For decades, the initial published reports of many SUI procedures were optimistic with respect to short-term successful outcomes and low complications. However, with time many of these surgical procedures were abandoned due to long-term failure or complications or both. Upon reflection, the literature in this field had many problems including poor study design (retrospective, etc.) lack of rigorous standardized definitions regarding outcomes (success, failure, etc.), and incomplete reporting of complications and adverse events in the short and long term. Over the ensuing two decades there were some improvements in the literature but it remained short of optimal.
A consensus document was created from a novel collaboration between members of SUFU (Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction), AUGS (American Urogynecologic Society), and ICS (International Continence Society) which provides clear guidance for the structure of clinical studies and reporting of results in the peer-reviewed literature. A minimum data set (MDS) was created including aspects of study design (statistical plan, inclusion/exclusion criteria, success/failure definitions, accounting of all patients, etc.), preoperative elements (demographics, PVR, relevant physical examination findings, questionnaires, etc.), intraoperative elements (complications, concomitant surgeries, clear description of the procedure, etc.) and postoperative elements (complete accounting of complications, immediate and at one year, success/failure using the predetermined definition, administration of the same questionnaire as preoperatively, etc.).
If widely adopted, this MDS has substantial potential ramifications for scientific journals, journal editors, peer reviewers, investigators, regulatory agencies, industry, clinicians, and most importantly, patients.
Written by: Eric S. Rovner, MD, Professor of Urology, Spaulding-Paolozzi Endowed Chair in Female Pelvic Medicine and Reconstructive Surgery, Department of Urology, Medical University of South Carolina, Charleston, SC
Reference:
- Leach GE, Dmochowski RR, Appell RA, Blaivas JG, Hadley HR, Luber KM, Mostwin JL, O'Donnell PD, Roehrborn CG. Female Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence. The American Urological Association. J Urol. 1997, 158(3 Pt 1):875-80.