E U R O P E A N U R O L O G Y 5 9 ( 2 0 1 1 ) 9 4 5 – 9 4 7 947

Platinum Priority

doi:10.1016/j.eururo.2011.02.021

Reply from Authors re: Elisabetta Costantini and MassimoLazzeri. Surgery for Stress Urinary Incontinence: So Nearand Yet So Far. Eur Urol 2011;59:945–6

Rui Oliveira a, Francisco Botelho a, Pedro Silva a,Alexandre Resende a, Carlos Silva a, Paulo Dinis a,b,Francisco Cruz a,b,*

a Hospital de Sao Joao, Servico de Urologia, Porto, Portugalb IBMC, Institute of Molecular and Cellular Biology of Porto, Portugal

We cannot agree more with Professors Costantini and

Lazzeri in their editorial [1], as, in our opinion, they touch on

three essential points. First, there is the need to adequately

compare new devices with a gold standard technique to

have sound scientific support ahead of their widespread use

for the treatment of female stress urinary incontinence.

There is no valid reason to have looser rules for the

introduction of slings than for the introduction of new

drugs. Second, rigorous and reproducible methods of

assessing outcomes must be standardized and obligatory

in all published studies, so high-quality evidence can be

adequately drawn. These outcome assessments should

include objective and subjective (patient-reported out-

DOIs of original articles: 10.1016/j.eururo.2011.01.018,10.1016/j.eururo.2011.01.050* Corresponding author. Department of Urology, Hospital de Sao Joao,E.P.E., Alameda Professor Hernani Monteiro, 4200-319 Porto, Portugal.Tel. +351225513654; Fax: +351225513655.E-mail address: cruzfjmr@med.up.pt (F. Cruz).

comes) efficacy evaluations as well as quality-of-life

questionnaires. Third, it should be mandatory to investigate

materials used to ensure that they remain safe, as they will

stay in patients’ bodies for many years, most probably the

remainder of their lives.

Our contribution is modest [2], but we think these phase

2 studies are crucial in defining which of the new devices

should be further compared with standard techniques in

well-powered phase 3 clinical trials. Only at this point, if

scientific evidence is adequate, should the new devices be

available in everyday clinical practice.

Conflicts of interest: The authors have nothing to disclose.

References

[1] Costantini E, Lazzeri M. Surgery for stress urinary incontinence: so

near and yet so far. Eur Urol 2011;59:945–6.

[2] Oliveira R, Botelho F, Silva P, Resende A, Silva C, Dinis P, Cruz F.

Exploratory study assessing efficacy and complications of TVT-O,

TVT-Secur, and Mini-Arc: results at 12-month follow-up. Eur Urol

2011;59:940–4.