TY  - BOOK
AU  - Iglesia, Cheryl B
AU  - Sokol, Andrew I
TI  - Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial
SN  - 0029-7844
PY  - 2012///
KW  - *Suburethral Slings
KW  - *Urinary Incontinence, Stress/su [Surgery]
KW  - *Urologic Surgical Procedures/mt [Methods]
KW  - Adult
KW  - Aged
KW  - Chi-Square Distribution
KW  - Confidence Intervals
KW  - Female
KW  - Follow-Up Studies
KW  - Humans
KW  - Kaplan-Meier Estimate
KW  - Middle Aged
KW  - Pain, Postoperative/et [Etiology]
KW  - Severity of Illness Index
KW  - Statistics, Nonparametric
KW  - Suburethral Slings/ae [Adverse Effects]
KW  - Treatment Outcome
KW  - Urinary Bladder/in [Injuries]
KW  - Urodynamics
KW  - MedStar Washington Hospital Center
KW  - Obstetrics and Gynecology/Female Pelvic Medicine and Reconstructive Surgery
KW  - Comparative Study
KW  - Journal Article
KW  - Multicenter Study
KW  - Randomized Controlled Trial
KW  - Research Support, Non-U.S. Gov't
N1  - Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006
N2  - CONCLUSION: The mini-sling placed in the "U" position results in similar subjective cure rates to TVT 1 year after surgery but postoperative incontinence severity is greater with the mini-sling than with TVT; LEVEL OF EVIDENCE: I; METHODS: Women with urodynamic stress incontinence with or without genital prolapse were randomized to receive a mini-sling or TVT (N=263). Those randomized to the mini-sling received two "sham" suprapubic incisions to facilitate blinding. The primary outcome was subjective cure (absence of any urinary incontinence or retreatment) as assessed at 1 year. This trial was a noninferiority study design; OBJECTIVE: To compare the efficacy of a single-incision mini-sling, placed in the "U" position, with tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence; RESULTS: Participants receiving the mini-sling were less likely to have a bladder injury (0.8% compared with 4.8%; P=.0.46), more likely to be discharged without a catheter (78.5% compared with 63%; P=.008), and had less pain for postoperative days 1-3. One year after surgery, the rate of cure was similar between treatment groups (mini-sling 55.8% compared with TVT 60.6%; mean difference, 4.8%; 95% confidence interval, -16.7 to +7.2); however, this did not meet our predefined noninferiority criteria of -12%. Incontinence severity at 1 year was greater with the mini-sling than with TVT (mean severity score +/- SD: 2.2+/-2.7 compared with 1.5+/-1.9; P=.015), resulting predominantly from a higher proportion of participants with "severe" incontinence postoperatively (16% compared with 5%; P=.025)
UR  - http://dx.doi.org/10.1097/AOG.0b013e318242a849
ER  -