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Study Title and Description

Laparoscopic colposuspension versus vaginal suburethral slingplasty: a randomised prospective 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 colposuspension versus vaginal suburethral slingplasty: a randomised prospective trial.
Author Foote AJ., Maughan V., Carne C.
Country Australian National University, and Calvary Hospital, Canberra, Australian Capital Territory, Australia. ajfoote@bigpond.com
Year 2006
Numbers Pubmed ID: 17116057
694 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Sling vs Comparator RCT outcomes (excluding AEs)
Arms
Number Title Description Comments
1 SPARC The SPARC vaginal suburethral polypropylene sling was inserted using a 1-cm anterior vaginal incision with introduction of the mesh via two suprapubic 2 mm incisions. The mesh was inserted using a tension-free technique. The bladder was drained at the end of the procedure. A postvoid residual urine volume was performed after the first void to exclude retention.
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2 Burch, laparoscopic Laparoscopic colposuspension was performed using three ports (one umbilical 10 mm, and two lateral 5 mm). The anterior peritoneum was opened and an Ethibond suture was placed on each side to elevate the bladder neck to the iliopectineal ligament. A suprapubic catheter was inserted which was removed when two residual urine volumes were less than 100 mL.
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Australia
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Outcome Categories Reported Subjective SUI
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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Symptomatic SUI
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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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Community hospital
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Number of surgeons performing procedures 1
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Surgeons' Training Not reported
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Residents or fellows performing surgery? Unclear/Not reported
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Study Quality (overall) C (poor)
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Overall Study Notes Surgeon and pt could not be blinded due to nature of the different procedures. assessor not blinded I have several concerns regarding the internal validity of the study. The lack of allocation concealment, absence of a validated more objective primary outcome, high drop-out rate raise the question of possible significant bias. Although I could see why a B grading could be considered, I would probably downgrade it to a C. Also high dropout rate at 2yr 21 out of 48 for L/S Burch, and 18 out of49 for SPARC
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Study Sponsor/Funding ... Other ... not clear
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Baseline Characteristics
Question SPARC Burch, laparoscopic SPARC L/S Burch Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 49 48
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Mean Age 52.4y 51.2y
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Post-Op Follow-Up Interval (Maximum) 2y 2y
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Results & Comparisons


Results Data
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value
Outcome: SUI objective bladder diary      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC Burch, laparoscopic SPARC L/S Burch Comparison Measure SPARC vs. Burch, laparoscopic


0 years

N Analyzed 49 48
Mean 9.8 8.8
Standard Deviation


2 years

N Analyzed 31 27
Mean 3.5 2.1
Standard Deviation
NS
Within-Arm Comparisons
Comparison Measure SPARC Burch, laparoscopic SPARC L/S Burch
0 years vs. 2 years N Enrolled
Mean Difference
Standard Deviation <.001 <.001
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC Burch, laparoscopic SPARC L/S Burch Comparison Measure SPARC vs. Burch, laparoscopic


0 years

N Analyzed 49 48
Mean 82.6 104.3
Standard Deviation
<.01


2 years

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


2 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 49 48
Mean 30 48
Standard Deviation
<.001
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: Time in Hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC Burch, laparoscopic SPARC L/S Burch Comparison Measure SPARC vs. Burch, laparoscopic


0 years

N Analyzed 49 48
Mean 1.5 4.0
Standard Deviation
<.001


2 years

N Analyzed
Mean
Standard Deviation
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 SPARC Burch, laparoscopic SPARC L/S Burch Comparison Measure SPARC vs. Burch, laparoscopic


2 years

N Analyzed 31 27
Mean 5.9 5.6
Standard Deviation
NS


0 years

N Analyzed 49 48
Mean 2.2 1.7
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: Time to normal activity      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC Burch, laparoscopic SPARC L/S Burch Comparison Measure SPARC vs. Burch, laparoscopic


0 years

N Analyzed 49 48
Mean 2.8 3.6
Standard Deviation
<.01


2 years

N Analyzed
Mean
Standard Deviation


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 SPARC The SPARC vaginal suburethral polypropylene sling was inserted using a 1-cm anterior vaginal incision with introduction of the mesh via two suprapubic 2 mm incisions. The mesh was inserted using a tension-free technique. The bladder was drained at the end of the procedure. A postvoid residual urine volume was performed after the first void to exclude retention.
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2 L/S Burch Laparoscopic colposuspension was performed using three ports (one umbilical 10 mm, and two lateral 5 mm). The anterior peritoneum was opened and an Ethibond suture was placed on each side to elevate the bladder neck to the iliopectineal ligament. A suprapubic catheter was inserted which was removed when two residual urine volumes were less than 100 mL.
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country Australia
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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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Community hospital
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No. of Surgeons Performing the Procedures 1
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Surgeons' Training Not reported
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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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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 ... unknown
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Results & Comparisons


Results Data
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value
Outcome: SUI objective bladder diary      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC Burch, laparoscopic SPARC L/S Burch Comparison Measure SPARC vs. Burch, laparoscopic


0 years

N Analyzed 49 48
Mean 9.8 8.8
Standard Deviation


2 years

N Analyzed 31 27
Mean 3.5 2.1
Standard Deviation
NS
Within-Arm Comparisons
Comparison Measure SPARC Burch, laparoscopic SPARC L/S Burch
0 years vs. 2 years N Enrolled
Mean Difference
Standard Deviation <.001 <.001
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC Burch, laparoscopic SPARC L/S Burch Comparison Measure SPARC vs. Burch, laparoscopic


0 years

N Analyzed 49 48
Mean 82.6 104.3
Standard Deviation
<.01


2 years

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


2 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 49 48
Mean 30 48
Standard Deviation
<.001
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: Time in Hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC Burch, laparoscopic SPARC L/S Burch Comparison Measure SPARC vs. Burch, laparoscopic


0 years

N Analyzed 49 48
Mean 1.5 4.0
Standard Deviation
<.001


2 years

N Analyzed
Mean
Standard Deviation
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 SPARC Burch, laparoscopic SPARC L/S Burch Comparison Measure SPARC vs. Burch, laparoscopic


2 years

N Analyzed 31 27
Mean 5.9 5.6
Standard Deviation
NS


0 years

N Analyzed 49 48
Mean 2.2 1.7
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: Time to normal activity      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC Burch, laparoscopic SPARC L/S Burch Comparison Measure SPARC vs. Burch, laparoscopic


0 years

N Analyzed 49 48
Mean 2.8 3.6
Standard Deviation
<.01


2 years

N Analyzed
Mean
Standard Deviation

Adverse Events
Arm or Total Title Description Follow-up time In-hospital or After discharge Is event serious? Reported definition of serious event Number affected Number at risk (analyzed) Difference between 2 slings (eg, OR/RR or %, with 95% CI) Reported P value between slings Comments
SPARC Mesh erosion/extrusion/exposure/granulation tissue 1 49
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L/S Burch 0 48
Total
SPARC Organ injury in OR (urethra, bladder, bowel) bladder perforation 5 49
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L/S Burch 1 48
Total
SPARC Transfusion post-op 0 49
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L/S Burch 0 48
Total
SPARC retention requiring catheter At six months there were no cases of voiding difficulty in either group 0 49
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L/S Burch 0 48
Total
SPARC
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L/S Burch
Total