Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial.

MedStar author(s):
Citation: Obstetrics & Gynecology. 119(2 Pt 1):328-37, 2012 Feb.PMID: 22270285Institution: MedStar Washington Hospital CenterDepartment: Obstetrics and Gynecology/Female Pelvic Medicine and Reconstructive SurgeryForm of publication: Journal ArticleMedline article type(s): Comparative Study | Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Suburethral Slings | *Urinary Incontinence, Stress/su [Surgery] | *Urologic Surgical Procedures/mt [Methods] | Adult | Aged | Chi-Square Distribution | Confidence Intervals | Female | Follow-Up Studies | Humans | Kaplan-Meier Estimate | Middle Aged | Pain, Postoperative/et [Etiology] | Severity of Illness Index | Statistics, Nonparametric | Suburethral Slings/ae [Adverse Effects] | Treatment Outcome | Urinary Bladder/in [Injuries] | UrodynamicsYear: 2012Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006ISSN:
  • 0029-7844
Name of journal: Obstetrics and gynecologyAbstract: 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).All authors: Amundsen CL, Barber MD, Ellerkmann M, Foundation for Female Health Awareness Research Network, Iglesia CB, Jelovsek JE, Karram MM, Rardin CR, Sokol AI, Toglia M, Weidner ACFiscal year: FY2012Digital Object Identifier: Date added to catalog: 2013-09-17
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 22270285 Available 22270285

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006

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).

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