NCT04552457

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration 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

Study Start

First participant enrolled

August 7, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

September 10, 2020

Last Update Submit

February 2, 2023

Conditions

Stress Urinary IncontinencePatient SatisfactionSurgery

Keywords

Mid-urethral slingPostoperative activityActivity restriction

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction with postoperative course

    5-point scale with minimum of 1 and maximum of 5 points, higher scores corresponding to more satisfaction

    6 months

Secondary Outcomes (1)

  • Surgical success

    6 months

Study Arms (2)

No activity restrictions

EXPERIMENTAL
Behavioral: No activity restrictions

Activity restrictions

ACTIVE COMPARATOR
Behavioral: Activity restrictions

Interventions

No activity restrictionsBEHAVIORAL

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

No activity restrictions
Activity restrictionsBEHAVIORAL

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.

Activity restrictions

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-85 years
  • Urodynamic-proven stress incontinence or stress leakage on physical exam
  • Desires surgical management for stress incontinence with a midurethral sling

You may not qualify if:

  • Prior midurethral sling or urethropexy
  • Prior pelvic reconstruction
  • Prior pelvic radiation
  • Connective tissue disorder
  • Severe physical limitation at baseline
  • Currently pregnant or desires future childbearing potential
  • Concomitant surgeries (except for anterior colporrhaphy for anterior wall prolapse less than 0 on POPQ or other minor procedures).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Shore University Hospital

Great Neck, New York, 11030, United States

Location

Related Publications (9)

  • Gephart LF, Doersch KM, Reyes M, Kuehl TJ, Danford JM. Intraabdominal pressure in women during CrossFit exercises and the effect of age and parity. Proc (Bayl Univ Med Cent). 2018 Apr 9;31(3):289-293. doi: 10.1080/08998280.2018.1446888. eCollection 2018 Jul.

    PMID: 29904290BACKGROUND

  • Mueller MG, Lewicky-Gaupp C, Collins SA, Abernethy MG, Alverdy A, Kenton K. Activity Restriction Recommendations and Outcomes After Reconstructive Pelvic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Apr;129(4):608-614. doi: 10.1097/AOG.0000000000001924.

    PMID: 28277355BACKGROUND

  • Weir LF, Nygaard IE, Wilken J, Brandt D, Janz KF. Postoperative activity restrictions: any evidence? Obstet Gynecol. 2006 Feb;107(2 Pt 1):305-9. doi: 10.1097/01.AOG.0000197069.57873.d6.

    PMID: 16449116BACKGROUND

  • McCormack R, Bovard J. Early functional rehabilitation or cast immobilisation for the postoperative management of acute Achilles tendon rupture? A systematic review and meta-analysis of randomised controlled trials. Br J Sports Med. 2015 Oct;49(20):1329-35. doi: 10.1136/bjsports-2015-094935. Epub 2015 Aug 17.

    PMID: 26281836BACKGROUND

  • Nygaard IE, Hamad NM, Shaw JM. Activity restrictions after gynecologic surgery: is there evidence? Int Urogynecol J. 2013 May;24(5):719-24. doi: 10.1007/s00192-012-2026-2. Epub 2013 Jan 23.

    PMID: 23340879BACKGROUND

  • FitzGerald MP, S. S., Shott S, Brubaker L (2001).

    BACKGROUND

  • Magon N, Kalra B, Malik S, Chauhan M. Stress urinary incontinence: What, when, why, and then what? J Midlife Health. 2011 Jul;2(2):57-64. doi: 10.4103/0976-7800.92525.

    PMID: 22408333BACKGROUND

  • Murphy M. Restrictions and limitations after pelvic floor surgery: what's the evidence? Curr Opin Obstet Gynecol. 2017 Oct;29(5):349-353. doi: 10.1097/GCO.0000000000000393.

    PMID: 28719393BACKGROUND

  • Lai E, McDonald K, Chopra V, Robinson L, Alvarez A, O'Shaughnessy D, Pillalamarri N, Polland A, Shalom D, Winkler H. Postoperative Activity Restrictions After Slings: A Randomized Controlled Trial. Urogynecology (Phila). 2025 Jun 1;31(6):619-626. doi: 10.1097/SPV.0000000000001515. Epub 2024 May 6.

    PMID: 38710013DERIVED

MeSH Terms

Conditions

Urinary Incontinence, StressPatient Satisfaction

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 SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 17, 2020

Study Start

August 7, 2020

Primary Completion

November 30, 2022

Study Completion

January 20, 2023

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations

US(1)