Pelvic Organ ProlapsePhase 2OPUSNCT00460434
Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial
A Phase 2 study testing TVT in people with Pelvic Organ Prolapse, run by NICHD Pelvic Floor Disorders Network at 8 sites in United States.
Trial summary
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision. Some women develop stress urinary incontinence (SUI) after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- TVT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 337 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2007to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Vaginal bulge symptoms as indicated by an affirmative response to either questions 4 or 5 of the PFDI:
- Do you usually have a sensation of bulging or protrusion from the vaginal area?
- Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? Anterior vaginal prolapse defined by pelvic organ prolapse quantification (POP-Q) Point Aa ≥ -1 cm (i.e., -1,0,1,2, or 3 cm).
- Surgical plan that includes a vaginal approach for apical or anterior prolapse repair.
- Able and willing to complete data collection per protocol, including written informed consent.
Who cannot join
- Pregnancy or planning pregnancy in the first postoperative year. Any prior mid urethral sling. Currently participating in another interventional study for urinary incontinence.
- Untreated urinary tract infection (may be included after resolution).
- Overt symptoms of stress urinary incontinence as defined by a positive response to any of the following 3 PFDI items:
- Do you usually experience urine leakage related to coughing, sneezing, or laughing?
- Do you usually experience urine leakage related to physical exercise such as walking, running, aerobics, or tennis?
- Do you usually experience urine leakage related to lifting or bending over? Currently being treated for stress urinary incontinence with pessary/incontinence ring, pelvic floor muscle exercise or medication (duloxetine and imipramine, and alpha agonists).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35233-7333
Cleveland Clinic
Cleveland, Ohio, 44195
UT Southwestern
Dallas, Texas, 35249
Duke University
Durham, North Carolina, 27710
USCD Medical Center
La Jolla, California, 92037
Loyola University Medical Center
Maywood, Illinois, 60153
University of Utah
Salt Lake City, Utah, 84132
Kaiser Permanente
San Diego, California, 92120
About this study
Official title: Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision. Some women develop stress urinary incontinence (SUI) after surgery. A prior randomized trial has shown that use of a Burch sling at the time of an abdominal sacrocolpopexy decreases the risk of urinary incontinence; however, the benefit of adding an anti incontinence procedure to prevent SUI at the time of prolapse surgery performed via a vaginal approach is unclear. Thus, the objective of the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial is to determine whether prophylactic treatment with Tension-free Vaginal Tape (TVT)® at the time of prolapse surgery done via a vaginal approach is effective in preventing urinary incontinence.
Read the detailed description
The overall objective of this randomized clinical trial is to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding TVT® at the time of the prolapse surgery among women with anterior vaginal prolapse but without pre-operative symptoms of stress urinary incontinence.
The primary aims are:
In stress continent women planning vaginal surgery for pelvic organ prolapse:
- To determine if the failure rate defined by subsequent treatment for urinary incontinence, signs or symptoms of bothersome urinary incontinence [defined as having at least moderate bother for any of 4 Pelvic Floor Distress Inventory (PFDI) incontinence items] differs between vaginal prolapse repair and vaginal prolapse repair plus TVT® during the first 3 months after the index surgery.
- To determine if the prevalence of bothersome urinary incontinence at 12 months after the index surgery differs between vaginal prolapse repair and vaginal prolapse repair plus TVT®, whether or not there was subsequent treatment for symptoms of urinary incontinence; i.e., to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding a TVT® at the time of the prolapse surgery.
- To measure the total cost of care and relate the difference in cost of care between the two groups to differences in health utilities and health-related quality of life, which will allow us to examine the cost-effectiveness of prophylactic use of a TVT® at the time of prolapse surgery versus symptom-specific treatment of stress incontinence after prolapse surgery.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- TVT, Sham
- Keywords
- Prolapse, Urinary incontinence, TVT
- Medical subject headings
- Pelvic Organ Prolapse, Prolapse, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVTDevice
Prophylactic TVT
ShamOther
Sham TVT
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tension-free Vaginal Tape (TVT) surgery Receives: Device: TVT |
| 2 | Sham comparator | Sham Tension-free Vaginal Tape (TVT) surgery Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence
Defined as a positive cough stress test, bothersome incontinence symptoms, or treatment for urinary incontinence, and urinary incontinence (stress, urge, or mixed), regardless of whether interim treatment for incontinence had been provided.
Measured: 3 months post-surgery
Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery
Defined as a positive cough stress test or report of bothersome incontinence symptoms.
Measured: 12 months post-surgery
Secondary outcomes (9)
Medical Outcomes Study 36-Item Short Form Health Survey
This survey is a generic health-related quality of life measure. Scores have normalized values with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status. Results measure the average change in scores from baseline to follow-up.
Measured: Baseline, 3 months, and 12 Months post-surgery
Positive Cough Stress Test
A leakage of urine with coughing or straining in either the supine or standing position with the bladder filled through a urethral catheter to 300 ml.
Measured: 3 and 12 Months Post-surgery
Symptoms of Incontinence
Symptoms that were at least moderately bothersome to the participant (as measured by a response of "moderately" or "quite a bit" to any of the four items on the Pelvic Floor Distress Inventory regarding leakage).
Measured: 3 and 12 Months Post-surgery
Treatment for Incontinence
The need for treatment for any urinary incontinence, including surgery, medication, pessary for incontinence, supervised pelvic-muscle exercises, timed voiding and fluid management, periurethral injection, botulinum toxin injection, neuromodulation, or other treatment for incontinence.
Measured: 3 months post-surgery
Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI)
PFDI is a symptom inventory for pelvic floor disorders. Scores ranges from 0 to 300, with higher scores indicating more symptoms. Results measure the average change in scores from baseline to follow-up.
Measured: Baseline, 3 months, and 12 months post-surgery
Urinary Distress Inventory (UDI) Obstructive Symptom Subscale
Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.
Measured: Baseline, 3 months, and 12 months post-surgery
Urinary Distress Inventory (UDI) Irritative Symptom Subscale
Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.
Measured: Baseline, 3 months, and 12 months post-surgery
Urinary Distress Inventory (UDI) Stress Subscale
Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.
Measured: Baseline, 3 months, and 12 months post-surgery
Incontinence Severity Index
Scores on the Incontinence Severity Index range from 1 to 12, with higher scores indicating greater severity. Results measure average change in scores from baseline.
Measured: Baseline, 3 months, and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Pelvic Floor Disorders Network
- Sponsor type
- Research network
- Collaborators
- Office of Research on Women's Health (ORWH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- John T Wei, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460434
- Sponsor's protocol ID
- 15P01
- Other IDs
- 2U01HD041249, 2U10HD041250, 2U10HD041261, 2U10HD041267, 1U10HD054136, 1U10HD054214, 1U10HD054215, 1U10HD054241
- Acronym
- OPUS
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2007
- Last updated
- 30 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.
PubMed 22716974Baessler K, Christmann-Schmid C, Haya N, Mowat A, Chen Z, Wallace SA, Yeung E, Maher C. Surgery for women with pelvic organ prolapse with or without stress urinary incontinence. Cochrane Database Syst Rev. 2026 Feb 6;2(2):CD013108. doi: 10.1002/14651858.CD013108.pub2.
PubMed 41649019Lukacz ES, Sridhar A, Chermansky CJ, Rahn DD, Harvie HS, Gantz MG, Varner RE, Korbly NB, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN). Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse. Obstet Gynecol. 2020 Sep;136(3):492-500. doi: 10.1097/AOG.0000000000003992.
PubMed 32769645
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial
- ClinicalTrials.gov ID
- NCT00460434
- Acronym / sponsor ID
- OPUS / 15P01
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Prolapse, Urinary incontinence, TVT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- NICHD Pelvic Floor Disorders NetworkResearch network
- Collaborators
- Office of Research on Women's Health (ORWH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Apr 2007 (estimated)
- Results
- Posted 11 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision. Some women develop stress urinary incontinence (SUI) after surgery. A prior randomized trial has shown that use of a Burch sling at the time of an abdominal sacrocolpopexy decreases the risk of urinary incontinence; however, the benefit of adding an anti incontinence procedure to prevent SUI at the time of prolapse surgery performed via a vaginal approach is unclear. Thus, the objective of the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial is to determine whether prophylactic treatment with Tension-free Vaginal Tape (TVT)® at the time of prolapse surgery done via a vaginal approach is effective in preventing urinary incontinence.
Detailed description
The overall objective of this randomized clinical trial is to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding TVT® at the time of the prolapse surgery among women with anterior vaginal prolapse but without pre-operative symptoms of stress urinary incontinence.
The primary aims are:
In stress continent women planning vaginal surgery for pelvic organ prolapse:
- To determine if the failure rate defined by subsequent treatment for urinary incontinence, signs or symptoms of bothersome urinary incontinence [defined as having at least moderate bother for any of 4 Pelvic Floor Distress Inventory (PFDI) incontinence items] differs between vaginal prolapse repair and vaginal prolapse repair plus TVT® during the first 3 months after the index surgery.
- To determine if the prevalence of bothersome urinary incontinence at 12 months after the index surgery differs between vaginal prolapse repair and vaginal prolapse repair plus TVT®, whether or not there was subsequent treatment for symptoms of urinary incontinence; i.e., to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding a TVT® at the time of the prolapse surgery.
- To measure the total cost of care and relate the difference in cost of care between the two groups to differences in health utilities and health-related quality of life, which will allow us to examine the cost-effectiveness of prophylactic use of a TVT® at the time of prolapse surgery versus symptom-specific treatment of stress incontinence after prolapse surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: TVTTension-free Vaginal Tape (TVT) surgery |
| 2 | Sham comparator | Other: ShamSham Tension-free Vaginal Tape (TVT) surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Vaginal bulge symptoms as indicated by an affirmative response to either questions 4 or 5 of the PFDI:
- Do you usually have a sensation of bulging or protrusion from the vaginal area?
- Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? Anterior vaginal prolapse defined by pelvic organ prolapse quantification (POP-Q) Point Aa ≥ -1 cm (i.e., -1,0,1,2, or 3 cm).
- Surgical plan that includes a vaginal approach for apical or anterior prolapse repair.
- Able and willing to complete data collection per protocol, including written informed consent.
Key exclusion criteria (6 listed)
- Pregnancy or planning pregnancy in the first postoperative year. Any prior mid urethral sling. Currently participating in another interventional study for urinary incontinence.
- Untreated urinary tract infection (may be included after resolution).
- Overt symptoms of stress urinary incontinence as defined by a positive response to any of the following 3 PFDI items:
- Do you usually experience urine leakage related to coughing, sneezing, or laughing?
- Do you usually experience urine leakage related to physical exercise such as walking, running, aerobics, or tennis?
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 |
|---|---|---|
| TVTProphylactic TVT | Device | 1 |
| ShamSham TVT | Other | 2 |
Primary outcome
Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence
Time frame: 3 months post-surgery
Defined as a positive cough stress test, bothersome incontinence symptoms, or treatment for urinary incontinence, and urinary incontinence (stress, urge, or mixed), regardless of whether interim treatment for incontinence had been provided.
Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery
Time frame: 12 months post-surgery
Defined as a positive cough stress test or report of bothersome incontinence symptoms.
9 secondary outcomes
Medical Outcomes Study 36-Item Short Form Health Survey
Time frame: Baseline, 3 months, and 12 Months post-surgery
Positive Cough Stress Test
Time frame: 3 and 12 Months Post-surgery
Symptoms of Incontinence
Time frame: 3 and 12 Months Post-surgery
Treatment for Incontinence
Time frame: 3 months post-surgery
Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI)
Time frame: Baseline, 3 months, and 12 months post-surgery
Urinary Distress Inventory (UDI) Obstructive Symptom Subscale
Time frame: Baseline, 3 months, and 12 months post-surgery
Urinary Distress Inventory (UDI) Irritative Symptom Subscale
Time frame: Baseline, 3 months, and 12 months post-surgery
Urinary Distress Inventory (UDI) Stress Subscale
Time frame: Baseline, 3 months, and 12 months post-surgery
Incontinence Severity Index
Time frame: Baseline, 3 months, and 12 months post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22716974Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.
- Derived from this study: PubMed 41649019Baessler K, Christmann-Schmid C, Haya N, Mowat A, Chen Z, Wallace SA, Yeung E, Maher C. Surgery for women with pelvic organ prolapse with or without stress urinary incontinence. Cochrane Database Syst Rev. 2026 Feb 6;2(2):CD013108. doi: 10.1002/14651858.CD013108.pub2.
- Derived from this study: PubMed 32769645Lukacz ES, Sridhar A, Chermansky CJ, Rahn DD, Harvie HS, Gantz MG, Varner RE, Korbly NB, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN). Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse. Obstet Gynecol. 2020 Sep;136(3):492-500. doi: 10.1097/AOG.0000000000003992.
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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.
John T Wei, MD principal investigator
University of Michigan
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TVT in people with Pelvic Organ Prolapse, run by NICHD Pelvic Floor Disorders Network at 8 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 5 inclusion and 6 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence (time frame: 3 months post-surgery). The study lists 2 primary outcomes in all. 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 NCT00460434, 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 30 May 2018.