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Study Title and Description

Laparoscopic Burch colposuspension versus tension-free vaginal tape: a randomized trial.



Key Questions Addressed
1 Sling vs Comparator RCT outcomes (excluding AEs)
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2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Laparoscopic Burch colposuspension versus tension-free vaginal tape: a randomized trial.
Author Paraiso MF., Walters MD., Karram MM., Barber MD.
Country Department of Obstetrics and Gynecology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA. paraism@ccf.org
Year 2004
Numbers Pubmed ID: 15572485
8855 (internal)

Secondary Publication Information
UI Title Author Country Year
2. Randomised trial of laparoscopic Burch colposuspension versus tension-free vaginal tape: long-term followup Jelovsek JE, Barber MD, Karram MM, Walters MD, Paraiso MF 2008
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Extraction Form: Sling vs Comparator RCT outcomes (excluding AEs)
Arms
Number Title Description Comments
1 TVT TVT (Gynecare): either local with IV sedation, or regional or general anesthesia. Upward-pass technique used. All received prophylactic antibiotics. High or low dorsolithotomy position. Antiembolic compression stockings. 18Fr catheter used during cse. 5mm suprapubic incisions made, approx 3cm lateral of midline just above the pubic bone. Retropubic injection of 10cc of 0.25% bupivacaine on each side. 1,5-2cm vertical incision at midurethra, 1 cm from the meatus. Catheter guide was used. Cysto performed after each pass. Cough stress test (local or regional anesthesia) or Crede maneuver (General anesthesia) was performed with 300cc in the bladder. Tape adjusted such that there was minimal leakage during this maneuver. Suprapubic tube was placed.
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2 Burch, laparoscopic Laparoscopic Burch: general anesthesia, prophylactic antibiotics given within 1 hr of surgery, low dorsolithotomy position in Allen stirrups with antiembolic pressure stockings. Patients without prior laparotomy history had extraperitoneal approach with a distention balloon. If the patient had prior pelvic or abdominal surgery, a transperitoneal technique was used with sharp dissection to enter the space of Retzius after retrograde distention of the bladder with 300cc normal saline. A total of 4 No. 0 braided polyester double-armed sutures (ethibond) were sequentially passed through the endopelvic fascia/vaginal wall, excluding the vaginal epithelium in a figure-8 fashion, with each end then brought up through Cooper’s ligament on the ipsilateral side. Two sutures were placed on either side of the urethra, one at the level of the midurethra and the other at the level of the bladder neck, using the technique modified by Tanagho. Knots were sequentially tied extracorporeally. Gelfoam was placed between both sets of suspending sutures and the sidewall to accelerate scarring and fibrosis. Cyost was performed with indigo injection. Suprapubic catheter was placed. Endoclose needle used for fascial closure.
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Design Details
Question... Follow Up Answer Follow-up Answer
Country US
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Outcome Categories Reported Objective SUI
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Subjective SUI
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Quality of life
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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Urodynamic SUI
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RCT Comparison Category Sling vs. Burch
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Multicenter Yes
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Institution Type Academic hospital
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Number of surgeons performing procedures Not reported
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Surgeons' Training Urogynecology
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Residents or fellows performing surgery? Unclear/Not reported
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Study Quality (overall) B (fair)
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Overall Study Notes Underpowered due to early termination due to difficulty recruiting. ISI, IIQ, UDI, PGII were reported at 4-8yrs in the long term study
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Study Sponsor/Funding ... Other ... Grant-Minimally invasive surgery center
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Baseline Characteristics
Question TVT Burch, laparoscopic Retropubic synthetic L/S Burch Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 36 36
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Mean Age 53.3 54.8
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Post-Op Follow-Up Interval (Maximum) 4-8yrs 4-8yrs
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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective cure- uds      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed 31 32
Mean 1 6
Standard Deviation
.056


2 years

N Analyzed
Mean
Standard Deviation


4-8 years

N Analyzed
Mean
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI subjective cure-longterm UDI Q1      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation


4 years

N Analyzed 25 28
Mean 12 16
Standard Deviation
.51
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: subjective cure-Longterm ISI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation


4 years

N Analyzed 25 28
Mean 13 12
Standard Deviation
.43
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Reoperations-longterm      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


4 years

N Analyzed 33 33
Mean 1 1
Standard Deviation
.95


2 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed
Mean
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective-longterm pad use      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure ERROR vs. ERROR


0 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation


4 years

N Analyzed 25 28
Mean 7 7
Standard Deviation
.81
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: QOL-longterm PGII      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


4 years

N Analyzed 25 28
Mean 20 25
Standard Deviation
---


2 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed
Mean
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: De novo UDS DO      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed 31 32
Mean 6 2
Standard Deviation
.12


2 years

N Analyzed
Mean
Standard Deviation


4 years

N Analyzed
Mean
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: De novo UDS UUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


4 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed 31 32
Mean 1 0
Standard Deviation
.30


0 years

N Analyzed
Mean
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Longterm anticholinergic use      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation


4 years

N Analyzed 25 28
Mean 3 2
Standard Deviation
.55
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. TVT


4 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 33 33
Mean 29hr 33hr
Standard Deviation
.86
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Time of PCA usage      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


4 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 33 33
Mean 10 10
Standard Deviation
.97
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Longterm bothersome UI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


4 years

N Analyzed 25 28
Mean 2 3
Standard Deviation
.74


2 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation
Outcome: SUI objective cure-incontinence episodes per week      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


4-8 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed 16 17
Mean 0 .3
Standard Deviation
.83


1 years

N Analyzed 30 33
Mean .4 1.8
Standard Deviation


0 years

N Analyzed 33 33
Mean 16 16
Standard Deviation
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: SUI objective cure- pads per week      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed 33 33
Mean 3 (median) 3 (median)
Standard Deviation


1 years

N Analyzed 30 33
Mean 0 0
Standard Deviation


2 years

N Analyzed 16 17
Mean 0 0
Standard Deviation
.17


4-8 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation
Outcome: SUI subjective cure- UDI6 score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


4 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed 16 17
Mean 4 4
Standard Deviation
.69


1 years

N Analyzed 30 33
Mean 6 4
Standard Deviation


0 years

N Analyzed 33 33
Mean 40 42
Standard Deviation
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


4 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 33 33
Mean 141 165
Standard Deviation
.64
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed 33 33
Mean 141 210
Standard Deviation
<.001


1 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation


4 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation
Outcome: SPT removed      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed 33 33
Mean 5.2 4.9
Standard Deviation
.77


1 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation


4 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation
Outcome: Costs      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed 33 33
Mean 6059 6368
Standard Deviation
.63


1 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation


4 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation
Outcome: QOL-IIQ7      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


4 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed 16 17
Mean 95 90
Standard Deviation
.93


1 years

N Analyzed 30 33
Mean 49 38
Standard Deviation


0 years

N Analyzed 33 33
Mean 164 144
Standard Deviation
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: SUI subjective-VAS      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed 30 33
Mean 8.5 8.4
Standard Deviation
>.05


2 years

N Analyzed 16 17
Mean 8.2 9.0
Standard Deviation
>.05


4 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value
Outcome: operative time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


4 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 33 33
Mean 79 132
Standard Deviation
.003
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation
Outcome: Change in HCT      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed 33 33
Mean 5.2 6.5
Standard Deviation
.77


1 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation


4 years

N Analyzed
Mean
Standard Deviation


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic TVT (Gynecare): either local with IV sedation, or regional or general anesthesia. Upward-pass technique used. All received prophylactic antibiotics. High or low dorsolithotomy position. Antiembolic compression stockings. 18Fr catheter used during cse. 5mm suprapubic incisions made, approx 3cm lateral of midline just above the pubic bone. Retropubic injection of 10cc of 0.25% bupivacaine on each side. 1,5-2cm vertical incision at midurethra, 1 cm from the meatus. Catheter guide was used. Cysto performed after each pass. Cough stress test (local or regional anesthesia) or Crede maneuver (General anesthesia) was performed with 300cc in the bladder. Tape adjusted such that there was minimal leakage during this maneuver. Suprapubic tube was placed.
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2 L/S Burch Laparoscopic Burch: general anesthesia, prophylactic antibiotics given within 1 hr of surgery, low dorsolithotomy position in Allen stirrups with antiembolic pressure stockings. Patients without prior laparotomy history had extraperitoneal approach with a distention balloon. If the patient had prior pelvic or abdominal surgery, a transperitoneal technique was used with sharp dissection to enter the space of Retzius after retrograde distention of the bladder with 300cc normal saline. A total of 4 No. 0 braided polyester double-armed sutures (ethibond) were sequentially passed through the endopelvic fascia/vaginal wall, excluding the vaginal epithelium in a figure-8 fashion, with each end then brought up through Cooper’s ligament on the ipsilateral side. Two sutures were placed on either side of the urethra, one at the level of the midurethra and the other at the level of the bladder neck, using the technique modified by Tanagho. Knots were sequentially tied extracorporeally. Gelfoam was placed between both sets of suspending sutures and the sidewall to accelerate scarring and fibrosis. Cyost was performed with indigo injection. Suprapubic catheter was placed. Endoclose needle used for fascial closure.
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country US
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Sling Category Retropubic synthetic
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Multicenter? Yes
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Institution Type Academic hospital
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No. of Surgeons Performing the Procedures Unclear/Not reported
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Surgeons' Training Urogynecology
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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Adverse Event Ascertainment Active
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Unclear/Not reported
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Was the Clavien-Dindo Classification of Surgical Complications system used? No / Not reported
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Was a data safety monitoring board used? No / Not reported
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Study Sponsor/Funding ... Other ... Grant-Minimally invasive surgery center
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Comments (overall study) Underpowered
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Results & Comparisons