Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse

NCT04329715 | Completed

• 1 other identifier: Pro00104389
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the EVeRLAST study is to determine whether expedited resumption of postoperative activity levels is non-inferior to standard activity restrictions with respect to short-term anatomic prolapse outcomes. We hypothesize that immediate resumption of physical activities as tolerated will result in noninferior surgical outcomes following prolapse surgery when compared to standard postoperative activity restrictions. Participants will be enrolled and randomized at their preoperative clinic visit to one of two treatment arms: Arm 1: Standard instructions (no heavy lifting over 10lbs for 6 weeks; return to work at 4 weeks for sedentary work and 6 weeks for manual labor) Arm 2: Liberal instructions (no restrictions; resume activities and work as soon as able) We will also collect subjective and objective measures of pre- and postoperative physical activity, through the use of patient-reported physical activity assessments and wrist-worn accelerometers. Accelerometer data will be collected at the preoperative, 2-week-postoperative, and 6-week-postoperative time points. Accelerometer data will also be used to calculate time to resumption of normal activities, defined as time at which a patient resumes greater than 90% of her baseline preoperative level of physical activity. We will additionally be collecting data on relevant patient-reported outcomes of pelvic floor symptom severity, health-related quality of life measures, postoperative pain, time to return to work (where relevant), and patient global impression of improvement. Postoperative anatomic assessments will be performed at 6 weeks and 3 months postoperatively by blinded study personnel

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• Maximum support loss "SLMax"

  Most distal point of pelvic organ support (in centimeters) based on Pelvic Organ Prolapse Quantification system

  3 months

• Prolapse symptoms

  Pelvic Organ Prolapse Distress Inventory (POPDI) at 3 months

  3 months

Secondary Outcomes (11)

• Recovery time

  6 weeks

• Health related quality of life (HRQOL)

  3 months

• Physical function

  3 months

• Physical function

  3 months

• Time to return to work

  3 months

Study Arms (2)

Expedited instructions

EXPERIMENTAL

Behavioral: Expedited postoperative activity instructions

Restricted instructions

ACTIVE COMPARATOR

Behavioral: Standard postoperative activity restructions

Interventions

Expedited postoperative activity instructions BEHAVIORAL

Ad lib postoperative activity and return to work recommendations

Expedited instructions

Standard postoperative activity restructions BEHAVIORAL

Standard conservative postoperative activity and return to work recommendations

Restricted instructions

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage II-IV pelvic organ prolapse
• Bothersome bulge symptoms
• At least 725 MET-minutes/week on International Physical Activity Questionnaire Short Form
• English-speaking
• Undergoing treatment of prolapse
• Surgery occurring at least 7 days from date of randomization (to allow for collection of at least 7 days of preoperative accelerometer data)
• Able and willing to follow up at 3 months for in-office exam

You may not qualify if:

• Enrollment in another research study of pelvic organ prolapse
• Concomitant non-urogynecologic surgery
• Planned further surgery in the next 3 months or anticipated treatment which would result in prolonged inactivity (such as a cancer diagnosis) 3 months postoperatively

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• Brubaker L, Barber MD, Nygaard I, Nager CW, Varner E, Schaffer J, Visco A, Meikle S, Spino C; Pelvic Floor Disorders Network. Quantification of vaginal support: are continuous summary scores better than POPQ stage? Am J Obstet Gynecol. 2010 Nov;203(5):512.e1-6. doi: 10.1016/j.ajog.2010.06.071. Epub 2010 Aug 21.

  PMID: 20728072 BACKGROUND

• Tomioka K, Iwamoto J, Saeki K, Okamoto N. Reliability and validity of the International Physical Activity Questionnaire (IPAQ) in elderly adults: the Fujiwara-kyo Study. J Epidemiol. 2011;21(6):459-65. doi: 10.2188/jea.je20110003. Epub 2011 Sep 24.

  PMID: 21946625 BACKGROUND

• O'Shea M, Siddiqui NY, Truong T, Erkanli A, Barber MD. Standard Restrictions vs Expedited Activity After Pelvic Organ Prolapse Surgery: A Randomized Clinical Trial. JAMA Surg. 2023 Aug 1;158(8):797-805. doi: 10.1001/jamasurg.2023.1649.

  PMID: 37256578 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Barber, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Surgical treatment teams and outcome assessors will be blinded to patient's treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled non-inferiority trial

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: July 1, 2020
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)