TOMS Clinical papers

Male Stress Urinary IncontinenceMale stress Urinary Incontinence
A 2015 SPRINGER PUBLICATION

Chapter 9 Functional Devices
A review of all male slings shows the TOMS to be superior in many respects to the alternatives – the surgical technique is the least invasive


I-STOP TOMS Trans Obturator Male Sling, a Minimally Invasive Treatment for Post prostatectomy Incontinence: Continence Improvement and Tolerability
This paper (Urology Vol 79 No 2Vol 79 No 2, Feb 2012) by Prof Grise in France reported for TOMS:

► 103 patients in multi-centre study at 1+ year follow-up
► 59.4% completely dry, and 20.3% on one pad.
► Patient satisfaction over 90%
► No retention compared to 12.9% acute retention for the second most popular sling.


An article by the same authors has been accepted for publication showing these results to continue after 2 years

A recent paper from Costa in France shows results for Advance as follows: At 1 year follow-up
► 21% completely dry, and 28.9% improved to 50% of pre-op pad use. At 2 year follow-up results were similar.


The recommended surgical technique for the TOMS is much less invasive than that recommended for the Advance.

OTHER CLINICAL PAPERS

The Journal of Urology April 2011

Prospective multi-centre (30 centres) trial 122 patients at 360 day follow-up 58% dry and 93% improved


European Journal of Renal & Genito – Urinary Disease 2006

A pilot prospective multicentre study of 50 patients with moderate incontinence has been in progress since June 2006
Published in late 2006, results were encouraging.


ICS 2ics abstract toms008
► Poster presentation 14 patients

► Mean folow-up 18 months

► VAS was 2.5 post-operation, 0.9 at 1 month and 0.1 at 1 year

► Mean pad use reduced from 2.4 to 0.9, 50% used no pad.


AUA 2009
Most of the patients improved or continent with one year follow-up


European Urological Reuropean urologicaleview 2009
96 patients – University of Rouen
► “On the VAS, the median pain value the day after surgery was 2, then decreased
significantly to 1.2 at 1 month and remained at 0.4 for all further visits.”
► “Overall, median pad use decreased significantly from two pads per day before surgery to one pad per day for all visits thereafter. At one,three and six months the number of pad free patients was, respectively 60, 51, and 51%. Continence rate of use of no or one pad per day
was respectively, 74, 82, and 86%


International Braz J Urol 2009
► Multicentre trial with TOMS four arm. 50 patients
► “On the VAS, the median pain value the day after surgery was 2 then decreased significantly to 0 at one month and remained similar for all further visits until the end of the study
► “The ICIQ incontinence score (Figure 4) decreased significantly from 15 before the TOMS sling to 8 at one year, and the median score was 9 for all other visits
at follow-up.”


UroToday.com March 2010
Male stress urinary incontinence: The place of alternatives to an artificial urinary sphincter, by Philippe Grise, MD
► More than 50% of patients were completely continent and more than 70% of the patients were improved in their continence and their quality of life.
► TOMS sling is a safe procedure and pain is not an issue.


Urology 76 (Supplement 3A) September 2010
Melanie Crites DO and Gamal Ghoniem MD Cleveland Clinic Florida

Failure rate with TOMS 16.7% compared to 46.3% with BAMS


Presentation at AUA 2011
Philippe Grise et al

122 patients from 30 centres
93% improved at 360 day follow-up