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Multicenter prospective randomized study of single-incision mini-sling vs tension-free vaginal tape-obturator in management of female stress urinary incontinence: a minimum of 1-year follow-up.
Urology. 2013 Sep; 82(3):552-9.U

Abstract

OBJECTIVE

To compare an adjustable anchored single incision mini-sling (SIMS-Ajust) vs tension-free vaginal tape-obturator (TVT-O) in the management of female stress urinary incontinence (SUI) with a minimum of 1-year follow-up.

METHODS

We conducted a multicenter prospective randomized control trial (RCT) performed in 6 United Kingdom centers in the period between October 2009 and October 2011. Women were randomized to either SIMS-Ajust (C. R. Bard) performed under local anesthesia or TVT-O (Ethicon Inc.) performed under general anesthesia. Women completed validated symptom-severity and quality of life (QOL) questionnaires preoperatively and at 1 year. In addition, women completed the Patient Global Impression of Improvement (PGI-I) and underwent the Cough Stress Test (CST) at 1 year. The primary outcome at 12 months was the patient-reported success rate. Secondary outcomes included objective cure, reoperation rate, impact on women's urinary symptoms, QOL, and sexual function. Data was analyzed using SPSS-19 with significance level set at 5%.

RESULTS

One hundred thirty-seven women were randomized into 2 groups: the SIMS-Ajust group (n = 69) and the TVT-O group (n = 68). At 1 year, there were no significant differences in the patient-reported success rate (odds ratio [OR] 0.895, 95% confidence interval [CI] 0.344-2.330, P = 1.000), objectives success rate (OR 0.929, 95% CI 0.382-2.258, P = 1.00), and reoperation rates (OR 0.591, 95% CI 0.136-2.576, P = .721) between the SIMS-Ajust and the TVT-O groups, respectively. A comparable number of women reported cure/improvement of urgency (P = .658), significant improvement in QOL (P = .190), and sexual function (P = .699) in both groups.

CONCLUSION

Adjustable-anchored SIMS (Ajust) is associated with comparable patient-reported and objective success rates when compared to standard midurethral sling (SMUS, TVT-O) at a minimum of 1-year follow-up. The results should be interpreted with caution due to the relatively small cohort size. Long-term follow-up of this RCT is required to ascertain the durability of these results.

Authors+Show Affiliations

University of Aberdeen, Aberdeen, Scotland, UK.No 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

23845666

Citation

Mostafa, Alyaa, et al. "Multicenter Prospective Randomized Study of Single-incision Mini-sling Vs Tension-free Vaginal Tape-obturator in Management of Female Stress Urinary Incontinence: a Minimum of 1-year Follow-up." Urology, vol. 82, no. 3, 2013, pp. 552-9.
Mostafa A, Agur W, Abdel-All M, et al. Multicenter prospective randomized study of single-incision mini-sling vs tension-free vaginal tape-obturator in management of female stress urinary incontinence: a minimum of 1-year follow-up. Urology. 2013;82(3):552-9.
Mostafa, A., Agur, W., Abdel-All, M., Guerrero, K., Lim, C., Allam, M., Yousef, M., N'Dow, J., & Abdel-Fattah, M. (2013). Multicenter prospective randomized study of single-incision mini-sling vs tension-free vaginal tape-obturator in management of female stress urinary incontinence: a minimum of 1-year follow-up. Urology, 82(3), 552-9. https://doi.org/10.1016/j.urology.2013.02.080
Mostafa A, et al. Multicenter Prospective Randomized Study of Single-incision Mini-sling Vs Tension-free Vaginal Tape-obturator in Management of Female Stress Urinary Incontinence: a Minimum of 1-year Follow-up. Urology. 2013;82(3):552-9. PubMed PMID: 23845666.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicenter prospective randomized study of single-incision mini-sling vs tension-free vaginal tape-obturator in management of female stress urinary incontinence: a minimum of 1-year follow-up. AU - Mostafa,Alyaa, AU - Agur,Wael, AU - Abdel-All,Mohamed, AU - Guerrero,Karen, AU - Lim,Chu, AU - Allam,Mohamed, AU - Yousef,Mohamed, AU - N'Dow,James, AU - Abdel-Fattah,Mohamed, Y1 - 2013/07/09/ PY - 2012/12/10/received PY - 2013/02/20/revised PY - 2013/02/26/accepted PY - 2013/7/13/entrez PY - 2013/7/13/pubmed PY - 2013/12/18/medline SP - 552 EP - 9 JF - Urology JO - Urology VL - 82 IS - 3 N2 - OBJECTIVE: To compare an adjustable anchored single incision mini-sling (SIMS-Ajust) vs tension-free vaginal tape-obturator (TVT-O) in the management of female stress urinary incontinence (SUI) with a minimum of 1-year follow-up. METHODS: We conducted a multicenter prospective randomized control trial (RCT) performed in 6 United Kingdom centers in the period between October 2009 and October 2011. Women were randomized to either SIMS-Ajust (C. R. Bard) performed under local anesthesia or TVT-O (Ethicon Inc.) performed under general anesthesia. Women completed validated symptom-severity and quality of life (QOL) questionnaires preoperatively and at 1 year. In addition, women completed the Patient Global Impression of Improvement (PGI-I) and underwent the Cough Stress Test (CST) at 1 year. The primary outcome at 12 months was the patient-reported success rate. Secondary outcomes included objective cure, reoperation rate, impact on women's urinary symptoms, QOL, and sexual function. Data was analyzed using SPSS-19 with significance level set at 5%. RESULTS: One hundred thirty-seven women were randomized into 2 groups: the SIMS-Ajust group (n = 69) and the TVT-O group (n = 68). At 1 year, there were no significant differences in the patient-reported success rate (odds ratio [OR] 0.895, 95% confidence interval [CI] 0.344-2.330, P = 1.000), objectives success rate (OR 0.929, 95% CI 0.382-2.258, P = 1.00), and reoperation rates (OR 0.591, 95% CI 0.136-2.576, P = .721) between the SIMS-Ajust and the TVT-O groups, respectively. A comparable number of women reported cure/improvement of urgency (P = .658), significant improvement in QOL (P = .190), and sexual function (P = .699) in both groups. CONCLUSION: Adjustable-anchored SIMS (Ajust) is associated with comparable patient-reported and objective success rates when compared to standard midurethral sling (SMUS, TVT-O) at a minimum of 1-year follow-up. The results should be interpreted with caution due to the relatively small cohort size. Long-term follow-up of this RCT is required to ascertain the durability of these results. SN - 1527-9995 UR - https://www.unboundmedicine.com/medline/citation/23845666/Multicenter_prospective_randomized_study_of_single_incision_mini_sling_vs_tension_free_vaginal_tape_obturator_in_management_of_female_stress_urinary_incontinence:_a_minimum_of_1_year_follow_up_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0090-4295(13)00562-1 DB - PRIME DP - Unbound Medicine ER -