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A randomized comparison of a single-incision needleless (Contasure-needleless®) mini-sling versus an inside-out transobturator (Contasure-KIM®) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results.
Int Urogynecol J. 2018 09; 29(9):1387-1395.IU

Abstract

INTRODUCTION AND HYPOTHESIS

There is a shortage of reliable data on the efficiency of the under-investigated mini-slings to treat stress urinary incontinence (SUI). We aimed to compare the effectiveness of the single-incision needleless mini-sling (SIMS) with the transobturator inside-out mid-urethral sling (TOT).

MATERIALS AND METHODS

Two hundred one women with clinically proven SUI were included in this single-center prospective randomized trial. The patients were randomly allocated to the groups. All surgeries were done by the same single surgeon. Examinations were done by one other blinded surgeon. The patients were followed up for 24 months. Objective cure was defined as the absence of SUI and negative cough-stress test. Subjective cure was defined as no stress leakage of urine after surgery in a validated questionnaire. Failure of the surgery was defined as the need for reoperation. Every complaint was categorized by the IUGA/ICS Classification of Prosthesis-related Complications.

RESULTS

The objective (85.4% versus 89.9%, p = 0.362) and subjective (87.6% versus 89.9%, p = 0.636) cure rates were similar with the TOT and SIMS at the postoperative month 24, respectively. The mesh exposure ≤ 1 cm rate was 3.4% for both groups, and the mesh exposure > 1 cm rate was 2.2% for both groups. Overall failure rates were 3.4% and 2.2% for the TOT and SIMS group, respectively. No viscus organ perforation was noted. Complications with the SIMS procedure were less painful compared with TOT (p = 0.024).

CONCLUSIONS

Single-incision needleless mini-slings exhibited similar cure rates as the trans-obturator mid-urethral slings from both the patient and clinician points of view in 24 months of follow-up. Mini-slings resulted in significantly less postoperative pain than trans-obturator mid-urethral slings.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Dogan O
Department of Obstetrics and Gynecology, Health Sciences University, Sisli Hamidiye Etfal Research and Training Hospital, Binbasi Refikbey sk, No: 9/5 Sisli, Istanbul, Turkey. ozandogan02@hotmail.com.
Kaya AE
Department of Obstetrics and Gynecology, Duzce University Faculty of Medicine, Duzce, Turkey. , Arapciftligi mahallesi 2871.sok no:1/1 Guleryuz evleri, Duzce, Turkey.
Pulatoglu C
Department of Obstetrics and Gynecology, Bayburt Government Hospital, Bayburt, Turkey. , Singah mh, Ibni Sina cd., Bayburt Devlet Hastanesi Lojmani, F blok, D:1, 69000, Bayburt, Turkey.
Basbug A
Department of Obstetrics and Gynecology, Duzce University Faculty of Medicine, Duzce, Turkey. , Kultur mahallesi Mehmet Akif caddesi No 31/6, Duzce, Turkey.
Yassa M
Department of Obstetrics and Gynecology, Health Sciences University, Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey. , Sarikanarya sokak, Menekse apt. No.6/36 Kadikoy, Istanbul, Turkey.

MeSH

FemaleFollow-Up StudiesHumansProspective StudiesSuburethral SlingsTreatment OutcomeUrinary Incontinence, StressUrologic Surgical Procedures

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29549394

Clinical Trial Links

Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success

Citation

Dogan, Ozan, et al. "A Randomized Comparison of a Single-incision Needleless (Contasure-needleless®) Mini-sling Versus an Inside-out Transobturator (Contasure-KIM®) Mid-urethral Sling in Women With Stress Urinary Incontinence: 24-month Follow-up Results." International Urogynecology Journal, vol. 29, no. 9, 2018, pp. 1387-1395.
Dogan O, Kaya AE, Pulatoglu C, et al. A randomized comparison of a single-incision needleless (Contasure-needleless®) mini-sling versus an inside-out transobturator (Contasure-KIM®) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results. Int Urogynecol J. 2018;29(9):1387-1395.
Dogan, O., Kaya, A. E., Pulatoglu, C., Basbug, A., & Yassa, M. (2018). A randomized comparison of a single-incision needleless (Contasure-needleless®) mini-sling versus an inside-out transobturator (Contasure-KIM®) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results. International Urogynecology Journal, 29(9), 1387-1395. https://doi.org/10.1007/s00192-018-3624-4
Dogan O, et al. A Randomized Comparison of a Single-incision Needleless (Contasure-needleless®) Mini-sling Versus an Inside-out Transobturator (Contasure-KIM®) Mid-urethral Sling in Women With Stress Urinary Incontinence: 24-month Follow-up Results. Int Urogynecol J. 2018;29(9):1387-1395. PubMed PMID: 29549394.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized comparison of a single-incision needleless (Contasure-needleless®) mini-sling versus an inside-out transobturator (Contasure-KIM®) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results. AU - Dogan,Ozan, AU - Kaya,Aski Ellibes, AU - Pulatoglu,Cigdem, AU - Basbug,Alper, AU - Yassa,Murat, Y1 - 2018/03/16/ PY - 2017/12/05/received PY - 2018/03/01/accepted PY - 2018/3/20/pubmed PY - 2019/1/22/medline PY - 2018/3/18/entrez KW - Midurethral sling KW - Mini-slings KW - Single-incision tapes KW - Stress urinary incontinence KW - Tension-free vaginal tape KW - Urinary incontinence SP - 1387 EP - 1395 JF - International urogynecology journal JO - Int Urogynecol J VL - 29 IS - 9 N2 - INTRODUCTION AND HYPOTHESIS: There is a shortage of reliable data on the efficiency of the under-investigated mini-slings to treat stress urinary incontinence (SUI). We aimed to compare the effectiveness of the single-incision needleless mini-sling (SIMS) with the transobturator inside-out mid-urethral sling (TOT). MATERIALS AND METHODS: Two hundred one women with clinically proven SUI were included in this single-center prospective randomized trial. The patients were randomly allocated to the groups. All surgeries were done by the same single surgeon. Examinations were done by one other blinded surgeon. The patients were followed up for 24 months. Objective cure was defined as the absence of SUI and negative cough-stress test. Subjective cure was defined as no stress leakage of urine after surgery in a validated questionnaire. Failure of the surgery was defined as the need for reoperation. Every complaint was categorized by the IUGA/ICS Classification of Prosthesis-related Complications. RESULTS: The objective (85.4% versus 89.9%, p = 0.362) and subjective (87.6% versus 89.9%, p = 0.636) cure rates were similar with the TOT and SIMS at the postoperative month 24, respectively. The mesh exposure ≤ 1 cm rate was 3.4% for both groups, and the mesh exposure > 1 cm rate was 2.2% for both groups. Overall failure rates were 3.4% and 2.2% for the TOT and SIMS group, respectively. No viscus organ perforation was noted. Complications with the SIMS procedure were less painful compared with TOT (p = 0.024). CONCLUSIONS: Single-incision needleless mini-slings exhibited similar cure rates as the trans-obturator mid-urethral slings from both the patient and clinician points of view in 24 months of follow-up. Mini-slings resulted in significantly less postoperative pain than trans-obturator mid-urethral slings. SN - 1433-3023 UR - https://www.unboundmedicine.com/medline/citation/29549394/A_randomized_comparison_of_a_single_incision_needleless__Contasure_needleless®__mini_sling_versus_an_inside_out_transobturator__Contasure_KIM®__mid_urethral_sling_in_women_with_stress_urinary_incontinence:_24_month_follow_up_results_ DB - PRIME DP - Unbound Medicine ER -