Study Preview
Study Title and Description
Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial.
Key Questions Addressed
1 | Sling vs Comparator RCT outcomes (excluding AEs) | |
2 | Sling Adverse Events |
Primary Publication Information
Title | Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. |
Author | Barber MD, Kleeman S, Karram MM, Paraiso MF, Walters MD, Vasavada S, Ellerkmann M |
Country | -- |
Year | 2008 |
Numbers |
Pubmed ID: 18310363 9 (internal) |
Secondary Publication Information
UI | Title | Author | Country | Year | |
---|---|---|---|---|---|
Risk factors associated with failure 1 year after retropubic or transobturator midurethral slings. | Barber MD, Kleeman S, Karram MM, Paraiso MF, Ellerkmann M, Vasavada S, Walters MD | -- | 2008 |
Extraction Form: Sling vs Comparator RCT outcomes (excluding AEs)
Arms
Number | Title | Description | Comments |
---|---|---|---|
1 | TVT | Gynecare | |
2 | TOT-Monarc | AMS Monarc |
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.) | Symptomatic SUI | ||
Urodynamic SUI | |||
Intrinsic sphincter deficiency | |||
Mixed incontinence | |||
Concomitant prolapse surgery | |||
RCT Comparison Category | Retropubic vs. Obturator | ||
Multicenter | Yes | ||
Institution Type | Academic hospital | ||
Community hospital | |||
Number of surgeons performing procedures | Not reported | ||
Surgeons' Training | Urogynecology | ||
Residents or fellows performing surgery? | Yes | ||
Study Quality (overall) | A (good) | ||
Study Sponsor/Funding | Industry |
Baseline Characteristics
Question | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Total | Comments | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
No. Randomized | 88 | 82 | |||||||||
Mean Age | 52 | 53 | |||||||||
Post-Op Follow-Up Interval (Maximum) | 18.2 mo (mean) |
Results & Comparisons
Results Data
Outcome: "Normal bladder function" Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 88 | 82 | NS | |||
Counts | 47 | 47 | |||||
Percentage | 53.4 | 57.3 |
Outcome: Negative stress test Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 79 | 71 | NS | |||
Counts | 73 | 62 | |||||
Percentage | 92.4 | 87.3 |
Outcome: ISI-Dry Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 85 | 77 | NS | |||
Counts | 50 | 48 | |||||
Percentage | 58.8 | 62.3 |
Outcome: ISI-Slight Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 85 | 77 | NS | |||
Counts | 12 | 9 | |||||
Percentage | 14.1 | 11.7 |
Outcome: ISI-Moderate Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 85 | 77 | NS | |||
Counts | 10 | 13 | |||||
Percentage | 11.8 | 16.8 |
Outcome: ISI-Severe Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 85 | 77 | NS | |||
Counts | 13 | 7 | |||||
Percentage | 15.3 | 9.1 |
Outcome: PGII Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 82 | 75 | 0.88 | |||
Counts | 63 | 61 | |||||
Percentage | 76.8 | 81.3 |
Outcome: SUI symptoms Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 83 | 73 | 0.91 | |||
Counts | 12 | 11 | |||||
Percentage | 15 | 15 |
Outcome: UUI symptoms Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 81 | 72 | 0.61 | |||
Counts | 29 | 23 | |||||
Percentage | 36 | 32 |
Outcome: Time in OR Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 35 | 30 | 65 | |||
Mean | 29 | 28 | 0.45 | ||||
Standard Deviation | 10 | 7 |
Outcome: EBL Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 35 | 30 | 65 | |||
Median | 50 | 30 | 0.55 | ||||
Max | 500 | 200 | |||||
Min | 10 | 5 |
Outcome: Time in hospital-sling only Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 35 | 30 | 65 | |||
Median | 0 | 0 | 0.40 | ||||
Max | 2 | 2 | |||||
Min | 0 | 0 |
Outcome: Time in hospital-concom surg Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 53 | 52 | 105 | |||
Median | 2 | 1 | 0.21 | ||||
Max | 7 | 7 | |||||
Min | 0 | 0 |
Outcome: Days until catheter removed-sling only Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 35 | 30 | 65 | |||
Median | 0 | 1 | 0.52 | ||||
25th Percentile | 0 | 0 | |||||
75th Percentile | 2 | 2 |
Outcome: Days until catheter removed-concom surg Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 53 | 52 | 105 | |||
Median | 5 | 4 | 0.19 | ||||
25th Percentile | 1 | 1.8 | |||||
75th Percentile | 7 | 6.3 |
Outcome: Change in hematocrit Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 88 | 82 | 170 | |||
Mean | -6.5 | -5.2 | 0.14 | ||||
Standard Deviation | 4 | 4 |
Outcome: Pads per day Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Analyzed | 88 | 82 | 180 | |||
Median | 0 | 0 | 0.43 | ||||
Max | 5 | 6 | |||||
Min | 0 | 0 |
Outcome: Incontinence episodes per day Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Analyzed | 88 | 82 | 180 | |||
Median | 0 | 0 | 0.18 | ||||
Max | 16 | 7 | |||||
Min | 0 | 0 |
Outcome: PFDI summary score Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Analyzed | 88 | 82 | 180 | |||
Mean | -67 | -67 | NS | ||||
Standard Deviation | 44 | 44 |
Outcome: PFIQ-7 summary score Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Analyzed | 88 | 82 | 180 | |||
Mean | -42 | -42 | NS | ||||
Standard Deviation | 39 | 39 |
Outcome: SF-12 PCS summary score Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Analyzed | 88 | 82 | 180 | |||
Mean | 2 | 2 | NS | ||||
Standard Deviation | 9 | 9 |
Outcome: PISQ-12 summary score Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Analyzed | 88 | 82 | 180 | |||
Mean | 3 | 3 | NS | ||||
Standard Deviation | 5 | 5 |
Extraction Form: Sling Adverse Events
Arms
Number | Title | Description | Comments |
---|---|---|---|
1 | Retropubic synthetic | Gynecare TVT | |
2 | Transobturator synthetic | AMS Monarc |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Study Type | RCT | ||
Sling Category | Retropubic synthetic | ||
Obturator synthetic | |||
Adverse Event Ascertainment | Active | ||
Was the Clavien-Dindo Classification of Surgical Complications system used? | No / Not reported | ||
Was a data safety monitoring board used? | No / Not reported |
Results & Comparisons
Results Data
Outcome: "Normal bladder function" Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 88 | 82 | NS | |||
Counts | 47 | 47 | |||||
Percentage | 53.4 | 57.3 |
Outcome: Negative stress test Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 79 | 71 | NS | |||
Counts | 73 | 62 | |||||
Percentage | 92.4 | 87.3 |
Outcome: ISI-Dry Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 85 | 77 | NS | |||
Counts | 50 | 48 | |||||
Percentage | 58.8 | 62.3 |
Outcome: ISI-Slight Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 85 | 77 | NS | |||
Counts | 12 | 9 | |||||
Percentage | 14.1 | 11.7 |
Outcome: ISI-Moderate Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 85 | 77 | NS | |||
Counts | 10 | 13 | |||||
Percentage | 11.8 | 16.8 |
Outcome: ISI-Severe Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 85 | 77 | NS | |||
Counts | 13 | 7 | |||||
Percentage | 15.3 | 9.1 |
Outcome: PGII Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 82 | 75 | 0.88 | |||
Counts | 63 | 61 | |||||
Percentage | 76.8 | 81.3 |
Outcome: SUI symptoms Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 83 | 73 | 0.91 | |||
Counts | 12 | 11 | |||||
Percentage | 15 | 15 |
Outcome: UUI symptoms Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Enrolled | 81 | 72 | 0.61 | |||
Counts | 29 | 23 | |||||
Percentage | 36 | 32 |
Outcome: Time in OR Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 35 | 30 | 65 | |||
Mean | 29 | 28 | 0.45 | ||||
Standard Deviation | 10 | 7 |
Outcome: EBL Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 35 | 30 | 65 | |||
Median | 50 | 30 | 0.55 | ||||
Max | 500 | 200 | |||||
Min | 10 | 5 |
Outcome: Time in hospital-sling only Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 35 | 30 | 65 | |||
Median | 0 | 0 | 0.40 | ||||
Max | 2 | 2 | |||||
Min | 0 | 0 |
Outcome: Time in hospital-concom surg Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 53 | 52 | 105 | |||
Median | 2 | 1 | 0.21 | ||||
Max | 7 | 7 | |||||
Min | 0 | 0 |
Outcome: Days until catheter removed-sling only Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 35 | 30 | 65 | |||
Median | 0 | 1 | 0.52 | ||||
25th Percentile | 0 | 0 | |||||
75th Percentile | 2 | 2 |
Outcome: Days until catheter removed-concom surg Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 53 | 52 | 105 | |||
Median | 5 | 4 | 0.19 | ||||
25th Percentile | 1 | 1.8 | |||||
75th Percentile | 7 | 6.3 |
Outcome: Change in hematocrit Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
0 months |
N Analyzed | 88 | 82 | 170 | |||
Mean | -6.5 | -5.2 | 0.14 | ||||
Standard Deviation | 4 | 4 |
Outcome: Pads per day Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Analyzed | 88 | 82 | 180 | |||
Median | 0 | 0 | 0.43 | ||||
Max | 5 | 6 | |||||
Min | 0 | 0 |
Outcome: Incontinence episodes per day Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Analyzed | 88 | 82 | 180 | |||
Median | 0 | 0 | 0.18 | ||||
Max | 16 | 7 | |||||
Min | 0 | 0 |
Outcome: PFDI summary score Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Analyzed | 88 | 82 | 180 | |||
Mean | -67 | -67 | NS | ||||
Standard Deviation | 44 | 44 |
Outcome: PFIQ-7 summary score Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Analyzed | 88 | 82 | 180 | |||
Mean | -42 | -42 | NS | ||||
Standard Deviation | 39 | 39 |
Outcome: SF-12 PCS summary score Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Analyzed | 88 | 82 | 180 | |||
Mean | 2 | 2 | NS | ||||
Standard Deviation | 9 | 9 |
Outcome: PISQ-12 summary score Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TOT-Monarc | Retropubic synthetic | Transobturator synthetic | Comparison Measure | TVT vs. TOT-Monarc |
12 months |
N Analyzed | 88 | 82 | 180 | |||
Mean | 3 | 3 | NS | ||||
Standard Deviation | 5 | 5 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Retropubic synthetic | Transfusion post-op | Intraop | In-hospital | ND | ND | 1 | 88 | ND | 0.33 | ||
Transobturator synthetic | Intraop | In-hospital | ND | ND | 0 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Organ injury in OR (urethra, bladder, bowel) | Bladder injury | Intraop | In-hospital | ND | ND | 7 | 88 | ND | 0.02 | |
Transobturator synthetic | Intraop | In-hospital | ND | ND | 0 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Vaginal wall perforation | Intraop | In-hospital | ND | ND | 1 | 88 | ND | 0.33 | ||
Transobturator synthetic | Intraop | In-hospital | ND | ND | 0 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Organ injury in OR (urethra, bladder, bowel) | Urethral injury | Intraop | In-hospital | ND | ND | 0 | 88 | ND | 0.99 | |
Transobturator synthetic | Intraop | In-hospital | ND | ND | 0 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Organ injury in OR (urethra, bladder, bowel) | Ureteral injury | Intraop | In-hospital | ND | ND | 0 | 88 | ND | 0.54 | |
Transobturator synthetic | Intraop | In-hospital | ND | ND | 1 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Organ injury in OR (urethra, bladder, bowel) | Bowel injury | Intraop | In-hospital | ND | ND | 0 | 88 | ND | 0.99 | |
Transobturator synthetic | Intraop | In-hospital | ND | ND | 0 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Cardiac arrhythmia | Intraop | In-hospital | ND | ND | 1 | 88 | ND | 0.33 | ||
Transobturator synthetic | Intraop | In-hospital | ND | ND | 0 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Infection, other | Requiring antibiotics | <6wk | After discahrge | ND | ND | 11 | 88 | ND | 0.66 | |
Transobturator synthetic | <6wk | After discahrge | ND | ND | 13 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Infection, UTI | <6wk | After discahrge | ND | ND | 12 | 88 | ND | 0.89 | ||
Transobturator synthetic | <6wk | After discahrge | ND | ND | 11 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Cardiac/MI | <6wk | After discahrge | ND | ND | 0 | 88 | ND | 0.99 | ||
Transobturator synthetic | <6wk | After discahrge | ND | ND | 0 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Pulmonary complication | <6wk | After discahrge | ND | ND | 0 | 88 | ND | 0.48 | ||
Transobturator synthetic | <6wk | After discahrge | ND | ND | 1 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Ileus | <6wk | After discahrge | ND | ND | 0 | 88 | ND | 0.99 | ||
Transobturator synthetic | <6wk | After discahrge | ND | ND | 0 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Infection, other | Pelvic abscess | <6wk | After discahrge | ND | ND | 1 | 88 | ND | 0.99 | |
Transobturator synthetic | <6wk | After discahrge | ND | ND | 1 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Transfusion post-op | beyond intraop | <6wk | After discahrge | ND | ND | 1 | 88 | ND | 0.48 | |
Transobturator synthetic | <6wk | After discahrge | ND | ND | 0 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Pain, groin (new or different after surgery) | Leg/obturator complication | <6wk | After discahrge | ND | ND | 0 | 88 | ND | 0.99 | |
Transobturator synthetic | <6wk | After discahrge | ND | ND | 0 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Hospital readmission | <6wk | After discahrge | ND | ND | 0 | 88 | ND | 0.99 | ||
Transobturator synthetic | <6wk | After discahrge | ND | ND | 0 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | ER evaluation | <6wk | After discahrge | ND | ND | 2 | 88 | ND | 0.67 | ||
Transobturator synthetic | <6wk | After discahrge | ND | ND | 4 | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Pain, unspecified area (new or different after surgery) | VAS 0-10, median (range) | Day1 | In-hospital | ND | ND | 4 (0-9) | 88 | ND | 0.45 | |
Transobturator synthetic | Day1 | In-hospital | ND | ND | 4 (0-9) | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | VAS 0-10, median (range) | Day3 | After discahrge | ND | ND | 3 (0-8) | 88 | ND | 0.08 | ||
Transobturator synthetic | Day3 | After discahrge | ND | ND | 2 (0-8) | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | VAS 0-10, median (range) | Day7 | After discahrge | ND | ND | 2 (0-7) | 88 | ND | 0.11 | ||
Transobturator synthetic | Day7 | After discahrge | ND | ND | 1 (0-6) | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | VAS 0-10, median (range) | 6 wk | After discahrge | ND | ND | 0 (0-7) | 88 | ND | 0.38 | ||
Transobturator synthetic | 6 wk | After discahrge | ND | ND | 0 (0-3) | 82 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Retention requiring surgery | Sling release | >6wk | After discahrge | ND | ND | 1 | 85 | ND | NS | |
Transobturator synthetic | >6wk | After discahrge | ND | ND | 0 | 77 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Catheterization >6wk | >6wk | After discahrge | ND | ND | 4 | 85 | ND | NS | ||
Transobturator synthetic | >6wk | After discahrge | ND | ND | 2 | 77 | ND | ||||
Total | |||||||||||
Retropubic synthetic | Mesh erosion/extrusion/exposure/granulation tissue | 12mo | After discahrge | ND | ND | 5 | 88 | ND | 0.24 | ||
Transobturator synthetic | 12mo | After discahrge | ND | ND | 1 | 82 | ND | ||||
Total |