EVeRLAST 2-Year Follow-Up

NCT05542836 | Completed

• 1 other identifier: PRO00104389_1
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 2-year follow-up study from EVeRLAST which objective was to determine whether expedited resumption of postoperative activity levels is non-inferior to standard activity restrictions with respect to short-term anatomic prolapse outcomes. The preliminary data from the original study suggest expedited instructions are non-inferior. We hypothesize this effect continues at the 2-year postoperative mark and patients continue to have non-inferior outcomes after prolapse surgery when compared to standard postoperative activity restrictions. Participants from the original EVeRLAST will be approached to assess their interest in participating in the 2-year follow up study. We will be collecting objective and subjective data.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Prolapse symptoms measured by the Pelvic Organ Prolapse Distress Inventory (POPDI)

  The POPDI results in scores ranging from 0 to 300; higher scores indicate greater symptom distress.

  2 year +/- 1 month following the initial prolapse surgery

Secondary Outcomes (6)

• Functional activity measured by the Activities Assessment Scale (AAS)

  2 year +/- 1 month following the initial prolapse surgery

• Physical function assessed by the Global Impression of Improvement

  2 year +/- 1 month following the initial prolapse surgery

• Physical function assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form

  2 year +/- 1 month following the initial prolapse surgery

• Pelvic floor symptom severity measured by the Pelvic Floor Distress Index (PFDI-20)

  2 year +/- 1 month following the initial prolapse surgery

• Physical function as measured by a 2-minute walk test (2MWT)

  2 years +/- 1 month following the initial prolapse surgery

Study Arms (2)

Expedited postoperative activity instructions

Ad lib postoperative activity and return to work recommendations

Behavioral: Expedited postoperative activity instructions

Standard postoperative activity restrictions

Standard conservative postoperative activity and return to work recommendations

Behavioral: Standard postoperative activity restructions

Interventions

Expedited postoperative activity instructions BEHAVIORAL

Ad lib postoperative activity and return to work recommendations

Expedited postoperative activity instructions

Standard postoperative activity restructions BEHAVIORAL

Standard conservative postoperative activity and return to work recommendations

Standard postoperative activity restrictions

Eligibility Criteria

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

Study Population

Eligible subjects include all patients from the prior EVeRLAST study.

You may qualify if:

• Patient who were previously enrolled in the initial EVeRLAST study.

You may not qualify if:

• Enrollment in another research study of pelvic organ prolapse.
• Any patients who underwent further surgery in the 3 months following their prolapse surgery or patients who underwent unanticipated treatment which would result in prolonged inactivity (such as a cancer diagnosis) 3 months following their prolapse surgery.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27707, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: September 30, 2022
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: December 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)