Urinary Incontinence
Conditions
Keywords
Stress urinary incontinence, Surgery
Brief summary
The primary aim of this clinical trial is to compare the treatment success for two surgical procedures that are frequently used and have similar cure rates, yet have not been compared directly to each other in a large, rigorously conducted randomized trial. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and need for other treatment(s)after surgery. Follow-up will be a minimum of two years and up to four years.
Interventions
PROCEDUREBurch Modified Tanagho
The Burch colposuspension is a well-established procedure for surgically treating women with stress urinary incontinence. The Burch modified colposuspension suspends the anterior vaginal wall (at the level of the bladder neck) with permanent sutures tied to the iliopectineal ligament.
PROCEDUREAutologous Fascia Sling
The fascial sling is also a well-established procedure for surgically treating women with stress urinary incontinence. The autologous sling procedure places a harvested strip of rectus fascia transvaginally at the level of the proximal urethra. The fascial strip is secured superiorly to the rectus fascia with permanent sutures
Sponsors
University of Alabama at Birmingham
University of California, San Diego
University of Maryland
University of Pittsburgh
University of Texas
The University of Texas at San Antonio
University of Utah
Beaumont Hospital
Loyola University
Carelon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Predominant stress urinary incontinence by self-report,examination and test; * Urethral hypermobility; * Eligible for both surgical procedures; * Ambulatory; * Not pregnant; * \>12 months post-partum; * No systemic disease known to affect bladder function; * No current chemotherapy or radiation therapy; * No urethral diverticulum, augmentation cytoplasty, or artificial sphincter; * No recent pelvic surgery; * Available for follow-up and able to complete study assessments; * Signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). | Two years | Success defined as composite measure including: no self-reported incontinence symptoms reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire, \<15g in pad weight during 24 hr pad test, no incontinence episodes on 3-day voiding diary, negative results (no leakage) on provocative stress test at standardized bladder volume, no retreatment for urinary incontinence. Additional treatment for stress urinary incontinence (SUI) includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI. |
| 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) | Two years | Stress-specific success defined by composite measure including: no self-reported symptoms of stress incontinence reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire , negative results (no leakage) on a provocative stress test at standardized bladder volume and no retreatment for stress incontinence Additional treatment for SUI includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI. |
Countries
United States
Participant flow
Recruitment details
Between February 2002 and June 2004 at nine study sites, 2,405 women were screened: 556 were ineligible, 1,193 declined or withdrew consent and one died.
Participants by arm
| Arm | Count |
|---|---|
| Burch The Burch colposuspension | 329 |
| Sling Pubovaginal sling, using autologous rectus fascia | 326 |
| Total | 655 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administratively withdrawn | 2 | 2 |
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 57 | 44 |
| Overall Study | Withdrawal by Subject | 14 | 14 |
Baseline characteristics
| Characteristic | Sling | Burch | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 41 Participants | 40 Participants | 81 Participants |
| Age, Categorical Between 18 and 65 years | 285 Participants | 289 Participants | 574 Participants |
| Age Continuous | 51.6 years STANDARD_DEVIATION 10.1 | 52.2 years STANDARD_DEVIATION 10.5 | 51.9 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 326 participants | 329 participants | 655 participants |
| Sex: Female, Male Female | 326 Participants | 329 Participants | 655 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 | 156 / 329 | 206 / 326 |
| serious Total, serious adverse events | 32 / 329 | 42 / 326 |
Outcome results
Primary
24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success)
Stress-specific success defined by composite measure including: no self-reported symptoms of stress incontinence reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire , negative results (no leakage) on a provocative stress test at standardized bladder volume and no retreatment for stress incontinence Additional treatment for SUI includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.
Time frame: Two years
Population: All participants randomized were included in time to event analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Burch | 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) | 49 % stress-specific success at 24 m |
| Sling | 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) | 66 % stress-specific success at 24 m |
Comparison: Time to event analysis of cumulative success rates in the two groups. Null hypothesis is that the distributions are equal in the two groups.p-value: <0.001Log Rank
Comparison: Kaplan Meier time-to-event analysis of cumulative success rates. Used Wald test of equality of survival distributions.p-value: <0.0001Kalpan Meier (Wald statistic)
Primary
24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success).
Success defined as composite measure including: no self-reported incontinence symptoms reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire, \<15g in pad weight during 24 hr pad test, no incontinence episodes on 3-day voiding diary, negative results (no leakage) on provocative stress test at standardized bladder volume, no retreatment for urinary incontinence. Additional treatment for stress urinary incontinence (SUI) includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.
Time frame: Two years
Population: All participants randomized were included in time to event analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Burch | 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). | 38 % success at 24 months |
| Sling | 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). | 47 % success at 24 months |
Comparison: Time to event analysis of 24 month success rates. Null hypothesis is that the distributions in the two groups are equal.p-value: 0.01Log Rank