Pelvic Organ Prolapse
Conditions
Keywords
Prolapse, Urinary incontinence, TVT
Brief 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. 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: 1. 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. 2. 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. 3. 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.
Interventions
DEVICETVT
Prophylactic TVT
OTHERSham
Sham TVT
Sponsors
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)
NICHD Pelvic Floor Disorders Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
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: * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence | 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 | 12 months post-surgery | Defined as a positive cough stress test or report of bothersome incontinence symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of Incontinence | 3 and 12 Months Post-surgery | 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). |
| Treatment for Incontinence | 3 months post-surgery | 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. |
| Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) | Baseline, 3 months, and 12 months post-surgery | 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. |
| Medical Outcomes Study 36-Item Short Form Health Survey | Baseline, 3 months, and 12 Months post-surgery | 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. |
| Urinary Distress Inventory (UDI) Irritative Symptom Subscale | Baseline, 3 months, and 12 months post-surgery | 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. |
| Urinary Distress Inventory (UDI) Stress Subscale | Baseline, 3 months, and 12 months post-surgery | 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. |
| Incontinence Severity Index | Baseline, 3 months, and 12 months post-surgery | 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. |
| Urinary Distress Inventory (UDI) Obstructive Symptom Subscale | Baseline, 3 months, and 12 months post-surgery | 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. |
| Positive Cough Stress Test | 3 and 12 Months Post-surgery | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Midurethral Sling Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure. | 165 |
| Sham Incision Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group. | 172 |
| Total | 337 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 7 |
Baseline characteristics
| Characteristic | Midurethral Sling | Sham Incision | Total |
|---|---|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 10.8 | 62.2 years STANDARD_DEVIATION 10.2 | 62.8 years STANDARD_DEVIATION 10.5 |
| Annual Income <$30,000 | 31 Participants | 27 Participants | 58 Participants |
| Anterior Vaginal - Prolapse Repair Anterior Repair Only | 20 Participants | 17 Participants | 37 Participants |
| Anterior Vaginal - Prolapse Repair Apical Suspension Only | 32 Participants | 42 Participants | 74 Participants |
| Anterior Vaginal - Prolapse Repair Both Anterior Repair and Apical Suspension | 101 Participants | 100 Participants | 201 Participants |
| Anterior Vaginal - Prolapse Repair Colpocleisis | 11 Participants | 13 Participants | 24 Participants |
| Body Mass Index | 27.8 Kg/m^2 STANDARD_DEVIATION 4.9 | 28.1 Kg/m^2 STANDARD_DEVIATION 5.5 | 28.0 Kg/m^2 STANDARD_DEVIATION 5.2 |
| Concomitant Hysterectomy | 82 Participants | 83 Participants | 165 Participants |
| Married | 121 Participants | 101 Participants | 222 Participants |
| Pelvic Organ Prolapse Quantification 2 | 45 Participants | 48 Participants | 93 Participants |
| Pelvic Organ Prolapse Quantification 3 | 107 Participants | 106 Participants | 213 Participants |
| Pelvic Organ Prolapse Quantification 4 | 13 Participants | 18 Participants | 31 Participants |
| Positive Cough Stress Test | 54 Participants | 57 Participants | 111 Participants |
| Posterior Vaginal - Prolapse Repair | 74 Participants | 80 Participants | 154 Participants |
| Previous Hysterectomy | 62 Participants | 66 Participants | 128 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Black | 10 Participants | 14 Participants | 24 Participants |
| Race/Ethnicity, Customized Hispanic | 21 Participants | 27 Participants | 48 Participants |
| Race/Ethnicity, Customized Not Hispanic | 144 Participants | 145 Participants | 289 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 13 Participants | 22 Participants |
| Race/Ethnicity, Customized White | 143 Participants | 143 Participants | 286 Participants |
| Sex: Female, Male Female | 165 Participants | 172 Participants | 337 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 92 / 165 | 63 / 172 |
| serious Total, serious adverse events | 28 / 165 | 20 / 172 |
Outcome results
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.
Time frame: 3 months post-surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Midurethral Sling | Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence | 39 Participants |
| Sham Incision | Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence | 85 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.
Time frame: 12 months post-surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Midurethral Sling | Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery | 45 Participants |
| Sham Incision | Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery | 74 Participants |
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.
Time frame: Baseline, 3 months, and 12 months post-surgery
Population: Women who completed the Incontinence Severity Index survey at baseline and 3 and 12 months after the index surgery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Midurethral Sling | Incontinence Severity Index | 3 Months | -0.9 units on a scale | Standard Deviation 3.01 |
| Midurethral Sling | Incontinence Severity Index | 12 Months | -0.9 units on a scale | Standard Deviation 2.7 |
| Sham Incision | Incontinence Severity Index | 3 Months | 0.6 units on a scale | Standard Deviation 3.26 |
| Sham Incision | Incontinence Severity Index | 12 Months | 0.1 units on a scale | Standard Deviation 2.7 |
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.
Time frame: Baseline, 3 months, and 12 Months post-surgery
Population: Women who completed the Medical Outcomes Study 36-Item Short Form Health Survey at baseline and 3 and 12 months after the index surgery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Midurethral Sling | Medical Outcomes Study 36-Item Short Form Health Survey | 3 Months - Mental Component | 1.5 units on a scale | Standard Deviation 9.25 |
| Midurethral Sling | Medical Outcomes Study 36-Item Short Form Health Survey | 3 Months - Physical Component | 2.1 units on a scale | Standard Deviation 8.21 |
| Midurethral Sling | Medical Outcomes Study 36-Item Short Form Health Survey | 12 Months - Mental Component | 1.9 units on a scale | Standard Deviation 8.4 |
| Midurethral Sling | Medical Outcomes Study 36-Item Short Form Health Survey | 12 Months - Physical Component | 3.1 units on a scale | Standard Deviation 9.23 |
| Sham Incision | Medical Outcomes Study 36-Item Short Form Health Survey | 12 Months - Physical Component | 2.3 units on a scale | Standard Deviation 7.51 |
| Sham Incision | Medical Outcomes Study 36-Item Short Form Health Survey | 3 Months - Mental Component | 0.6 units on a scale | Standard Deviation 8.44 |
| Sham Incision | Medical Outcomes Study 36-Item Short Form Health Survey | 12 Months - Mental Component | 2.0 units on a scale | Standard Deviation 8.94 |
| Sham Incision | Medical Outcomes Study 36-Item Short Form Health Survey | 3 Months - Physical Component | 1.5 units on a scale | Standard Deviation 7.52 |
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.
Time frame: Baseline, 3 months, and 12 months post-surgery
Population: Women who completed the PFDI UDI survey at baseline and 3 and 12 months after the index surgery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Midurethral Sling | Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) | 3 Months | -44.9 units on a scale | Standard Deviation 48.24 |
| Midurethral Sling | Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) | 12 Months | -43.1 units on a scale | Standard Deviation 44.25 |
| Sham Incision | Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) | 12 Months | -39.3 units on a scale | Standard Deviation 40.93 |
| Sham Incision | Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) | 3 Months | -34.4 units on a scale | Standard Deviation 44.92 |
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.
Time frame: 3 and 12 Months Post-surgery
Population: Women who came in for 3 and 12 month post-op office visits and completed a cough stress test.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Midurethral Sling | Positive Cough Stress Test | 3 Months | 10 Participants |
| Midurethral Sling | Positive Cough Stress Test | 12 Months | 5 Participants |
| Sham Incision | Positive Cough Stress Test | 12 Months | 31 Participants |
| Sham Incision | Positive Cough Stress Test | 3 Months | 54 Participants |
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).
Time frame: 3 and 12 Months Post-surgery
Population: Women who completed questions in the Pelvic Floor Distress Inventory regarding leakage 3 and 12 months after their index surgery.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Midurethral Sling | Symptoms of Incontinence | 3 Months | 15 Participants |
| Midurethral Sling | Symptoms of Incontinence | 12 Months | 18 Participants |
| Sham Incision | Symptoms of Incontinence | 12 Months | 30 Participants |
| Sham Incision | Symptoms of Incontinence | 3 Months | 41 Participants |
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.
Time frame: 3 months post-surgery
Population: Women who reported whether or not they needed treatment for any urinary incontinence.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Midurethral Sling | Treatment for Incontinence | 11 Participants |
| Sham Incision | Treatment for Incontinence | 13 Participants |
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.
Time frame: Baseline, 3 months, and 12 months post-surgery
Population: Women who completed the UDI irritative symptom subscale survey at baseline and 3 months after the index surgery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Midurethral Sling | Urinary Distress Inventory (UDI) Irritative Symptom Subscale | 3 Months | -12.5 units on a scale | Standard Deviation 18.83 |
| Midurethral Sling | Urinary Distress Inventory (UDI) Irritative Symptom Subscale | 12 Months | -10.9 units on a scale | Standard Deviation 17.15 |
| Sham Incision | Urinary Distress Inventory (UDI) Irritative Symptom Subscale | 3 Months | -10.5 units on a scale | Standard Deviation 17.06 |
| Sham Incision | Urinary Distress Inventory (UDI) Irritative Symptom Subscale | 12 Months | -11.6 units on a scale | Standard Deviation 15.87 |
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.
Time frame: Baseline, 3 months, and 12 months post-surgery
Population: Women who completed the UDI obstructive symptom subscale survey at baseline and 3 and 12 months after the index surgery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Midurethral Sling | Urinary Distress Inventory (UDI) Obstructive Symptom Subscale | 3 Months | -27.3 units on a scale | Standard Deviation 22.69 |
| Midurethral Sling | Urinary Distress Inventory (UDI) Obstructive Symptom Subscale | 12 Months | -26.4 units on a scale | Standard Deviation 22.69 |
| Sham Incision | Urinary Distress Inventory (UDI) Obstructive Symptom Subscale | 3 Months | -28.0 units on a scale | Standard Deviation 20.81 |
| Sham Incision | Urinary Distress Inventory (UDI) Obstructive Symptom Subscale | 12 Months | -27.1 units on a scale | Standard Deviation 21.39 |
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.
Time frame: Baseline, 3 months, and 12 months post-surgery
Population: Women who completed the UDI stress subscale survey at baseline and 3 and 12 months after the index surgery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Midurethral Sling | Urinary Distress Inventory (UDI) Stress Subscale | 3 Months | -5.1 units on a scale | Standard Deviation 16.29 |
| Midurethral Sling | Urinary Distress Inventory (UDI) Stress Subscale | 12 Months | -5.7 units on a scale | Standard Deviation 14.62 |
| Sham Incision | Urinary Distress Inventory (UDI) Stress Subscale | 3 Months | 4.2 units on a scale | Standard Deviation 20.42 |
| Sham Incision | Urinary Distress Inventory (UDI) Stress Subscale | 12 Months | -0.5 units on a scale | Standard Deviation 16.89 |