Pelvic Organ ProlapseReCOUPNCT02138487
Restricted Convalescence: Outcomes Following Urogynecologic Procedures
A study testing liberal postoperative activity and Restricted postoperative activity in people with Pelvic Organ Prolapse, run by Northwestern University at 3 sites in United States.
Trial summary
The investigators are conducting a study to better understand the relationship between activity restrictions and women's satisfaction following urogynecologic surgery for prolapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- liberal postoperative activity and Restricted postoperative activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2014to Jan 2020
- Phase
- Interventional
- 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
Who may be able to join
- Ambulatory women undergoing surgical management of pelvic organ prolapse
- Prolapse > to Stage II on POP-Q
- Age >18 yrs
- Completed childbearing
- All subjects must have given signed, informed consent prior to registration on study
- All subjects must be able to read and complete study documents
Who cannot join
- Wheelchair-bound women
- Women with neurologic disease (Multiple Sclerosis, Parkinson's Disease)
- Abdominal approach with laparotomy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Virginia Tech Carilion School of Medicine
Roanoke, Virginia, 24016
About this study
The investigators are conducting a study to better understand the relationship between activity restrictions and women's satisfaction following urogynecologic surgery for prolapse. We hypothesize that women with less stringent postoperative restrictions will have higher levels of satisfaction 12 weeks following surgery with no difference in respect to anatomic outcome.
Read the detailed description
Pelvic floor disorders (PFD) dramatically affect millions of women's quality of life (QOL), and 30% of American women will undergo reconstructive surgery for urinary incontinence or pelvic organ prolapse to improve bothersome symptoms and quality of life. Surgical goals of women with PFD is often to resume their normal activities, which they have limited secondary to bothersome symptoms. Yet, traditionally surgeons placed strict postoperative restrictions on patient's activity levels for 3 months; sometimes even recommending life long lifting and activity restrictions. Activity restrictions are imposed on the premise that exercise can "weaken" surgical healing; however, emerging data from other fields suggests that increased activity may actually promote the healing process. We aim to determine whether satisfaction, recovery, and anatomic outcomes after surgery are related to type of postoperative activity recommendations (liberal versus restricted). Women having surgery for PFD will be randomized to receive either liberal or restricted postoperative activity recommendations and satisfaction, symptoms, QOL and anatomic outcomes will be measured after surgery. We hypothesize that women with liberal activity recommendations will recover more quickly and report higher satisfaction and QOL, have fewer symptoms, and have similar anatomic outcomes to women with restricted activity restrictions. These data will change paradigms of women's health and recovery after surgery.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- liberal postoperative activity, Restricted postoperative activity
- Keywords
- pelvic organ prolapse, reconstructive pelvic surgery, postoperative restrictions, patient satisfaction
- Medical subject headings
- Pelvic Organ Prolapse, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liberal postoperative activityOther
Women will be given specific instructions regarding postoperative activities and will not have any limitations regarding activity.
Restricted postoperative activityOther
Women in this group will be given instructions regarding postoperative activity and will need to abstain from heavy lifting, running, aerobics for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Restricted postoperative activity | Active comparator | Women in the "restricted postoperative activity" group must abstain from exercise and heavy lifting for 3 months postoperatively Receives: Other: Restricted postoperative activity |
| Liberal postoperative activity | Experimental | Women in the "liberal postoperative activity" group will be allowed to resume their normal activities without restriction. Receives: Other: liberal postoperative activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction
Satisfaction will be assessed following reconstructive pelvic surgery for prolapse using a question which assesses a patient's global impression. Specifically, patients will be asked the question "how satisfied are you with your prolapse surgery?" at 12 wks to assess overall satisfaction. Possible responses include "completely satisfied," "mostly satisfied," "neutral," "mostly dissatisfied," and "completely dissatisfied."
Measured: 12 weeks following surgery
Secondary outcomes (4)
Anatomic Outcomes
Anatomic outcomes will be assessed on physical examination 12 weeks and 1-year following reconstructive pelvic surgery.
Measured: 12 weeks and 1 year following surgery
Quality of Life
Quality of life will be assessed using several validated questionnaires at 12 weeks and 1 year following reconstructive pelvic surgery for prolapse.
Measured: 12 weeks and 1 year following surgery
Pain
Pain will be assessed using a visual analog scale at 12 weeks and 1 year following reconstructive pelvic surgery.
Measured: 12 weeks and 1 year following surgery
Activity level
Activity level will be assessed using a validated questionnaire at 12 weeks and 1 year following reconstructive pelvic surgery.
Measured: 12 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Northwestern 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Kenton, Northwestern University
- Investigators
- Kimberly Kenton, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138487
- Sponsor's protocol ID
- STU00084995
- Acronym
- ReCOUP
- Status last verified
- Jun 2020
- First submitted
- 8 May 2014
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mueller MG, Collins SA, Lewicky-Gaupp C, Tavathia M, Kenton K. Restricted Convalescence Following Urogynecologic Procedures: 1-Year Outcomes From a Randomized Controlled Study. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e336-e341. doi: 10.1097/SPV.0000000000000922.
PubMed 32947549Bochenska K, Hall E, Griffith JW, Kenton K, Alverdy A, Lewicky-Gaupp C, Mueller M. The Promise of PROMIS in Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2019 Nov-Dec;25(6):426-429. doi: 10.1097/SPV.0000000000000685.
PubMed 30570502Mueller MG, Lewicky-Gaupp C, Collins SA, Abernethy MG, Alverdy A, Kenton K. Activity Restriction Recommendations and Outcomes After Reconstructive Pelvic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Apr;129(4):608-614. doi: 10.1097/AOG.0000000000001924.
PubMed 28277355
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restricted Convalescence: Outcomes Following Urogynecologic Procedures
- ClinicalTrials.gov ID
- NCT02138487
- Acronym / sponsor ID
- ReCOUP / STU00084995
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, reconstructive pelvic surgery, postoperative restrictions, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 14 May 2014 (estimated)
- 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 investigators are conducting a study to better understand the relationship between activity restrictions and women's satisfaction following urogynecologic surgery for prolapse. We hypothesize that women with less stringent postoperative restrictions will have higher levels of satisfaction 12 weeks following surgery with no difference in respect to anatomic outcome.
Detailed description
Pelvic floor disorders (PFD) dramatically affect millions of women's quality of life (QOL), and 30% of American women will undergo reconstructive surgery for urinary incontinence or pelvic organ prolapse to improve bothersome symptoms and quality of life. Surgical goals of women with PFD is often to resume their normal activities, which they have limited secondary to bothersome symptoms. Yet, traditionally surgeons placed strict postoperative restrictions on patient's activity levels for 3 months; sometimes even recommending life long lifting and activity restrictions. Activity restrictions are imposed on the premise that exercise can "weaken" surgical healing; however, emerging data from other fields suggests that increased activity may actually promote the healing process. We aim to determine whether satisfaction, recovery, and anatomic outcomes after surgery are related to type of postoperative activity recommendations (liberal versus restricted). Women having surgery for PFD will be randomized to receive either liberal or restricted postoperative activity recommendations and satisfaction, symptoms, QOL and anatomic outcomes will be measured after surgery. We hypothesize that women with liberal activity recommendations will recover more quickly and report higher satisfaction and QOL, have fewer symptoms, and have similar anatomic outcomes to women with restricted activity restrictions. These data will change paradigms of women's health and recovery after surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restricted postoperative activity | Active comparator | Other: Restricted postoperative activityWomen in the "restricted postoperative activity" group must abstain from exercise and heavy lifting for 3 months postoperatively |
| Liberal postoperative activity | Experimental | Other: liberal postoperative activityWomen in the "liberal postoperative activity" group will be allowed to resume their normal activities without restriction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ambulatory women undergoing surgical management of pelvic organ prolapse
- Prolapse > to Stage II on POP-Q
- Age >18 yrs
- Completed childbearing
- All subjects must have given signed, informed consent prior to registration on study
Key exclusion criteria (3 listed)
- Wheelchair-bound women
- Women with neurologic disease (Multiple Sclerosis, Parkinson's Disease)
- Abdominal approach with laparotomy
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 |
|---|---|---|
| liberal postoperative activityWomen will be given specific instructions regarding postoperative activities and will not have any limitations regarding activity. | Other | Liberal postoperative activity |
| Restricted postoperative activityWomen in this group will be given instructions regarding postoperative activity and will need to abstain from heavy lifting, running, aerobics for 3 months. | Other | Restricted postoperative activity |
Primary outcome
Satisfaction
Time frame: 12 weeks following surgery
Satisfaction will be assessed following reconstructive pelvic surgery for prolapse using a question which assesses a patient's global impression. Specifically, patients will be asked the question "how satisfied are you with your prolapse surgery?" at 12 wks to assess overall satisfaction. Possible responses include "completely satisfied," "mostly satisfied," "neutral," "mostly dissatisfied," and "completely dissatisfied."
4 secondary outcomes
Anatomic Outcomes
Time frame: 12 weeks and 1 year following surgery
Quality of Life
Time frame: 12 weeks and 1 year following surgery
Pain
Time frame: 12 weeks and 1 year following surgery
Activity level
Time frame: 12 weeks and 1 year
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 4 Jun 2020.
- Derived from this study: PubMed 32947549Mueller MG, Collins SA, Lewicky-Gaupp C, Tavathia M, Kenton K. Restricted Convalescence Following Urogynecologic Procedures: 1-Year Outcomes From a Randomized Controlled Study. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e336-e341. doi: 10.1097/SPV.0000000000000922.
- Derived from this study: PubMed 30570502Bochenska K, Hall E, Griffith JW, Kenton K, Alverdy A, Lewicky-Gaupp C, Mueller M. The Promise of PROMIS in Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2019 Nov-Dec;25(6):426-429. doi: 10.1097/SPV.0000000000000685.
- Derived from this study: PubMed 28277355Mueller MG, Lewicky-Gaupp C, Collins SA, Abernethy MG, Alverdy A, Kenton K. Activity Restriction Recommendations and Outcomes After Reconstructive Pelvic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Apr;129(4):608-614. doi: 10.1097/AOG.0000000000001924.
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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.
Kimberly Kenton, MD principal investigator
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liberal postoperative activity and Restricted postoperative activity in people with Pelvic Organ Prolapse, run by Northwestern University at 3 sites 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 3 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Satisfaction (time frame: 12 weeks following surgery). 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 NCT02138487, which also lists 3 linked publications.
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 4 Jun 2020.