Pelvic Organ ProlapseNCT04274491
Predictors of Recovery Expectancy
An observational study of Pelvic Organ Prolapse and Surgery, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to identify factors that influence a person's expectations regarding recovery from pelvic organ prolapse surgery. This is important because a person's expectations regarding recovery from surgery help to predict how a person will actually recover. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Surgery
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 1 Feb 2022
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with greater than or equal to stage II pelvic organ prolapse who are scheduled for reconstructive surgery.
Who may be able to join
- Patients with greater than or equal to stage II pelvic organ prolapse who are scheduled for reconstructive surgery.
- English speaking.
- Over the age of 18.
- Use email as a form of communication.
- Have a reliable internet connection at home.
- Have a computer/smartphone/tablet at home.
Who cannot join
- Non English speaking patients
- Patients without active email.
- Patients without access to reliable internet connection.
- Patients without access to computer/smartphone/tablet.
- Patients with less than stage II prolapse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Urogynecology
Indianapolis, Indiana, 46032
About this study
Official title: Predictors of Recovery Expectancy After Surgery for Pelvic Organ Prolapse
The purpose of this study is to identify factors that influence a person's expectations regarding recovery from pelvic organ prolapse surgery. This is important because a person's expectations regarding recovery from surgery help to predict how a person will actually recover. Our hypothesis is that women with multiple roles will have expectations of a longer surgical recovery time after surgery for pelvic organ prolapse after controlling for known predictors of recovery expectancies. Participants will complete a preoperative online survey. Additional online surveys will be send on postoperative days 14 and 42 to measure postdischarge surgical recovery.
- Conditions
- Pelvic Organ Prolapse, Surgery
- Keywords
- Recovery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Organ Prolapse Surgery Patients | Participants with greater than or equal to stage II pelvic organ prolapse who are scheduled for reconstructive surgery will be recruited. Participants will be asked to complete a preoperative online survey regarding their health, recovery expectancy, and different roles. Additional online surveys will be send on postoperative days 14 and 42 to measure postdischarge surgical recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery Expectancy
Expectation that recovery from surgery will be greater than 6 weeks from 0 to 100 percent where 100% indicates complete recovery within 6 weeks
Measured: Participant will complete preoperative survey at 1 day (once surgery is scheduled).
Secondary outcomes (2)
Post Discharge Recovery
Postdischarge Surgical Recovery Scale 13 which is validated tool for measuring postoperative recovery
Measured: Questionnaire will be completed on post op day #14
Post Discharge Recovery
Postdischarge Surgical Recovery Scale 13 which is validated tool for measuring postoperative recovery
Measured: Questionnaire will be completed on post op day #42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Mar 2020
- Primary completion1 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Indiana 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Doering, Indiana University
- Investigators
- Michael Heit, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274491
- Sponsor's protocol ID
- 2001849013
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doering A, Hale D, Hamner J, Heit M. Predictors of Recovery Expectancy in Preparation for Pelvic Reconstructive Surgery in Women With Pelvic Organ Prolapse: A Prospective Cohort Study. Urogynecology (Phila). 2023 Jul 1;29(7):607-616. doi: 10.1097/SPV.0000000000001327. Epub 2023 Jan 12.
PubMed 36701635
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Recovery Expectancy After Surgery for Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT04274491
- Acronym / sponsor ID
- 2001849013
- Conditions
- Pelvic Organ Prolapse, Surgery
- Keywords
- Recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 18 Feb 2020 (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.
The purpose of this study is to identify factors that influence a person's expectations regarding recovery from pelvic organ prolapse surgery. This is important because a person's expectations regarding recovery from surgery help to predict how a person will actually recover. Our hypothesis is that women with multiple roles will have expectations of a longer surgical recovery time after surgery for pelvic organ prolapse after controlling for known predictors of recovery expectancies. Participants will complete a preoperative online survey. Additional online surveys will be send on postoperative days 14 and 42 to measure postdischarge surgical recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic Organ Prolapse Surgery Patients | – | –Participants with greater than or equal to stage II pelvic organ prolapse who are scheduled for reconstructive surgery will be recruited. Participants will be asked to complete a preoperative online survey regarding their health, recovery expectancy, and different roles. Additional online surveys will be send on postoperative days 14 and 42 to measure postdischarge surgical recovery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with greater than or equal to stage II pelvic organ prolapse who are scheduled for reconstructive surgery.
Key inclusion criteria (6 listed)
- Patients with greater than or equal to stage II pelvic organ prolapse who are scheduled for reconstructive surgery.
- English speaking.
- Over the age of 18.
- Use email as a form of communication.
- Have a reliable internet connection at home.
Key exclusion criteria (5 listed)
- Non English speaking patients
- Patients without active email.
- Patients without access to reliable internet connection.
- Patients without access to computer/smartphone/tablet.
- Patients with less than stage II prolapse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recovery Expectancy
Time frame: Participant will complete preoperative survey at 1 day (once surgery is scheduled).
Expectation that recovery from surgery will be greater than 6 weeks from 0 to 100 percent where 100% indicates complete recovery within 6 weeks
2 secondary outcomes
Post Discharge Recovery
Time frame: Questionnaire will be completed on post op day #14
Post Discharge Recovery
Time frame: Questionnaire will be completed on post op day #42
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 31 Mar 2022.
- Derived from this study: PubMed 36701635Doering A, Hale D, Hamner J, Heit M. Predictors of Recovery Expectancy in Preparation for Pelvic Reconstructive Surgery in Women With Pelvic Organ Prolapse: A Prospective Cohort Study. Urogynecology (Phila). 2023 Jul 1;29(7):607-616. doi: 10.1097/SPV.0000000000001327. Epub 2023 Jan 12.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Michael Heit, MD principal investigator
Indiana University
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 and Surgery, run by Indiana 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 6 inclusion and 5 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 31 Mar 2022. 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?
Recovery Expectancy (time frame: Participant will complete preoperative survey at 1 day (once surgery is scheduled).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04274491, which also lists 1 linked publication.
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 31 Mar 2022.