Study Preview
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) | |
2 | Sling Adverse Events |
Primary Publication Information
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 |
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. | |
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 Cooperâ€™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. |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Country | US | ||
Outcome Categories Reported | Objective SUI | ||
Subjective SUI | |||
Quality of life | |||
OR outcomes/complications (not "AEs") | |||
Population (reason for surgery etc.) | Urodynamic SUI | ||
RCT Comparison Category | Sling vs. Burch | ||
Multicenter | Yes | ||
Institution Type | Academic hospital | ||
Number of surgeons performing procedures | Not reported | ||
Surgeons' Training | Urogynecology | ||
Residents or fellows performing surgery? | Unclear/Not reported | ||
Study Quality (overall) | B (fair) | ||
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 | ||
Study Sponsor/Funding ... | Other ... | Grant-Minimally invasive surgery center |
Baseline Characteristics
Question | TVT | Burch, laparoscopic | Retropubic synthetic | L/S Burch | Total | Comments | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
No. Randomized | 36 | 36 | |||||||||
Mean Age | 53.3 | 54.8 | |||||||||
Post-Op Follow-Up Interval (Maximum) | 4-8yrs | 4-8yrs |
Results & Comparisons
Results Data
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 | |||||||
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 |
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 |
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 |
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 |
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 | |||||||
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 | |||||||
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 | |||||||
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 |
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 |
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 |
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 | |||||||
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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. | |
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 Cooperâ€™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. |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Study Type | RCT | ||
Study Country | US | ||
Sling Category | Retropubic synthetic | ||
Multicenter? | Yes | ||
Institution Type | Academic hospital | ||
No. of Surgeons Performing the Procedures | Unclear/Not reported | ||
Surgeons' Training | Urogynecology | ||
Residents or Fellows Performing the Surgery? | Unclear/Not reported | ||
Adverse Event Ascertainment | Active | ||
Unclear/Not reported | |||
Was the Clavien-Dindo Classification of Surgical Complications system used? | No / Not reported | ||
Was a data safety monitoring board used? | No / Not reported | ||
Study Sponsor/Funding ... | Other ... | Grant-Minimally invasive surgery center | |
Comments (overall study) | Underpowered |
Results & Comparisons