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Long-term outcomes of the Ajust® Adjustable Single-Incision Sling for the treatment of stress urinary incontinence

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Abstract

Introduction and hypothesis

The aim of this study was to evaluate the effectiveness and overall safety of the Ajust® Adjustable Single-Incision Sling in the treatment of female stress urinary incontinence.

Methods

This was a prospective, multicenter study conducted in women diagnosed with stress urinary incontinence. The Ajust® Sling was implanted and patients were followed postoperatively for up to 29 months. Evaluations were performed to assess postoperative rate of continence, complications, and patient quality of life (QOL).

Results

From November 2008 through May 2009, 52 patients were enrolled and underwent a procedure to implant the Ajust® Sling. Overall, 86.3 % of the patients who successfully received the Ajust® Sling demonstrated total restoration or improvement of continence at the last study visit. QOL scores related to global bladder feeling and lifestyle improved. Only one patient reported the occurrence of mild pain which resolved without treatment or sequelae.

Conclusions

In long-term follow-up, the Ajust® Sling was safe and effective, restoring or improving continence in 86.3 % of patients.

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Abbreviations

Ajust® Sling:

Ajust® Adjustable Single-Incision Sling

BMI:

Body mass index

CST:

Cough stress test

PGI-I:

Patient Global Impression of Improvement

PPIUS:

Patient Perception of Intensity of Urgency Scale

PVR:

Post-void residual

QOL:

Quality of life

SUI:

Stress urinary incontinence

TVT:

Tension-free vaginal tape

UUI:

Urgency urinary incontinence

VAS:

Visual analogue scale

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Acknowledgements

We thank all of the patients as well as the secretarial, nursing, and medical staff of the participating hospitals and the gynecologists and urologists for their cooperation. Special thanks to Vincent Lucente, Allentown PA, for his help in introduction of this method.

Funding

None received from C. R. Bard.

Conflicts of interest

G. Naumann, T. Hagemeier and S. Zachmann have received honoraria from C.R. Bard for lectures.

Author information

Authors and Affiliations

  1. Department of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg University Mainz, Langenbeckstrasse 1, 55131, Mainz, Germany

    Gert Naumann, Stefan Albrich, Christine Skala, Rosa Laterza & Heinz Koelbl

  2. Pelvic Floor Center SRH Hospital, Suhl, Germany

    Thomas Hagemeier

  3. Department of Obstetrics and Gynecology, Hospital Männedorf, Männedorf, Switzerland

    Stefan Zachmann

  4. Pelvic Floor Center, Hufeland Hospital, Bad Langensalza, Germany

    Aktham Al-Ani

  5. Corporate Clinical Affairs, C. R. Bard, Murray Hill, NJ, USA

    Misti Linaberry

Authors
  1. Gert Naumann
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  2. Thomas Hagemeier
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  3. Stefan Zachmann
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  4. Aktham Al-Ani
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  6. Christine Skala
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Corresponding author

Correspondence to Gert Naumann.

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Naumann, G., Hagemeier, T., Zachmann, S. et al. Long-term outcomes of the Ajust® Adjustable Single-Incision Sling for the treatment of stress urinary incontinence. Int Urogynecol J 24, 231–239 (2013). https://doi.org/10.1007/s00192-012-1843-7

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  • DOI: https://doi.org/10.1007/s00192-012-1843-7

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