Int Urogynecol J (2009) 20:313–317 DOI 10.1007/s00192-008-0772-y
ORIGINAL ARTICLE
TVT-secur: a minimally invasive procedure for the treatment of primary stress urinary incontinence. One year data from a multi-centre prospective trial Michele Meschia & Pietro Barbacini & Virginio Ambrogi & Paola Pifarotti & Luisa Ricci & Lorenzo Spreafico
Received: 15 October 2008 / Accepted: 5 November 2008 / Published online: 27 November 2008 # The International Urogynecological Association 2008
Abstract The objective of this study is to evaluate the efficacy and morbidity of the new minimally invasive TVT-secur procedure. This was a prospective multi-centre trial. All patients with primary urodynamic stress urinary incontinence were prospectively selected to receive the TVT-secur procedure. The International Consultation on Incontinence—Short Form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS), Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Improvement (PGI-I) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on quality of life (QoL) and to measure patient’s perception of incontinence severity and improvement. The SPSS software was used for data analysis. From November 2006 to September 2007, 95 consecutive patients were enrolled in the study. At 1 year, 91 patients were available for the analysis. The subjective and objective cure rates were 78% and 81%, respectively. The ICIQ-SF and W-IPSS symptoms score showed a statistically significant decrease. Post-operative complications included voiding difficulty, recurrent UTI, de M. Meschia (*) : P. Barbacini Department Obstetrics and Gynecology, Ospedale “G. Fornaroli”, Magenta, Italy e-mail:
[email protected] V. Ambrogi Department of Obstetrics and Gynecology, OORR, Anzio–Nettuno, Italy P. Pifarotti Department of Obstetrics and Gynecology, IRCCS Fondazione Policlinico Mangiagalli e Regina Elena, Milan, Italy L. Ricci : L. Spreafico Department Obstetrics and Gynecology, Ospedale di Montecchio Emilia, Italy
novo urgency incontinence and dyspareunia. Our data show that TVT-secur is associated with an 80% success rate at 1 year. Keywords Complications . New surgery . QoL . Stress urinary incontinence . TVT-secur Abbreviations SUI stress urinary incontinence QoL quality of life MUCP maximum urethral closure pressure
Introduction The TVT-secur system is a new, minimally invasive sling procedure for the treatment of female stress urinary incontinence (SUI). The device consist of a short 8× 1.1-cm prolene laser cut tape, the same material of the standard TVT, which is coated on both ends with an absorbable fleece material (Ethisorb). The absorbable material is made of Vicryl and PDS (Polyglactin 910 and Poly-P-Dioxanon) and it has been shown to provide strong fixation force into tissues with pull-out force as high as the initial fixation force of standard TVT [1]. This material is usually absorbable within 90 days with prolene remaining intact to provide long-term fixation. A curved stainless steel inserter instrument and “release wire” is attached on both ends to the mesh. The prosthetic implant is placed under the mid-urethra and can be fixed in the “hammock” position into the obturator internus muscle or in the “U”-shaped position into the connective tissue of the urogenital diaphragm behind the pubic bone (Fig. 1).
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Int Urogynecol J (2009) 20:313–317
“Hammock” position
“U” position Fig. 1 The device can be placed both in a “hammock” or “U” position
The aim of the present study was to evaluate the efficacy and morbidity of the new minimally invasive TVT-secur procedure in the treatment of primary SUI.
Materials and methods The study design was a prospective multi-centre trial involving four different hospitals. All patients with primary urodynamic SUI and urethral hypermobility were prospectively selected to receive the TVT-secur procedure. Each centre was allowed to perform the procedure either in the “hammock”- or “U”-shaped approach. Exclusion criteria from the study were: previous anti-incontinence surgery, pelvic organ prolapse requiring treatment, any coexistent pelvic pathology, urethral hypomobility (ΔQ-tip
