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Pelvic Organ ProlapseNCT05542836

EVeRLAST 2-Year Follow-Up

An observational study of Pelvic Organ Prolapse, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Pelvic Organ Prolapse
What is being tested?
Expedited postoperative activity instructions and Standard postoperative activity restructions
How many people
63 participants
Where
1 siteUnited States
Study dates
30 Sep 2022to 27 Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Eligible subjects include all patients from the prior EVeRLAST study.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke University Medical Center

    Durham, North Carolina, 27707

Other trials in United States

About this study

Official title: 2-Year Follow-Up: Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse (EVeRLAST)

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.

Read the detailed description

Activity recommendations and lifting restrictions after gynecologic surgery are based on tradition and anecdote. Despite the paucity of evidence to support such recommendations, in a recent survey, 82-86% of minimally invasive gynecologic surgeons recommended postoperative lifting restrictions. Meanwhile, other surgical specialties have begun to depart from these traditional restrictions, recognizing not only the unclear health benefits of a prolonged convalescence, but the economic implications of arbitrarily restricting postoperative labor force participation. For example, following inguinal hernia repair, patients who were able to decide when to return to work took a significantly shorter period of sick leave and hernia recurrence was not found to be higher in those resuming activities the day after surgery.

With respect to prolapse surgery, recommendations related to weight restrictions are primarily based upon theoretical avoidance of intra-abdominal pressure which could compromise the success of a recent reconstructive pelvic floor surgery. However, in a research study of healthy volunteers, daily physiologic events such as Valsalva, coughing, and rising from supine to upright positions generated considerably more intra-abdominal pressure than lifting. In animal studies, mechanical stimulation improves skeletal muscle healing by promoting remodeling, myoblast chemotaxis, and differentiation.6 Thus studies have challenged the notion that avoidance of weight-bearing activities is protective to the reconstructed pelvic floor.

In a recent randomized controlled trial of restrictive versus liberal activity recommendations following prolapse surgery, liberal activity recommendations were associated with similar patient satisfaction yet no differences in short-term anatomic outcomes. While this study added important evidence, it was not powered to detect differences in early anatomic prolapse recurrence, and the literature remains inconclusive regarding the risks (or absence thereof) of recommending liberal resumption of activities following prolapse surgery.

Therefore, the objective of the EVeRLAST study is to conclusively determine whether expedited resumption of postoperative activity levels is non-inferior to standard activity restrictions with respect to anatomic and functional outcomes. We recently presented short-term outcome data, collected three months after surgery, which confirmed that expedited activity is non-inferior to standard activity limitations. We now propose to further follow this study population, with repeat assessments two years after surgery. We hypothesize that those who received expedited postoperative activity instructions will continue to demonstrate non-inferior anatomic and symptomatic outcomes two years after prolapse surgery. We will test this hypothesis by completing the following specific aims.

The follow-up will be conducted remotely via Zoom interviews.

Specific Aim 1: Determine if expedited resumption of postoperative activity levels results in non-inferior symptomatic outcomes when compared to standard activity restrictions at two years after the original surgery.

Specific Aim 2: Compare objective and subjective measures of physical function two years after surgery between those receiving expedited versus standard activity restrictions. Measures include a 2-minute walk test (2MWT), chair stand test, and the Activities Assessment Scale (AAS).

Specific Aim 3: Compare objective and subjective measures of and pelvic floor function two years after surgery in those receiving expedited versus standard activity restrictions. Main outcomes include retreatment (e.g., pessary, surgery), objective anatomic POPQ data, where available, the Pelvic Floor Distress Inventory (PFDI) and impression of improvement using the Patient Global Impression of Improvement scale (PGI-I).

Being tested
Expedited postoperative activity instructions, Standard postoperative activity restructions
Medical subject headings
Pelvic Organ Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expedited postoperative activity instructionsBehavioural

    Ad lib postoperative activity and return to work recommendations

  • Standard postoperative activity restructionsBehavioural

    Standard conservative postoperative activity and return to work recommendations

Study groups in NCT05542836
Study groupRoleWhat they receive
Expedited postoperative activity instructionsAd lib postoperative activity and return to work recommendations
Receives: Behavioral: Expedited postoperative activity instructions
Standard postoperative activity restrictionsStandard conservative postoperative activity and return to work recommendations
Receives: Behavioral: Standard postoperative activity restructions

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)
  1. Functional activity measured by the Activities Assessment Scale (AAS)

    The AAS results in scores that range from 0 to 100; higher scores indicate better physical function/

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

  2. Physical function assessed by the Global Impression of Improvement

    The Global Impression of Improvement results in scores ranging from 1 to 7; higher scores indicate a worse perception of improvement.

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

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

    T-scores will be presented with higher scores represent more of the concept being measured

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

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

    The PFDI-20 results in scores from 0 to 30; higher scores indicate greater symptom distress

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

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

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

  6. Physical function as measured by a chair stand test.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start30 Sep 2022
  3. Primary completion27 Sep 2023
  4. Study completion27 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05542836
Sponsor's protocol ID
PRO00104389_1
Status last verified
Feb 2024
First submitted
13 Sep 2022
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pelvic Organ Prolapse, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prolapse symptoms measured by the Pelvic Organ Prolapse Distress Inventory (POPDI) (time frame: 2 year +/- 1 month following the initial prolapse surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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