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Miniarc® single-incision sling for treatment of stress urinary incontinence: 2-year clinical outcomes

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Abstract

Introduction and hypothesis

We report 2-year data on the effectiveness and safety of the MiniArc single-incision sling in women with stress urinary incontinence.

Methods

This multi-center, prospective, single-arm, industry-sponsored study measured the effectiveness of the MiniArc sling via quantitative (cough stress test and 1-h pad weight test) and qualitative (Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form) measurements. The objective efficacy rate was defined as the number of patients with a negative cough stress test or 1-h pad weight test ≤ 1 g at 2 years. The subjective efficacy rate was determined by patient responses to the UDI-6 question # 3, “Do you experience, and if so, how much are you bothered by urine leakage related to physical activity, coughing, or sneezing?” Secondary objectives were to evaluate procedural variables of implantation and long-term safety.

Results

One hundred and eighty women with a mean age of 51.1 years were implanted in the study. Mean procedure time, blood loss, and length of stay were 11.0 min, 41.7 mL and 9.5 h respectively. At 2 years, 142 patients were available for analysis. The objective efficacy rates for the cough stress test (CST) and pad weight test (PWT) were 84.5 % and 80.1 % respectively and the subjective efficacy rate was 92.9 %. Median Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form scores showed statistically significant improvement (p < .001). The most common adverse events included UTI (4.8 %), constipation (3.7 %), and temporary urinary retention (3.2 %).

Conclusion

MiniArc is a safe and effective surgical procedure for the treatment of SUI in women with follow-up through 2 years.

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Abbreviations

AE:

Adverse events

BMI:

Body Mass Index

CST:

Cough stress test

EBL:

Estimated blood loss

EC:

Ethics Committee

IIQ-7:

Incontinence Impact Questionnaire-Short form

IRB:

Institutional Review Board

LFCF:

Last failure carried forward

LOS:

Length of stay

MOS:

Months

PWT:

One-hour Pad Weight Test

QoL:

Quality of life

SUI:

Stress urinary incontinence

UDI-6:

Urogenital Distress Inventory-Short form

USI:

Urodynamic stress incontinence

WBFPS:

Wong-Baker Faces Pain Scale

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Acknowledgements

Study investigators who also participated in the study: Dirk De Ridder, Christopher Graham, Kristi Keil, Christopher Klingele, John Miklos, Peter Pommerville, James Presthus, Stewart Pringle, Paul Siami, Jeffrey Snyder, Suzette Sutherland, Douglas VanDrie, and Stuart Weprin.

Conflicts of interest

This study was sponsored by American Medical Systems, which provided financial support for running the study, the coordination of data collection across the sites, and data analysis.

M.J. Kennelly: AMS (study support, consultant honoraria), Bard (study support, consultant honoraria), Coloplast (study support, consultant honoraria), Ethicon Women’s Health & Urology (study support, consultant honoraria)

R. Moore: AMS (study support, consultant honoraria)

J.N. Nguyen: AMS (study support, consultant honoraria)

J. Lukban: AMS (study support, consultant honoraria), Coloplast (study support, consultant honoraria), Novasys (consultant honoraria)

S. Siegel: AMS (study support, consultant honoraria), SUFU (Board member), NCS (Board member)

Author information

Authors and Affiliations

  1. Department of Urology, Carolinas Medical Center, Charlotte, NC, USA

    Michael J Kennelly

  2. Atlanta Urogynecology Associates, Alpharetta, GA, USA

    Robert Moore

  3. Female Pelvic Medicine & Reconstruction Surgery Obstetrics & Gynecology, Southern California Permanente Medical Group, Downey, CA, USA

    John N. Nguyen

  4. Eastern Virginia Medical School, Norfolk, VA, USA

    James Lukban

  5. Metro Urology, St. Paul, MN, USA

    Steven Siegel

  6. McKay Department of Urology, 1023 Edgehill Road South, Charlotte, NC, 28207, USA

    Michael J Kennelly

Authors
  1. Michael J Kennelly
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  2. Robert Moore
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  3. John N. Nguyen
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  4. James Lukban
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  5. Steven Siegel
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Corresponding author

Correspondence to Michael J Kennelly.

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Kennelly, M.J., Moore, R., Nguyen, J.N. et al. Miniarc® single-incision sling for treatment of stress urinary incontinence: 2-year clinical outcomes. Int Urogynecol J 23, 1285–1291 (2012). https://doi.org/10.1007/s00192-012-1734-y

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  • DOI: https://doi.org/10.1007/s00192-012-1734-y

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