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| ID | Type | Description | Link |
|---|---|---|---|
| 2U01HD041249 | U.S. NIH Grant/Contract | View source | |
| 2U10HD041250 | U.S. NIH Grant/Contract | View source | |
| 2U10HD041261 | U.S. NIH Grant/Contract | View source | |
| 2U10HD041267 | U.S. NIH Grant/Contract | View source | |
| 1U10HD054136 | U.S. NIH Grant/Contract | View source | |
| 1U10HD054214 | U.S. NIH Grant/Contract | View source | |
| 1U10HD054215 | U.S. NIH Grant/Contract | View source | |
| 1U10HD054241 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Office of Research on Women's Health (ORWH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Tension-free Vaginal Tape (TVT) surgery |
|
| 2 | Sham Comparator | Sham Tension-free Vaginal Tape (TVT) surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TVT | Device | Prophylactic TVT |
| |
| Sham |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months, and 12 Months post-surgery |
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Inclusion Criteria:
Vaginal bulge symptoms as indicated by an affirmative response to either questions 4 or 5 of the PFDI:
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.
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| John T Wei, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35233-7333 | United States | ||
| USCD Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22716974 | Background | 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. | |
| 41649019 | Derived | Baessler 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. |
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Participants consisted of women who were being considered for an apical and/or anterior vaginal prolapse repair via a vaginal approach without subjective complaints of SUI. They must have had vaginal bulge symptoms (defined as positive responses to the PFDI), and anterior vaginal prolapse with point Aa at -1cm or greater (determined by POP-Q).
All women presenting to the participating PFDN clinical centers with the complaint of prolapse, as defined by the inclusion criteria, will be screened for the subjective complaint of SUI using items on the PFDI. Eligible individuals will be offered RCT participation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Midurethral Sling | Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure. |
| FG001 | Sham Incision | Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Midurethral Sling | Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure. |
| BG001 | Sham Incision | Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 3 months post-surgery |
|
12 months after index surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Midurethral Sling | Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA(V19.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder perforation | Injury, poisoning and procedural complications | MedDRA(V19.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie Gantz | RTI International | 919-597-5110 | mgantz@rti.org |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Other |
Sham TVT |
|
| 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 3 months, and 12 months post-surgery |
| La Jolla |
| California |
| 92037 |
| United States |
| Kaiser Permanente | San Diego | California | 92120 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| UT Southwestern | Dallas | Texas | 35249 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| 32769645 | Derived | Lukacz 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Annual Income <$30,000 | Self-reported question, population is those who provided a response. | Count of Participants | Participants |
|
| Married | Self-reported question, population is those who provided a response. | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | Kg/m^2 |
|
| Pelvic Organ Prolapse Quantification | (1=lowest point of prolapse is >1cm above the hymen; 2=within 1 cm above or below the hymen; 3= >1cm below the hymen but protrudes no more than 2cm less than the total vaginal length; 4=complete vaginal eversion) | Count of Participants | Participants |
|
| 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 300ml. | Count of Participants | Participants |
|
| Anterior Vaginal - Prolapse Repair | Count of Participants | Participants |
|
| Posterior Vaginal - Prolapse Repair | Count of Participants | Participants |
|
| Previous Hysterectomy | Count of Participants | Participants |
|
| Concomitant Hysterectomy | Count of Participants | Participants |
|
|
|
| Primary | Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery | Defined as a positive cough stress test or report of bothersome incontinence symptoms. | Posted | Count of Participants | Participants | 12 months post-surgery |
|
|
|
| Secondary | 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. | Women who completed the Medical Outcomes Study 36-Item Short Form Health Survey at baseline and 3 and 12 months after the index surgery. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months, and 12 Months post-surgery |
|
|
|
| Secondary | 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. | Women who came in for 3 and 12 month post-op office visits and completed a cough stress test. | Posted | Count of Participants | Participants | 3 and 12 Months Post-surgery |
|
|
|
| Secondary | 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). | Women who completed questions in the Pelvic Floor Distress Inventory regarding leakage 3 and 12 months after their index surgery. | Posted | Count of Participants | Participants | 3 and 12 Months Post-surgery |
|
|
|
| Secondary | 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. | Women who reported whether or not they needed treatment for any urinary incontinence. | Posted | Count of Participants | Participants | 3 months post-surgery |
|
|
|
| Secondary | 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. | Women who completed the PFDI UDI survey at baseline and 3 and 12 months after the index surgery. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months, and 12 months post-surgery |
|
|
|
| Secondary | 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. | Women who completed the UDI obstructive symptom subscale survey at baseline and 3 and 12 months after the index surgery. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months, and 12 months post-surgery |
|
|
|
| Secondary | 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. | Women who completed the UDI irritative symptom subscale survey at baseline and 3 months after the index surgery. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months, and 12 months post-surgery |
|
|
|
| Secondary | 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. | Women who completed the UDI stress subscale survey at baseline and 3 and 12 months after the index surgery. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months, and 12 months post-surgery |
|
|
|
| Secondary | 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. | Women who completed the Incontinence Severity Index survey at baseline and 3 and 12 months after the index surgery. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months, and 12 months post-surgery |
|
|
|
| 28 |
| 165 |
| 92 |
| 165 |
| EG001 | Sham Incision | Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group. | 20 | 172 | 63 | 172 |
| Congestive heart failure | Cardiac disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Pulse decreased | Investigations | MedDRA(V19.0) | Non-systematic Assessment |
|
| Abnormal electrocardiogram | Investigations | MedDRA(V19.0) | Non-systematic Assessment |
|
| Hypoxia | Injury, poisoning and procedural complications | MedDRA(V19.0) | Non-systematic Assessment |
|
| Hypotension | Injury, poisoning and procedural complications | MedDRA(V19.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Chest Pain | General disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Fluid Overload | Metabolism and nutrition disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA(V19.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Prolapse repair | Surgical and medical procedures | MedDRA(V19.0) | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA(V19.0) | Non-systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA(V19.0) | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Rectocele repair | Surgical and medical procedures | MedDRA(V19.0) | Non-systematic Assessment |
|
| Haematoma | Injury, poisoning and procedural complications | MedDRA(V19.0) | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA(V19.0) | Non-systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA(V19.0) | Non-systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA(V19.0) | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA(V19.0) | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA(V19.0) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(V19.0) | Non-systematic Assessment |
|
| Mammogram abnormal | Investigations | MedDRA(V19.0) | Non-systematic Assessment |
|
| Pain postoperative | Injury, poisoning and procedural complications | MedDRA(V19.0) | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Pyelonephritis | Renal and urinary disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA(V19.0) | Non-systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Vaginal haemorrhage postoperative | Injury, poisoning and procedural complications | MedDRA(V19.0) | Non-systematic Assessment |
|
| Vaginal abscess | Infections and infestations | MedDRA(V19.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA(V19.0) | Non-systematic Assessment |
|
| Bladder retention at hospital discharge | Renal and urinary disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
| Bladder retention at 2 weeks | Renal and urinary disorders | MedDRA(V19.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| 3 Months - Physical Component |
|
|
| 12 Months - Mental Component |
|
|
| 12 Months - Physical Component |
|
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| 12 Months |
|
|
| 12 Months |
|
|
| 12 Months |
|
|
| 12 Months |
|
|
| 12 Months |
|
|
| 12 Months |
|
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| 12 Months |
|
|