Relevant, meaningful, and achievable data points are critical in objectively assessing quality, utility and outcomes in female stress urinary incontinence (SUI) surgery. Adherence to the previously proposed minimum data set for future studies in female SUI surgery, outlined in the first AUA Guidelines on the Surgical Management of Female SUI in 1997, has been suboptimal. The SUFU SUI Publication Outcomes Working Group (SSPOWG) was tasked with creating a common minimum data set to be utilized by authors, investigators, journal editors, and reviewers in refereeing literature pertaining to SUI surgery.

The purpose is to create a minimum standard data set for interventional SUI studies and publications in 4 critical areas, including study design, preoperative data, intraoperative events and postoperative outcomes. In addition, the SSPOWG work group was tasked with assigning data points as necessary (STANDARD) for a female SUI intervention study, or as data that can be omitted (ADDITIONAL/OPTIMAL)

The SSPOWG reviewed the minimum data set proposed in the 1997 AUA SUI Guideline document and other relevant literature. The body of literature was examined in the context of the profound changes in the field over the past 25 years. Through an iterative Delphi process, including SUFU, AUGS, and ICS members, a minimum data set was generated, balancing the desire to have a number of meaningful and relevant data points against the burden of creating an excessively difficult or restrictive standard that would disincentivize widespread adoption.

The minimum data set is subdivided into three categories: 1. study features/design; 2. preoperative evaluation; 3. postoperative evaluation. Important study features include an accounting of all patients entered into the study and defined criteria for success. Preoperative evaluation should consist of relevant demographic, anatomical, and physiological characterization of the population under study and patient-reported data in the form of a standardized questionnaire. Postoperative evaluation should include follow up data for all patients at a minimum of one year, at least one residual urine assessment and physical examination, a thorough accounting of intraoperative and postoperative complications/adverse events, outcomes related to the pre-defined criteria for success/failure, and a postoperative patient reported outcomes assessment measured with standardized questionnaire(s).

The proposed structured framework will allow future surgical interventions for female SUI to be objectively scrutinized and compared in a clinically significant manner.

A reasonable, achievable, and clinically meaningful minimum data set has been constructed.  Ultimately, such a data set, if adopted by the academic community, will improve the quality of the female SUI surgical literature.

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 Sep;158(3 Pt 1):875-80.
Bauer A., Zheng Y., Furlong, D. and Rovner, ES,: Adherence to the Minimum Data Set Suggested by AUA Guidelines for the Surgical Treatment of SUI: Urology (in press) 2023
Rovner, ES, Wright, C., Messer, H: Adherence to the 1997 American Urological Association guidelines for the surgical treatment of stress urinary incontinence, Urology 71(2):239-42)  2008

Continence 7S1 (2023) 100724
DOI: 10.1016/j.cont.2023.100724