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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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).
- Conditions
- Pelvic Organ Prolapse
- 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 group | Role | What they receive |
|---|---|---|
| Expedited postoperative activity instructions | Ad lib postoperative activity and return to work recommendations Receives: Behavioral: Expedited postoperative activity instructions | |
| Standard postoperative activity restrictions | Standard 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.
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)
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
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
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
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
Physical function as measured by a 2-minute walk test (2MWT)
Measured: 2 years +/- 1 month following the initial prolapse surgery
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.
- First posted16 Sep 2022
- Study start30 Sep 2022
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2-Year Follow-Up: Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse (EVeRLAST)
- ClinicalTrials.gov ID
- NCT05542836
- Acronym / sponsor ID
- PRO00104389_1
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expedited postoperative activity instructions | – | Behavioral: Expedited postoperative activity instructionsAd lib postoperative activity and return to work recommendations |
| Standard postoperative activity restrictions | – | Behavioral: Standard postoperative activity restructionsStandard conservative postoperative activity and return to work recommendations |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible subjects include all patients from the prior EVeRLAST study.
Key inclusion criteria (1 listed)
- Patient who were previously enrolled in the initial EVeRLAST study.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expedited postoperative activity instructionsAd lib postoperative activity and return to work recommendations | Behavioural | Expedited postoperative activity instructions |
| Standard postoperative activity restructionsStandard conservative postoperative activity and return to work recommendations | Behavioural | Standard postoperative activity restrictions |
Primary outcome
Prolapse symptoms measured by the Pelvic Organ Prolapse Distress Inventory (POPDI)
Time frame: 2 year +/- 1 month following the initial prolapse surgery
The POPDI results in scores ranging from 0 to 300; higher scores indicate greater symptom distress.
6 secondary outcomes
Functional activity measured by the Activities Assessment Scale (AAS)
Time frame: 2 year +/- 1 month following the initial prolapse surgery
Physical function assessed by the Global Impression of Improvement
Time frame: 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
Time frame: 2 year +/- 1 month following the initial prolapse surgery
Pelvic floor symptom severity measured by the Pelvic Floor Distress Index (PFDI-20)
Time frame: 2 year +/- 1 month following the initial prolapse surgery
Physical function as measured by a 2-minute walk test (2MWT)
Time frame: 2 years +/- 1 month following the initial prolapse surgery
Physical function as measured by a chair stand test.
Time frame: 2 year +/- 1 month following the initial prolapse surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.