Top

Published in:

01-02-2011 | Original Article

Short-term outcomes with the Ajust™ system: a new single incision sling for the treatment of stress urinary incontinence

Authors: Michele Meschia, Pietro Barbacini, Roberto Baccichet, Arturo Buonaguidi, Marco Maffiolini, Luisa Ricci, Chiara Braghin, Valentina Brusati, Chiara Dell’Utri, Lorenzo Spreafico

Published in: International Urogynecology Journal | Issue 2/2011

Abstract

Introduction and hypothesis

To evaluate the efficacy and safety of the minimally invasive Ajust™ system in the treatment of stress urinary incontinence.

Methods

This was a prospective multicentre study. All patients with primary urodynamic stress urinary incontinence were prospectively selected to receive the Ajust™ procedure. The International Consultation on Incontinence-Short Form (ICI-SF), Women Irritative Prostate Symptoms Score (W-IPSS), PGI-S, and PGI-I questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure patient's perception of incontinence severity and improvement.

Results

From January 2009 to October 2009, 111 consecutive subjects were enrolled in the study. At 6 months, 102 were available for outcomes analysis. The subjective and objective cure rates were 85.7% and 91.4%, respectively. The ICI-SF and W-IPSS questionnaires showed a statistical significant improvement in symptom scores.

Conclusions

In the short-term follow-up, the Ajust™ system was effective in restoring continence in more than 85% of subjects with a highly significant improvement in QoL.

Moore RD, Serels SR, Davila GW, Settle P (2009) Minimally invasive treatment for female stress urinary incontinence (SUI): a review including TVT, TOT, and mini sling. Surg Technol Int 18:157–173PubMed

De Ridder D, Berkers J, Deprest J, Verguts J, Ost D, Hamid D, Van der Aa F (2010) Single incision mini-sling versus transobturator sling: a compatrative study on MiniArc and Monarc slings. Int Urogynecol J 21:773–778CrossRef

Preclinical study: a rabbit model to evaluate Ajust™ adjustable single incision sling components-12 weeks data. 2009 C.R. Bard, Inc, http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092607.pdf

Tubaro A, Zattoni F, Prezioso D, Scarpa RM, Pesce F, Rizzi CA et al (2006) Italian validation of the International Consultation on Incontinence Questionnaires. BJU Int 97:101–108CrossRefPubMed

Yalcin I, Bump R (2003) Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 189:98–101CrossRefPubMed

Tubaro A, Prezioso D, Zattoni F, Artibani W, Pesce F, Scarpa RM, Simoni L [2003] The flow study: validation of four questionnaires on symptoms and quality of life in Italian women with LUTS. In: Proceedings of the International Continence Society, 33rd Annual Meeting, Florence, Italy, 5–9 October 2003

Breivik EK, Bjornsson G, Skovlund E (2000) A comparison of pain rating scales by sampling from clinical trial data. Clin J Pain 16:22–28CrossRefPubMed

Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J et al (2010) An International Urogynecological Association (IUGA)/International Continence Society joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J 21:5–26CrossRef

Novara G, Galfano A, Boscolo-Berto R, Secco S, Cavalleri S, Ficarra V, Artibani W (2008) Complication rates of tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials comparing tension-free midurethral tapes to other surgical procedures and different devices. Eur Urol 53:288–309CrossRefPubMed

10.

Boyles S, Edwards R, Gregory W, Clark A (2007) Complications associated with trans-obturator sling procedures. Int Urogynecol J 18:19–22CrossRef

11.

Neuman M (2008) Perioperative complications and early follow-up with 100 TVT- secur procedures. J Minim Invasive Gynecol 15:480–484CrossRefPubMed

12.

Rezapour M, Novara G, Meier PA, Holste J, Landgrebe S, Artibani W (2007) A 3-month preclinical trial to assess the performance of a new TVT-like mesh (TVTx) in a sheep model. Int Urogynecol J 18:183–187CrossRef

13.

Meschia M, Barbacini P, Ambrogi V, Pifarotti P, Ricci L, Spreafico L (2009) TVT secur: a minimally invasive procedure for the treatment of primary stress urinary incontinence. One year data from a multicentre prospective trial. Int Urogynecol J 20:313–317CrossRef

14.

Basu M, Duckett J (2010) A randomised trial of retropubic tension-free vaginal tape versus a mini-sling for stress incontinence. BJOG 117:730–735CrossRefPubMed

15.

Schraffordt Koops SE, Bisseling TM, vanBrummen HJ, Heintz PM, Vervest HAM (2006) What determines a successful tension-free vaginal tape? A prospective multicenter cohort study: results from the Netherlands TVT database. Am J Obstet Gynecol 194:65–74CrossRef

16.

Lim YN, Dwyer P, Muller R, Rosamilla A, Lee J, Kobi S (2010) Do the Advantage slings work as well as the tension-free vaginal tapes? Int Urogynecol J. doi:10.1007/s00192-010-1157-6

17.

Nilsson CG, Palva K, Rezapour M, Falconer C (2008) Eleven years follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J 19:1043–1047CrossRef

18.

Ulmsten U, Falconer C, Johnson P, Jomaa M, Lanner L, Nilsson CG et al (1998) A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J 9:210–213CrossRef

19.

Waltregny D, de Leval J (2009) The TVT-obturator surgical procedure for the treatment of female stress urinary incontinence: a clinical update. Int Urogynecol J 20:337–348CrossRef

Title: Short-term outcomes with the Ajust™ system: a new single incision sling for the treatment of stress urinary incontinence
Authors: Michele Meschia
Pietro Barbacini
Roberto Baccichet
Arturo Buonaguidi
Marco Maffiolini
Luisa Ricci
Chiara Braghin
Valentina Brusati
Chiara Dell’Utri
Lorenzo Spreafico
Publication date: 01-02-2011
Publisher: Springer-Verlag
Published in: International Urogynecology Journal / Issue 2/2011
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-010-1254-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Short-term outcomes with the Ajust™ system: a new single incision sling for the treatment of stress urinary incontinence

Abstract

Introduction and hypothesis

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction and hypothesis

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 2/2011

A fetal scalp electrode as a simple aid in the search for a lost needle fragment during sacrospinous ligament fixation

Delayed presentation of complete ureteral obstruction deligated transvaginally

The original versus a modified inside-out transobturator procedure: 1-year results of a prospective randomized trial

Impact of overactive bladder and lower urinary tract symptoms on sexual health in Japanese women

Is a dipstick test sufficient to exclude urinary tract infection in women with overactive bladder?

Prospective study of anterior transobturator mesh kit (Prolift™) for the management of recurrent anterior vaginal wall prolapse