Recommendations of the SUFU/AUGS/ICS Female Stress Urinary Incontinence Surgical Publication Working Group: A Common Standard Minimum Data Set for the Literature

Introduction and Objectives Relevant, meaningful, and achievable data points are critical in objectively assessing quality, utility, and outcomes in female stress urinary incontinence (SUI) surgery. A minimum data set female SUI surgery studies was proposed by the first American Urological Association guidelines on the surgical management of female SUI in 1997, but recommendation adherence has been suboptimal. The Female Stress Urinary Incontinence Surgical Publication Working Group (WG) was created from members of several prominent organizations to formulate a recommended standard of study structure, description, and minimum outcome data set to be utilized in designing and publishing future SUI studies. The goal of this WG was to create a body of evidence better able to assess the outcomes of female SUI surgery. Methods The WG 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 a DELPHI process, a standard study structure and minimum data set were generated. Care was taken to balance the value of several meaningful and relevant data points against the burden of creating an excessively difficult or restrictive standard that would disincentivize widespread adoption and negatively impact manuscript production and acceptance. Results The WG outlined standardization in four major areas: 1) study design, 2) pretreatment demographics and characterization of the study population, 3) intraoperative events, and 4) post-treatment evaluation, and complications. Forty-two items were evaluated and graded as: STANDARD - must be included; ADDITIONAL - may be included for a specific study and is inclusive of the Standard items; OPTIMAL - may be included for a comprehensive study and is inclusive of the Standard and Additional items; UNNECESSARY/LEGACY - not relevant. Conclusions A reasonable, achievable, and clinically meaningful minimum data set has been constructed. A structured framework will allow future surgical interventions for female SUI to be objectively scrutinized and compared in a clinically significant manner. Ultimately, such a data set, if adopted by the academic community, will enhance the quality of the scientific literature, and ultimately improve short and long-term outcomes for female patients undergoing surgery to correct SUI.


I. INTRODUCTION
Currently, no universal agreement or guidelines on the proper conduct and reporting of studies for the surgical treatment of female stress urinary incontinence (SUI) exist.Historically, such studies have been criticized for their inconsistency and lack of scientific rigor, thereby resulting in scientific literature that is flawed.Lack of standardization has resulted in a preponderance of published studies in the peer-reviewed literature which are retrospective case series, with deficiencies such as poorly described or vague definitions of the patient population or surgical success/failure, incomplete reporting of complications, and inadequate follow-up.Such limitations often result in difficulty assessing long-term outcomes of any single procedure, an inability to be able to compare one procedure to another, and challenges combining case series for metanalysis.3][4][5] Poor quality science has ramifications across many areas, including clinical medicine and patient care, medical education, the peer-reviewed literature, regulatory agencies, and industry.
In recognition of the limitations noted above, several prominent societies with an interest in this field created the Female Stress Urinary Incontinence Surgical Publication Working Group (WG).The goal of the WG was to explicitly define the study structure and minimum data set that should be reported for a female SUI surgical study to be sufficient for publication in the peer-reviewed literature.Herein, we report the summary report from this collaboration.

II. MATERIALS AND METHODS
The members of the WG were selected individually by three organizations active in the field: the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), the American Urogynecologic Society (AUGS), and the International Continence Society (ICS), each of which is associated with its own peer-reviewed journal.The members of the WG met in-person and virtually multiple times over the course of a full year.The process of creating the work product was very similar to that utilized elsewhere in creating guidelines for reporting animal research. 6ndividually and collectively, the WG compiled a detailed list of items or features considered important in designing and evaluating a surgical female SUI intervention study.Such a minimum core of items would create an objective platform to evaluate individual surgery outcomes and permit fair, objective, and meaningful comparisons between different interventions published simultaneously or at different times.
The standardization covered four major areas: a) study design, b) pretreatment demographics and characterization of the study population, c) intraoperative events, d) post-treatment evaluation and complications.Within each of these 4 areas, particular features or data points were formally defined and considered either very important or critical to report in the final publication.In contrast, other features or datapoints were considered less important or irrelevant.
Hundreds of items were considered.Eventually, forty-two potential items were selected, reviewed, and evaluated by the WG.Central to the final grading and selection was the idea that most clinicians, researchers, and other stakeholders would agree that each of the selected items are essential components of a well-done, clinically relevant, and scientifically rigorous study.Using a Delphi process, the WG graded items using a tiered recommendation system.The WG factored in transparency and reproducibility in the selection and grading of items whilst recognizing that a minimum set should be comprehensive but not over-burdensome.Each of the items were assessed individually and independently from one another.Items were specifically graded as to their utility and relevance with respect to study design and as a component of a minimum data set for future studies.Items were qualitatively classified as follows: STANDARD -must be included; ADDITIONAL -may be included for a specific study and is inclusive of the Standard items; OPTIMAL -may be included for a comprehensive study and is inclusive of the Standard and Additional items; UNNECESSARY/LEGACYnot relevant.

III. RESULTS
Thirty-three features were categorized as "STAN-DARDS" that should be included in all studies and study related publications.These 33 standards for the minimum data set are classified into 4 areas: a) study design, b) pretreatment demographics and characterization of the study population, c) intraoperative events, d) post-treatment evaluation and complications.A summary of these items is listed in Appendix A, http:// links.lww.com/FPMRS/A526.

a. Study Design Features
The planning and execution of a clinical research study are essential, with implications for the validity and reproducibility of the study.For researchers, it is imperative to transparently report study design features, thereby allowing readers to readily assess the study's quality, validity, and reproducibility.This process includes documenting the study design, protocol, intervention, methods for data collection statistical plan, and analysis, and concisely presenting study findings and conclusions.Well-designed, randomized controlled trials with power-calculations to determine the adequate sample size of each study arm when properly executed, offer level-one evidence, and are widely regarded as the gold standard for study design.However, observational studies may also have value, given they are easier to perform, less costly, and may contribute to research on medical interventions.For example, observational studies are more appropriate for detecting late or rare adverse events.In addition, observational studies provide insight into real-world utilization and outcomes outside the regulated clinical trial environment.
After utilizing the Delphi process, the WG was unanimous in its opinion that a detailed description of the following should be required as a minimum standard for all manuscripts on female SUI surgical interventions: In addition, current level of sexual activity, dyspareunia, history of pelvic pain (especially if currently treated), and history of recurrent urinary tract infections (UTIs) should be documented.Since pelvic pain can be observed after midurethral sling procedures and virtually all other anti-incontinence procedures, it is important to note if pain was present (yes/no) before an anti-incontinence procedure.STANDARD Likewise, voiding dysfunction symptoms need to be elicited ahead of SUI procedures that may impact voiding function and/or result in urinary retention postoperatively.STANDARD Parity may be included for a specific study, but it need not be included in all female SUI surgical studies.ADDITIONAL.While prior history of pelvic irradiation, and neurological history such as multiple sclerosis or back surgery may be relevant in some studies, especially in complex patients, such information could be considered exclusionary diagnoses in some studies and should be mentioned in this context.STANDARD.
3. Physical examination: Objective demonstration of SUI (e.g. using urodynamics or cough stress test with physical examination) and POP quantification.During physical examination, it should be standard to objectively demonstrate the presence of SUI (cough stress test, and when absent obtain confirmation by urodynamic testing).In addition, the presence of associated POP should be noted and staged using the POP quantification system (POP-Q) to assess the severity of any associated POP.The POP-Q system is standardized and is preferred over other prolapse grading systems such as the Bayden-Walker classification.STANDARD Noting the presence and degree of urethral hypermobility can be considered and may be linked to point Aa of the POP-Q.ADDITIONAL 4. Post-void residual urine determination (PVR).An assessment of PVR should be documented preoperatively.
This can be part of the inclusion/exclusion criteria (i.e.patients were excluded with a PVR above a certain volume), but the presence of incomplete bladder emptying preoperatively may have substantial impact on possible voiding dysfunction postoperatively.There are several methods of determining PVR, including via catheterization or ultrasound, and the method should be specified.STANDARD Intraoperative details provide insights into safety measures, complications, and adverse events related to surgery.Details such as the use of cystoscopy or choice of anesthesia, contribute to risk stratification.This information is valuable for identifying factors that may influence the likelihood of complications and tailoring intraoperative procedures accordingly.
Ultimately, SUI outcomes research aims to identify the safest and most effective approaches to SUI surgery.Details related to intraoperative procedures are necessary and help attribute specific outcomes to the surgical procedure.ates may vary depending on factors such as surgeon experience, patient characteristics (e.g.BMI), and the route of sling placement.Intraoperative cystoscopy is a method for detecting urinary tract perforation and avoiding unrecognized perforation during surgery.Notably, there are no published randomized controlled trials comparing patients undergoing cystoscopy versus those not undergoing cystoscopy during sling surgery.Therefore, the Panel considers it a standard to clearly document the use or non-use of intraoperative cystoscopy to provide necessary context for interpreting surgical outcomes. 13,14If cystoscopy was not utilized, this should also be clearly stated.STANDARD 4. Accounting of intraoperative complications (e.g.visceral, vascular injuries, cystotomy, need for transfusion).Intraoperative complications should be reported consistently for comparison across studies.For example, while many surgeons do not consider bladder perforation as a complication in trocar-based MUS, the long-term impact is unknown and thus trocar perforation should be reported along with other adverse events that change surgical management. 15Other intraoperative complications or adverse events possibly related to anti-incontinence procedure should be included, such as visceral, vascular, and genitourinary injuries along with blood transfusions.STANDARD 5. Type of anesthesia (local, regional, general, office vs.OR, e.g.) Currently, transurethral bulking agent procedures are commonly performed in clinic settings for SUI surgery.While it would be beneficial to include information related to procedures performed under local or office setting, the WG recommends that the type of anesthesia for the procedure be classified as additional information.ADDITIONAL

d. Postoperative Outcomes/Features
To fully evaluate surgical outcomes for female SUI, appropriate follow-up and evaluation are required.Longer post-operative follow-up is always welcomed; however, it is also imperative that all patients included in a study have a minimum degree of follow-up as well.
For example, it would be inappropriate to report a cohort study with an average follow-up of five years but have some patients included in the study with a followup of just a few months.The WG agreed that the postoperative evaluation should mirror the preoperative evaluation, when appropriate.In addition, to fully understand surgical outcomes it is important that any need for re-intervention, whether it be for recurrent SUI or other indications, be included in any manuscript to optimally understand both the outcomes and safety of the treatment for SUI that is being evaluated.To clearly assess the effect and robustness of the treatment, it is necessary to have a follow-up period that is long enough to appreciate the efficacy and the possible waning of the treatment effect with time as well as adverse events such as voiding dysfunction, mesh exposures and pain.The WG agreed that repeat evaluations (e.g., evaluation at 3-and 12-months post-surgery) are preferred to adequately follow trends after intervention.As such, studies evaluating outcomes related to surgical therapies for female SUI should have a mean/median minimum follow-up of at least 12 months for ALL patients.Moreover, after 6 months, late healing abnormalities like mesh sling contraction may occur. 16A 12-month mean/median follow-up is considered crucial.STANDARD A mean/median follow-up of 48 months or more for all patients would be considered an optimal length of follow-up post-intervention for female SUI.OPTIMAL 3. Elimination of the terms "short" "medium" and "long-term" follow-up.These terms are subjective and multi-interpretable and should, therefore, be avoided.A precise time frame from surgical intervention should be stated.STANDARD 4. Physical examination performance postoperatively.
The WG agrees that a postoperative physical examination is essential for all patients who underwent surgical intervention for female SUI.Components of the physical examination include evaluation of the surgical location for tenderness, evaluation of the surgical site for smoothness and lack of mesh exposure (if applicable), presence and degree of urethral hypermobility (especially if part of the pre-treatment evaluation), and a post-treatment cough stress test.The chosen test position (e.g., supine, standing) and technique should be the same method as was done as part of the pretreatment assessment.STANDARD 5. PVR (mean/median/range with definition of "abnormal" PVR).The WG determined that it is important to assess the degree of de novo voiding dysfunction by measuring postoperative post-void residual (PVR) to assess the effect of the SUI treatment on post-treatment voiding.This should be done using the same preoperative method.Although the exact definition of an abnormal or elevated PVR remains controversial, the study should define this parameter in the study protocol and report with reference to their definitions of an elevated PVR and urinary retention.STANDARD 6. Reporting of success/failure/improved: Objective/ Subjective.As stated in the Preoperative Data section, the subjective and/or objective definitions of and diagnosis of SUI should be defined pre-treatment.The same pretreatment definition used to identify and diagnose SUI should be used post-intervention to evaluate for subjective and/or objective outcomes.In addition, the outcomes from the tools used to measure post-treatment success/failure/ improvement, should be identified prior to study initiation, and described in the Methods section.There are a variety of methods used to evaluate for SUI pre-and posttreatment (e.g., symptoms, questionnaires, examination, urodynamics); however, the WG did not identify a preferred method as that was left to the discretion of the investigators.STANDARD While the WG concluded that reporting surgical success/ improvement/failure is a STANDARD, reporting the degree of SUI severity for failures is not a requirement but is considered ADDITIONAL information.There are a variety of methods that would allow for pre-and post-treatment reporting of SUI severity (e.g., questionnaire, bladder dairy, urodynamics).The WG did not identify a preferred method to evaluate this outcome; however, if the authors do intend to report SUI severity for failures, then that method should be defined prior to study initiation and described in the Methods section.ADDITIONAL 7. Questionnaire results.As stated in the Preoperative Data section, baseline questionnaires are regarded as a STAN-DARD.The WG did not specify a "preferred" questionnaire nor did the WG specify what type of questionnaire (s) (e.g., quality of life [QOL], symptom-based) should be administered.Yet, there was agreement among the WG that the questionnaires should be easy to score, translated in several languages, and validated to be performed both in person and remotely.Furthermore, the same questionnaire(s) administered pre-treatment should also be administered post-treatment.The WG also noted the importance of patient-centered outcome measures.While not a requirement, authors could also consider using an additional questionnaire post-treatment that evaluates for improvement and/or satisfaction after intervention, such as the Patient Global Impression of Improvement (PGI)-I.STANDARD 8. Complications reporting/accounting at six months.
As the minimum follow-up for all patients in a female SUI surgical study is six months post-treatment, all patients should have an accounting of adverse outcomes during this minimum follow-up period.The reporting of adverse outcomes/complications should be categorized with the time period that the events occurred.For example, within six week or between 6 weeks an 12 months.The categories of possible adverse outcomes/complications are included in Table 1.STANDARD 9. Reoperation rate for persistent/recurrent SUI.The WG agreed that any assessment of surgical efficacy include reintervention and/or reoperation for persistent or recurrent SUI following the index SUI procedure.As such, the inclusion of reoperation rates for all causes is considered a STANDARD for all manuscripts of studies for the n AUGS-SUFU-ICS JOINT PUBLICATION surgical treatment of female SUI.To reassure the reader of how this critical information was sought and obtained, the manuscript should be explicit in their assessments of reoperation/retreatments for SUI.It must be explicit to the reader how this information was obtained.For example, were chart reviews, payor data, and/or direct patient responses used?Furthermore, the authors should assess and include whether reoperation/reintervention data on surgical treatment for persistent SUI was missed because of patients lost to follow-up, non-response to treatment, and/or patient relocation during the study period.In addition, the full list of types of reoperations and reinterventions to treat persistent or recurrent SUI should be included in the manuscript.Referral to pelvic floor physical therapy (PFPT) and the use of vaginal inserts or pessaries when employed for the treatment of post-procedure persistent or recurrent SUI should also be considered reinterventions, and these treatments should be included in the manuscript.Regardless of continence status at the conclusion of the study period, patients requiring reintervention or reoperation for any degree of persistent SUI should be categorized and analyzed as treatment failures for the index procedure.STANDARD An example of a manuscript that follows these recommendations is seen with the Urinary Incontinence Treatment Network studies. 17The authors performed a secondary analysis of the SISTER trial (Burch vs Autologous Fascial Sling) and the TOMUS trial (retropubic [RP] vs transobturator [TOT] midurethral [MUS]) to assess reoperation rates for recurrent SUI at 5 years following their index SUI procedure.Outcome measures included surgical and non-surgical retreatments for recurrent SUI, the number of surgical retreatments, types of first and/or second retreatments, and the time between study surgery and first retreatment.In this manuscript, the authors clearly listed all retreatments by study surgery, including all surgical treatments and all non-surgical treatments (pharmacologic, pelvic floor physiotherapy and vaginal inserts or pessaries).

IV. DISCUSSION
Over the last few decades, the surgical landscape for the treatment of female SUI has significantly evolved.Various surgical treatments have fallen out of favor, and newer methods have risen to the forefront.In the 1990s, a shift occurred, with the rapid increase in midurethral sling procedures and a decrease in the use of the many other anti-incontinence procedures.A trend toward minimally invasive approaches has been observed, even more so with some newer technologies.Controversies, regulatory warnings, and negative media coverage have raised physician and patient awareness concerning the importance and need for scientifically rigorous clinical trials to help assess and compare efficacy and safety despite the trends and popularity of various procedures.These trials must also provide some estimation of ultimate durability of the interventions and any attendant risks which may become only apparent with follow up that is longer than noted with historic studies.Additionally, common outcomes definitions and reporting are critical for comparing subject populations and technologic / procedural variants.Acknowledging the inherent weaknesses and the perceived lack of quality in the SUI literature at the time, the 1997 AUA Female SUI Guideline Panel document recommended and outlined a minimum patient data set (MDS) to be used in future interventional SUI studies by investigators for purposes of potentially reporting uniform outcomes in the peer-reviewed literature. 1 Subsequent studies demonstrated poor adherence to the proposed MDS.  4 The pervasive poor adherence of contemporary research studies to the proposed MDS can be attributed to several potential causes: overly burdensome, too difficult to implement in the typical clinical setting, too vague in reporting requirements, and lack of relevance, all of which contribute to unnecessary research burden.
So as to not inhibit innovation and to allow the evolution of available and new procedures, the WG was formed to ensure that surgical interventions for female SUI are evaluated rigorously with regards to study design and metrics, whilst allowing direct comparison between different interventions.This is especially important for a condition like SUI, which affects quality of life.A reasonable, achievable, and clinically meaningful MDS would help improve the quality of the literature to help attenuate the subjective limitations of the review process for authors, peer-reviewers, and journal editors.Such a structured framework will allow future surgical interventions for female SUI to be objectively scrutinized and compared in a clinically significant manner.Ultimately, such an MDS, if adopted by the academic community, will improve the quality of the female SUI surgical literature.
One of the first objectives of this WG was to focus on the identification of important data items and outcomes whilst reducing the burden of data entry.As such we sought to identify key items that should be consistently reported in all surgical female SUI studies.To be included in our MDS, items had to be accurate (measurable), objective, uniform and have important implications for clinical decision making.
The measurement and comparison of surgical procedures performance is necessary, and it is a requisite for patients (first and foremost), clinicians, medical regulatory authorities, and hospital administrators.While RCTs represent the gold standard for comparing two interventions, they are cumbersome, expensive, and not always practically feasible.Realistically, most of the surgical female SUI studies are non-RCTs.Our proposed MDS is intended to serve as a resource to maximize comparable reporting across studies and to contribute to evidence-based practice research and real-world effectiveness/cost-effectiveness research.
As practice changes over time, these recommendations should evolve to remain clinically relevant and reflect current practice.For instance, over the last decade, the use of urodynamics in patients has become controversial, especially its utility in the preoperative evaluation of the uncomplicated female with SUI, based on a multi-center randomized study showing non-superiority of urodynamics to office-based evaluation. 18Also, reflecting the dynamic and evolving landscape of the SUI literature, patient-reported outcomes (PROs) that are robust and validated are now universally accepted and deemed necessary to adequately assess, compare and understand patient-reported experiences and outcomes.
Considerable thought was put into the list put forth by the WG.Whilst it was developed using a Delphi process, the authors accept that it represents a minimum list and may not be perfect.The authors are hoping similar recommendations for MDS for other urinary incontinence interventions and other urological areas of study may be formulated and implemented.
The authors recognize that there may be challenges to the implementation of this recommended minimal data set, but we believe that the proposed framework is feasible, reasonable, and consistent with what is expected from stakeholders, surgeons, and patients.The authors believe the AUA, ICS, SUFU, and the AUGS should commit to a leadership role in helping implement this MDS in future studies, thereby driving improvement in management individually and collectively.
As the future landscape of surgical female SUI evolves with new approaches, developing technologies, and further research, these reporting criteria will be regularly updated and revised based on the science and practice.This should support continued alignment within the literature and facilitate (i.e., not impede) technological and academic progress.

V. CONCLUSION
A standardized approach to the study of female SUI surgery studies is presented.This document provides a framework for interested clinicians, researchers, regulatory agencies, industry, and journal peer reviewers and editors to objectively evaluate the design, n AUGS-SUFU-ICS JOINT PUBLICATION conduct and reporting of female SUI surgery studies.An outline of the essential components of a well-done study are described with respect to being clinically relevant, scientifically rigorous, transparent, and reproducible without being overburdensome.This paradigm can be referenced as a "checklist" by investigators, authors, peer reviewers, and journal editors (see Appendix A, http://links.lww.com/FPMRS/A526).Adherence to these elements provide a means to evaluate future interventions across the variables of time, location, and surgical bias.In addition, this document should allow accurate comparisons between procedures, especially with regards to metanalysis and guideline documents.It is important to note that these recommendations may be modified in the future as interventions, evaluative tools and metrics change, and the philosophy of SUI treatment and outcomes evolve.
If widely adopted across the relevant stakeholders, the guidance provided by this document will positively impact the quality of the SUI surgical literature and improve patient care.
Finally, the principles described herein should not be limited to the study of female SUI surgery but may be applied to other areas across the surgical spectrum.With some modifications, these principles may be applicable to non-surgical therapies as well.
critical element of any SUI study is to provide precise pretreatment demographic information and a thorough characterization of the study population, including patient history, examination findings, post-void residual, and validated questionnaires.In the pretreatment evaluation, demographic information that should be documented includes age, BMI, and race/ ethnicity.These 3 demographic domains have been shown to relate to SUI surgical outcomes in many studies and are easily accessible in charts or electronic records.STANDARD 2. History: Prior SUI/POP interventions, quantitation of detrusor dysfunction/OAB symptoms, dyspareunia/ sexual function, pelvic pain, and recurrent UTIs.
6. Discussion of statistical plan/analysis.The authors must describe the pre-specified statistical plan and analysis, including the statistical method utilized for group comparison, subgroup analysis, and any adjusted analyses.When applicable, methods used for sample size determination, randomization, participant selection, and blinding should be reported.STANDARD b.Preoperative Data/Features A 1. Demographics: Age, body mass index (BMI) and race/ ethnicity.Prior SUI or POP interventions (to help differentiate treatment naïve SUI cases from re-operated SUI cases) as well as any prior use of mesh (including a review of operative note when available), the material used, and the location of mesh placement (urethra, and/or vaginal wall compartment(s)) should be documented.STANDARD Other elements of importance from the history include information on symptoms associated with bladder overactivity (mixed urinary incontinence/MUI) and/or voiding dysfunction.
By documenting these details, researchers can compare the efficacy of different interventions and identify factors contributing to successful outcomes.Clear documentation of intraoperative procedures also enhances the reproducibility of studies.
10een stress, mixed, and urge incontinence.Given these factors, it was deemed to have little value in the context of SUI studies.UNNECESSARY 6. Questionnaires.Many patient-reported outcomes (PRO) can be obtained by validated questionnaires to gauge SUI symptom severity as well as the impact of SUI on quality of life (Qol).The distinction between SUI and UUI can be challenging to discriminate in some women with mixed urinary incontinence (MUI).One example includes the MESA9was endorsed by the Urinary Incontinence Treatment Network (UITN) as it had been validated and can quantify each component.Other validated questionnaires can be selected by the authors and must be referenced.Regarding SUI-related questionnaires, the WG suggested a set of simple criteria for selecting an appropriate questionnaire comparable across studies.Such a PRO questionnaire should be easy to administer (i.e.relatively short, like some short forms of larger questionnaires) to ensure patient adherence, simple to score, translated in several languages, and tested for administration over the phone10and in telemedicine.Significant work has been done on this topic c.Intraoperative Data/Events Intraoperative details are vital in SUI outcomes research.Variations in intraoperative procedures can influence the safety and effectiveness of SUI treatments.nAUGS-SUFU-ICS JOINT PUBLICATION Use or non-use of cystoscopy.While the risk of bladder perforation during sling surgery is generally low (0.6-4.5%), 1. Full description of intervention.The intervention (surgical procedure) should be properly and unambiguously characterized in the manuscript with a description of the procedure(s) performed to treat the SUI (i.e., synthetic midurethral sling, autologous rectus sling, retropubic urethropexy, or transurethral bulking agent/injection).It can be appropriate to refer to the protocol or prior technique paper if available in the supplemental materials or previous publication.STANDARD 2. Quantitation of concomitant surgery.Pelvic organ prolapse (POP) is frequently associated with SUI.Concomitant POP repair and the associated materials used may impact SUI outcomes.When concomitant procedures are performed, they should be characterized and accounted for in the study report.The description of other concomitant pelvic surgical procedures (e.g.hysterectomy, urethral diverticulectomy) should also be included.If no additional procedures were performed in addition to the SUI surgery in the study population, it should be stated as such.STANDARD 3.

TABLE 1 .
Complications and Adverse Events ■ Pain (chronic, persistent, de novo, neuropathic, location) • Relatedness/plausibility to surgery ■ Fistula ■ Vascular injury/bleeding ■ Visceral injury ■ Other 2-4 Rovner et al. demonstrated low compliance among articles published in two specific journals in the years immediately following the release of the proposed MDS, with approximately 75% adherence reported. 2Subsequently, Tuong et al. examined only articles published in Journal of Urology, Urology and Neurourology and Urodynamics in 2017, with a mean overall compliance at 52%. 3 More recently, Bauer et al. reiterated the observed suboptimal adherence with an average compliance score of 62% for 380 articles published from 2005-2016 over a wide variety of journals.