Trial Outcomes & Findings for Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence (NCT NCT00064662)

Last Updated: 2013-05-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

655 participants

Primary outcome timeframe

Two years

Results posted on

2013-05-10

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Burch The Burch colposuspension	Sling Pubovaginal sling, using autologous rectus fascia
Overall Study STARTED	329	326
Overall Study COMPLETED	255	265
Overall Study NOT COMPLETED	74	61

Reasons for withdrawal

Reasons for withdrawal
Measure	Burch The Burch colposuspension	Sling Pubovaginal sling, using autologous rectus fascia
Overall Study Death	1	1
Overall Study Lost to Follow-up	57	44
Overall Study Withdrawal by Subject	14	14
Overall Study Administratively withdrawn	2	2

Baseline Characteristics

Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Burch n=329 Participants The Burch colposuspension	Sling n=326 Participants Pubovaginal sling, using autologous rectus fascia	Total n=655 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	289 Participants n=5 Participants	285 Participants n=7 Participants	574 Participants n=5 Participants
Age, Categorical >=65 years	40 Participants n=5 Participants	41 Participants n=7 Participants	81 Participants n=5 Participants
Age Continuous	52.2 years STANDARD_DEVIATION 10.5 • n=5 Participants	51.6 years STANDARD_DEVIATION 10.1 • n=7 Participants	51.9 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	329 Participants n=5 Participants	326 Participants n=7 Participants	655 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	329 participants n=5 Participants	326 participants n=7 Participants	655 participants n=5 Participants

PRIMARY outcome

Timeframe: Two years

Population: All participants randomized were included in time to event analysis.

Outcome measures

Outcome measures
Measure	Burch n=329 Participants The Burch colposuspension	Sling n=326 Participants Pubovaginal sling, using autologous rectus fascia
24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success).	38 % success at 24 months Interval 32.0 to 44.0	47 % success at 24 months Interval 41.0 to 53.0

PRIMARY outcome

Timeframe: Two years

Population: All participants randomized were included in time to event analysis

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.

Outcome measures

Outcome measures
Measure	Burch n=329 Participants The Burch colposuspension	Sling n=326 Participants Pubovaginal sling, using autologous rectus fascia
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 Interval 43.0 to 55.0	66 % stress-specific success at 24 m Interval 60.0 to 71.0

Adverse Events

Burch

Serious events: 32 serious events

Other events: 156 other events

Deaths: 0 deaths

Sling

Serious events: 42 serious events

Other events: 206 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Burch n=329 participants at risk The Burch colposuspension	Sling n=326 participants at risk Pubovaginal sling, using autologous rectus fascia
Renal and urinary disorders Genitourinary	5.5% 18/329 • Number of events 22 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	8.9% 29/326 • Number of events 30 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Injury, poisoning and procedural complications Pelvic pain	0.00% 0/329 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	0.61% 2/326 • Number of events 2 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Injury, poisoning and procedural complications Bleeding	0.91% 3/329 • Number of events 3 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	0.31% 1/326 • Number of events 1 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Injury, poisoning and procedural complications Wound complication requiring surgical intervention	3.6% 12/329 • Number of events 13 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	3.1% 10/326 • Number of events 11 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Gastrointestinal disorders Gastrointestinal	0.30% 1/329 • Number of events 1 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	0.31% 1/326 • Number of events 1 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Respiratory, thoracic and mediastinal disorders Respiratory distress requiring intubation	0.00% 0/329 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	0.31% 1/326 • Number of events 1 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Respiratory, thoracic and mediastinal disorders Laryngospasm requiring reintubation	0.00% 0/329 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	0.31% 1/326 • Number of events 1 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.

Other adverse events

Other adverse events
Measure	Burch n=329 participants at risk The Burch colposuspension	Sling n=326 participants at risk Pubovaginal sling, using autologous rectus fascia
Renal and urinary disorders Genitourinary	31.9% 105/329 • Number of events 203 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	48.2% 157/326 • Number of events 305 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Vascular disorders Vascular/ Hematologic	1.5% 5/329 • Number of events 5 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	2.8% 9/326 • Number of events 9 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Injury, poisoning and procedural complications Wound complication not requiring surgical intervention	18.8% 62/329 • Number of events 69 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	20.2% 66/326 • Number of events 71 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Respiratory, thoracic and mediastinal disorders Pulmonary	3.0% 10/329 • Number of events 10 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	2.8% 9/326 • Number of events 9 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Nervous system disorders Neurologic	1.8% 6/329 • Number of events 6 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	1.5% 5/326 • Number of events 5 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Cardiac disorders Cardiovascular	0.00% 0/329 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	0.61% 2/326 • Number of events 2 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Skin and subcutaneous tissue disorders Allergic (hives, itching)	0.00% 0/329 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	0.61% 2/326 • Number of events 2 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
General disorders Constitutional	0.91% 3/329 • Number of events 3 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	0.00% 0/326 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Skin and subcutaneous tissue disorders Dermatologic (rash, erythema)	0.61% 2/329 • Number of events 2 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	1.2% 4/326 • Number of events 4 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
Gastrointestinal disorders Gastrointestinal	2.1% 7/329 • Number of events 7 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.	2.5% 8/326 • Number of events 8 • 24 months Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.

Additional Information

Anne M. Stoddard, ScD

New England Research Institutes

Phone: 617-972-3331

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place