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Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial.
Obstet Gynecol. 2012 Feb; 119(2 Pt 1):328-37.OG

Abstract

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.

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.

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).

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.

Authors+Show Affiliations

Cleveland Clinic, Cleveland, Ohio, USA. barberm2@ccf.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22270285

Citation

Barber, Matthew D., et al. "Single-incision Mini-sling Compared With Tension-free Vaginal Tape for the Treatment of Stress Urinary Incontinence: a Randomized Controlled Trial." Obstetrics and Gynecology, vol. 119, no. 2 Pt 1, 2012, pp. 328-37.
Barber MD, Weidner AC, Sokol AI, et al. Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2012;119(2 Pt 1):328-37.
Barber, M. D., Weidner, A. C., Sokol, A. I., Amundsen, C. L., Jelovsek, J. E., Karram, M. M., Ellerkmann, M., Rardin, C. R., Iglesia, C. B., & Toglia, M. (2012). Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstetrics and Gynecology, 119(2 Pt 1), 328-37. https://doi.org/10.1097/AOG.0b013e318242a849
Barber MD, et al. Single-incision Mini-sling Compared With Tension-free Vaginal Tape for the Treatment of Stress Urinary Incontinence: a Randomized Controlled Trial. Obstet Gynecol. 2012;119(2 Pt 1):328-37. PubMed PMID: 22270285.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. AU - Barber,Matthew D, AU - Weidner,Alison C, AU - Sokol,Andrew I, AU - Amundsen,Cindy L, AU - Jelovsek,J Eric, AU - Karram,Mickey M, AU - Ellerkmann,Mark, AU - Rardin,Charles R, AU - Iglesia,Cheryl B, AU - Toglia,Marc, AU - ,, PY - 2012/1/25/entrez PY - 2012/1/25/pubmed PY - 2012/6/12/medline SP - 328 EP - 37 JF - Obstetrics and gynecology JO - Obstet Gynecol VL - 119 IS - 2 Pt 1 N2 - 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. 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. 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). 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. SN - 1873-233X UR - https://www.unboundmedicine.com/medline/citation/22270285/Single_incision_mini_sling_compared_with_tension_free_vaginal_tape_for_the_treatment_of_stress_urinary_incontinence:_a_randomized_controlled_trial_ L2 - https://doi.org/10.1097/AOG.0b013e318242a849 DB - PRIME DP - Unbound Medicine ER -