Urinary Incontinence Research: Compliance With Research Standards for Clinical Studies

Tuong, Mei; Patel, Nickhil; Zillioux, Jacqueline; Rapp, David E.

doi:10.1016/j.urology.2019.11.032

Cited by 5 publications

(6 citation statements)

References 16 publications

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“…Foremost, our study demonstrated significant improvements across a variety of subjective and objective outcomes designed to assess symptoms severity, QOL, and objective muscle strength. The use of these various measures in our study is consistent with longstanding guidelines detailing standards for research related to UI that highlight the importance of both objective and subjective measures as well as QOL assessment (27). Although success rates following PFMT for UI in high income counties (HIC) vary considerably across the literature, the improvements seen in our cohort are consistent with the large body of reported literature to date (18).…”

Section: Discussionsupporting

confidence: 86%

Pelvic floor therapy program for the treatment of female urinary incontinence in Belize: a pilot study

Rapp,

Zillioux,

Sun

et al. 2024

Front. Glob. Womens Health

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IntroductionUrinary incontinence (UI) is highly prevalent in low- and middle-income countries (LMIC). Concurrently, the availability of surgical or conservative UI treatments in LMIC is limited.MethodsWe conducted a prospective feasibility study of Belize women with UI treated with pelvic floor physical therapy (PFPT) and education (PFE). Patients received individual PFPT/PFE over 2 days, consisting of biofeedback-enhanced PFMT in addition to behavioral, dietary, and general pelvic education. Patient completed a daily 6-month home regimen including 7 PFMT exercises (total 70 repetitions) comprising both endurance and quick flick exercises. Patients also performed comprehensive dietary and behavioral modification activities. Outcomes were assessed at baseline and 6-months, including validated symptom (ICIQ-FLUTS) and QOL (IIQ-7) questionnaires, and strength testing (PERFECT score, perineometry).ResultsTwenty-eight patients underwent baseline assessment. Four patients were lost to in-person 6-month follow-up, with two of these patients completing subjective assessment only by telephone. The mean (±SD) patient age, BMI, and parity were 50.0 (±10.0) years, 33.2 (±5.8), and 2.8 (±1.5). Provider assessment demonstrated patient comprehension of basic, endurance, and quick flick pelvic floor contractions in 28 (100%), 24 (86%), and 24 (86%) patients, respectively. At 6-month follow-up, significant improvements were seen across multiple validated questionnaire and strength measurement assessments. Median patient-reported improvement level was 7.0 on a 10-point Likert scale.DiscussionStudy patients demonstrated good understanding of PFMT/PFE and program completion was associated with significant improvements across a variety of subjective incontinence and quality of life outcomes, as well as objective strength testing.

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Section: Discussionsupporting

confidence: 86%

Pelvic floor therapy program for the treatment of female urinary incontinence in Belize: a pilot study

Rapp,

Zillioux,

Sun

et al. 2024

Front. Glob. Womens Health

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“…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.…”

Section: Discussionmentioning

confidence: 99%

“…Subsequent studies demonstrated poor adherence to the proposed MDS 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 2 .…”

Section: Discussionmentioning

confidence: 99%

“…1 Unfortunately, several subsequent studies have noted poor adherence to these recommendations. [2][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.…”

Section: Introductionmentioning

confidence: 99%

“…The first American Urological Association (AUA) guidelines document, the 1997 Female Stress Urinary Incontinence Clinical Guidelines Panel, acknowledged these weaknesses and proposed standardized study parameters and outcome measures based on recommendations from the Urodynamics Society for future studies in the field 1 . Unfortunately, several subsequent studies have noted poor adherence to these recommendations 2–5 . Poor quality science has ramifications across many areas, including clinical medicine and patient care, medical education, the peer-reviewed literature, regulatory agencies, and industry.…”

Section: Introductionmentioning

confidence: 99%

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

Rovner,

Chermansky,

Costantini

et al. 2024

UROGC

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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.

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Recommendations of the SUFU/AUGS/ICS Female Stress Urinary Incontinence Surgical Publication Working Group: A common standard minimum data set for the literature

Rovner,

Chermansky,

Costantini

et al. 2024

Neurourology and Urodynamics

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Introduction and ObjectivesRelevant, 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.MethodsThe 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.ResultsThe WG outlined standardization in four major areas: (1) study design, (2) pretreatment demographics and characterization of the study population, (3) intraoperative events, and (4) posttreatment 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.ConclusionsA 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.

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Urinary Incontinence Research: Compliance With Research Standards for Clinical Studies

Cited by 5 publications

References 16 publications

Pelvic floor therapy program for the treatment of female urinary incontinence in Belize: a pilot study

Pelvic floor therapy program for the treatment of female urinary incontinence in Belize: a pilot study

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

Recommendations of the SUFU/AUGS/ICS Female Stress Urinary Incontinence Surgical Publication Working Group: A common standard minimum data set for the literature

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