

EXPERIMENTAL

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.

Behavioral: 6-week post-operative activity restriction

Interventions

3-week post-operative activity restrictionBEHAVIORAL

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.

3-week post-operative activity restriction
6-week post-operative activity restrictionBEHAVIORAL

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.

6-week post-operative activity restriction

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Oz Harmanli, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 26, 2021

Study Start

July 1, 2021

Primary Completion

April 5, 2024

Study Completion

December 16, 2024

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

US(1)