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Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial.
Int Urogynecol J. 2019 09; 30(9):1465-1473.IU

Abstract

INTRODUCTION AND HYPOTHESIS

The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence.

METHODS

This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years.

RESULTS

In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS.

CONCLUSIONS

Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Skane University Hospital, Lund, Sweden. alexandridisv@gmail.com. Faculty of Medicine, Lund University, Lund, Sweden. alexandridisv@gmail.com. Department of Obstetrics and Gynecology, Skane University Hospital, Jan Waldenströms gata 47, 214 66, Malmö, Sweden. alexandridisv@gmail.com.Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark. Department of Clinical Research, University of Southern Denmark, Odense, Denmark.Faculty of Medicine, Lund University, Lund, Sweden. Center for Primary Healthcare Research, Clinical Research Center, Malmö, Sweden.Department of Obstetrics and Gynecology, Skane University Hospital, Lund, Sweden. Faculty of Medicine, Lund University, Lund, Sweden.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

31222572

Citation

Alexandridis, Vasileios, et al. "Adjustable Mini-sling Compared With Conventional Mid-urethral Slings in Women With Urinary Incontinence: a 3-year Follow-up of a Randomized Controlled Trial." International Urogynecology Journal, vol. 30, no. 9, 2019, pp. 1465-1473.
Alexandridis V, Rudnicki M, Jakobsson U, et al. Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial. Int Urogynecol J. 2019;30(9):1465-1473.
Alexandridis, V., Rudnicki, M., Jakobsson, U., & Teleman, P. (2019). Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial. International Urogynecology Journal, 30(9), 1465-1473. https://doi.org/10.1007/s00192-019-04004-w
Alexandridis V, et al. Adjustable Mini-sling Compared With Conventional Mid-urethral Slings in Women With Urinary Incontinence: a 3-year Follow-up of a Randomized Controlled Trial. Int Urogynecol J. 2019;30(9):1465-1473. PubMed PMID: 31222572.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial. AU - Alexandridis,Vasileios, AU - Rudnicki,Martin, AU - Jakobsson,Ulf, AU - Teleman,Pia, Y1 - 2019/06/20/ PY - 2019/03/01/received PY - 2019/05/28/accepted PY - 2019/6/22/pubmed PY - 2020/4/9/medline PY - 2019/6/22/entrez KW - Mid-urethral sling KW - Mini-sling KW - Single-incision sling KW - Stress urinary incontinence SP - 1465 EP - 1473 JF - International urogynecology journal JO - Int Urogynecol J VL - 30 IS - 9 N2 - INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. METHODS: This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years. RESULTS: In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS. CONCLUSIONS: Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes. SN - 1433-3023 UR - https://www.unboundmedicine.com/medline/citation/31222572/Adjustable_mini_sling_compared_with_conventional_mid_urethral_slings_in_women_with_urinary_incontinence:_a_3_year_follow_up_of_a_randomized_controlled_trial_ L2 - https://dx.doi.org/10.1007/s00192-019-04004-w DB - PRIME DP - Unbound Medicine ER -