RISE FOR HEALTH: Rationale and protocol for a prospective cohort study of bladder health in women

For the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium

doi:10.1002/nau.25074

RISE FOR HEALTH: Rationale and protocol for a prospective cohort study of bladder health in women

For the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium

Research output: Contribution to journal › Article › peer-review

26 Scopus citations

Abstract

Introduction: The spectrum of bladder health and the factors that promote bladder health and prevent lower urinary tract symptoms (LUTS) among women are not well understood. This manuscript describes the rationale, aims, study design, sampling strategy, and data collection for the RISE FOR HEALTH (RISE) study, a novel study of bladder health in women conducted by the Prevention of Lower Urinary Tract Symptom (PLUS) Research Consortium. Methods and Results: RISE is a population-based, multicenter, prospective longitudinal cohort study of community-dwelling, English- and Spanish-speaking adult women based in the United States. Its goal is to inform the distribution of bladder health and the individual factors (biologic, behavioral, and psychosocial) and multilevel factors (interpersonal, institutional, community, and societal) that promote bladder health and/or prevent LUTS in women across the life course. Key study development activities included the: (1) development of a conceptual framework and philosophy to guide subsequent activities, (2) creation of a study design and sampling strategy, prioritizing diversity, equity, and inclusion, and (3) selection and development of data collection components. Community members and cross-cultural experts shaped and ensured the appropriateness of all study procedures and materials. RISE participants will be selected by simple random sampling of individuals identified by a marketing database who reside in the 50 counties surrounding nine PLUS clinical research centers. Participants will complete self-administered surveys at baseline (mailed paper or electronic) to capture bladder health and LUTS, knowledge about bladder health, and factors hypothesized to promote bladder health and prevent LUTS. A subset of participants will complete an in-person assessment to augment data with objective measures including urogenital microbiome specimens. Initial longitudinal follow-up is planned at 1 year. Discussion: Findings from RISE will begin to build the necessary evidence base to support much-needed, new bladder health promotion and LUTS prevention interventions in women.

Original language	English (US)
Pages (from-to)	998-1010
Number of pages	13
Journal	Neurourology and Urodynamics
Volume	42
Issue number	5
DOIs	https://doi.org/10.1002/nau.25074
State	Published - Jun 2023

Bibliographical note

Funding Information:
We gratefully acknowledge the collegial research work of the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium members, listed below. We also acknowledge the artistic talent of the late Michele (Shelli) Quackenboss and her contribution to the RISE FOR HEALTH participant‐facing materials. For this study was provided through the following NIH awards: This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH) by cooperative agreements [U24 DK106786, U01 DK106853, U01 DK126045, U01 DK106858, U01 DK106898, U01 DK106893, U01 DK106827, U01 DK106908, U01 DK106892]. The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Funding Information:
Linda Brubaker: Editorial stipends from JAMA, Female Pelvic Medicine and Reconstructive Surgery and Up to Date. Jamie W. Griffith—Remuneration for speaking engagements and research consulting. Research funding from Pfizer, the National Eczema Association, and Northwestern University. Kim Kenton: Research support Axonics, Expert witness Butler Snow/Ethicon. Emily S. Lukacz—Axonics: Consultant; Boston Scientific: Research funding; Cogentix/Uroplasty: Research funding; Pathnostics: Consulting/Scientific Advisory Board; Urovant: Scientific Advisory Board; UpToDate: Royalties. Elizabeth R. Mueller: UpToDate: Royalties. Diane K. Newman—Research funding: Society of Urology Nurses & Associates; Patient Survey Research: Holliste; Consulting/Scientific Advisory Board; Convatec, Coloplast, COSM, EBT Medical, Urovant Sciences; Editorial: Digital Science Press. Leslie M. Rickey: UpToDate: Royalties; UroCure LLC: Quality and Safety Oversight Committee; Renovia Inc: Advisory Board. The remaining authors have no conflict of interest.

Publisher Copyright:
© 2022 Wiley Periodicals LLC.

Keywords

bladder health
epidemiology
health promotion
longitudinal study
lower urinary tract symptoms
social ecological framework
women's health

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10.1002/nau.25074

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@article{49c4b211c7e848c7b1bc54fc2119154f,

title = "RISE FOR HEALTH: Rationale and protocol for a prospective cohort study of bladder health in women",

abstract = "Introduction: The spectrum of bladder health and the factors that promote bladder health and prevent lower urinary tract symptoms (LUTS) among women are not well understood. This manuscript describes the rationale, aims, study design, sampling strategy, and data collection for the RISE FOR HEALTH (RISE) study, a novel study of bladder health in women conducted by the Prevention of Lower Urinary Tract Symptom (PLUS) Research Consortium. Methods and Results: RISE is a population-based, multicenter, prospective longitudinal cohort study of community-dwelling, English- and Spanish-speaking adult women based in the United States. Its goal is to inform the distribution of bladder health and the individual factors (biologic, behavioral, and psychosocial) and multilevel factors (interpersonal, institutional, community, and societal) that promote bladder health and/or prevent LUTS in women across the life course. Key study development activities included the: (1) development of a conceptual framework and philosophy to guide subsequent activities, (2) creation of a study design and sampling strategy, prioritizing diversity, equity, and inclusion, and (3) selection and development of data collection components. Community members and cross-cultural experts shaped and ensured the appropriateness of all study procedures and materials. RISE participants will be selected by simple random sampling of individuals identified by a marketing database who reside in the 50 counties surrounding nine PLUS clinical research centers. Participants will complete self-administered surveys at baseline (mailed paper or electronic) to capture bladder health and LUTS, knowledge about bladder health, and factors hypothesized to promote bladder health and prevent LUTS. A subset of participants will complete an in-person assessment to augment data with objective measures including urogenital microbiome specimens. Initial longitudinal follow-up is planned at 1 year. Discussion: Findings from RISE will begin to build the necessary evidence base to support much-needed, new bladder health promotion and LUTS prevention interventions in women.",

keywords = "bladder health, epidemiology, health promotion, longitudinal study, lower urinary tract symptoms, social ecological framework, women's health",

author = "\{For the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium\} and Smith, \{Ariana L.\} and Kyle Rudser and Harlow, \{Bernard L\} and Gerald McGwin and Julia Barthold and Brady, \{Sonya S\} and Linda Brubaker and Cunningham, \{Shayna D.\} and Griffith, \{James W.\} and Kim Kenton and Heather Klusaritz and Lewis, \{Cora E.\} and Lukacz, \{Emily S.\} and Julia Maki and Markland, \{Alayne D.\} and Mueller, \{Elizabeth R.\} and Newman, \{Diane K.\} and Jesse Nodora and Rickey, \{Leslie M.\} and Todd Rockwood and Melissa Simon and Wyman, \{Jean F\} and Siobhan Sutcliffe",

note = "Funding Information: We gratefully acknowledge the collegial research work of the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium members, listed below. We also acknowledge the artistic talent of the late Michele (Shelli) Quackenboss and her contribution to the RISE FOR HEALTH participant‐facing materials. For this study was provided through the following NIH awards: This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH) by cooperative agreements [U24 DK106786, U01 DK106853, U01 DK126045, U01 DK106858, U01 DK106898, U01 DK106893, U01 DK106827, U01 DK106908, U01 DK106892]. The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Funding Information: Linda Brubaker: Editorial stipends from JAMA, Female Pelvic Medicine and Reconstructive Surgery and Up to Date. Jamie W. Griffith{\textemdash}Remuneration for speaking engagements and research consulting. Research funding from Pfizer, the National Eczema Association, and Northwestern University. Kim Kenton: Research support Axonics, Expert witness Butler Snow/Ethicon. Emily S. Lukacz{\textemdash}Axonics: Consultant; Boston Scientific: Research funding; Cogentix/Uroplasty: Research funding; Pathnostics: Consulting/Scientific Advisory Board; Urovant: Scientific Advisory Board; UpToDate: Royalties. Elizabeth R. Mueller: UpToDate: Royalties. Diane K. Newman{\textemdash}Research funding: Society of Urology Nurses \& Associates; Patient Survey Research: Holliste; Consulting/Scientific Advisory Board; Convatec, Coloplast, COSM, EBT Medical, Urovant Sciences; Editorial: Digital Science Press. Leslie M. Rickey: UpToDate: Royalties; UroCure LLC: Quality and Safety Oversight Committee; Renovia Inc: Advisory Board. The remaining authors have no conflict of interest. Publisher Copyright: {\textcopyright} 2022 Wiley Periodicals LLC.",

year = "2023",

month = jun,

doi = "10.1002/nau.25074",

language = "English (US)",

volume = "42",

pages = "998--1010",

journal = "Neurourology and Urodynamics",

issn = "0733-2467",

publisher = "John Wiley and Sons Inc.",

number = "5",

}

TY - JOUR

T1 - RISE FOR HEALTH

T2 - Rationale and protocol for a prospective cohort study of bladder health in women

AU - For the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium

AU - Smith, Ariana L.

AU - Rudser, Kyle

AU - Harlow, Bernard L

AU - McGwin, Gerald

AU - Barthold, Julia

AU - Brady, Sonya S

AU - Brubaker, Linda

AU - Cunningham, Shayna D.

AU - Griffith, James W.

AU - Kenton, Kim

AU - Klusaritz, Heather

AU - Lewis, Cora E.

AU - Lukacz, Emily S.

AU - Maki, Julia

AU - Markland, Alayne D.

AU - Mueller, Elizabeth R.

AU - Newman, Diane K.

AU - Nodora, Jesse

AU - Rickey, Leslie M.

AU - Rockwood, Todd

AU - Simon, Melissa

AU - Wyman, Jean F

AU - Sutcliffe, Siobhan

N1 - Funding Information: We gratefully acknowledge the collegial research work of the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium members, listed below. We also acknowledge the artistic talent of the late Michele (Shelli) Quackenboss and her contribution to the RISE FOR HEALTH participant‐facing materials. For this study was provided through the following NIH awards: This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH) by cooperative agreements [U24 DK106786, U01 DK106853, U01 DK126045, U01 DK106858, U01 DK106898, U01 DK106893, U01 DK106827, U01 DK106908, U01 DK106892]. The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Funding Information: Linda Brubaker: Editorial stipends from JAMA, Female Pelvic Medicine and Reconstructive Surgery and Up to Date. Jamie W. Griffith—Remuneration for speaking engagements and research consulting. Research funding from Pfizer, the National Eczema Association, and Northwestern University. Kim Kenton: Research support Axonics, Expert witness Butler Snow/Ethicon. Emily S. Lukacz—Axonics: Consultant; Boston Scientific: Research funding; Cogentix/Uroplasty: Research funding; Pathnostics: Consulting/Scientific Advisory Board; Urovant: Scientific Advisory Board; UpToDate: Royalties. Elizabeth R. Mueller: UpToDate: Royalties. Diane K. Newman—Research funding: Society of Urology Nurses & Associates; Patient Survey Research: Holliste; Consulting/Scientific Advisory Board; Convatec, Coloplast, COSM, EBT Medical, Urovant Sciences; Editorial: Digital Science Press. Leslie M. Rickey: UpToDate: Royalties; UroCure LLC: Quality and Safety Oversight Committee; Renovia Inc: Advisory Board. The remaining authors have no conflict of interest. Publisher Copyright: © 2022 Wiley Periodicals LLC.

PY - 2023/6

Y1 - 2023/6

N2 - Introduction: The spectrum of bladder health and the factors that promote bladder health and prevent lower urinary tract symptoms (LUTS) among women are not well understood. This manuscript describes the rationale, aims, study design, sampling strategy, and data collection for the RISE FOR HEALTH (RISE) study, a novel study of bladder health in women conducted by the Prevention of Lower Urinary Tract Symptom (PLUS) Research Consortium. Methods and Results: RISE is a population-based, multicenter, prospective longitudinal cohort study of community-dwelling, English- and Spanish-speaking adult women based in the United States. Its goal is to inform the distribution of bladder health and the individual factors (biologic, behavioral, and psychosocial) and multilevel factors (interpersonal, institutional, community, and societal) that promote bladder health and/or prevent LUTS in women across the life course. Key study development activities included the: (1) development of a conceptual framework and philosophy to guide subsequent activities, (2) creation of a study design and sampling strategy, prioritizing diversity, equity, and inclusion, and (3) selection and development of data collection components. Community members and cross-cultural experts shaped and ensured the appropriateness of all study procedures and materials. RISE participants will be selected by simple random sampling of individuals identified by a marketing database who reside in the 50 counties surrounding nine PLUS clinical research centers. Participants will complete self-administered surveys at baseline (mailed paper or electronic) to capture bladder health and LUTS, knowledge about bladder health, and factors hypothesized to promote bladder health and prevent LUTS. A subset of participants will complete an in-person assessment to augment data with objective measures including urogenital microbiome specimens. Initial longitudinal follow-up is planned at 1 year. Discussion: Findings from RISE will begin to build the necessary evidence base to support much-needed, new bladder health promotion and LUTS prevention interventions in women.

AB - Introduction: The spectrum of bladder health and the factors that promote bladder health and prevent lower urinary tract symptoms (LUTS) among women are not well understood. This manuscript describes the rationale, aims, study design, sampling strategy, and data collection for the RISE FOR HEALTH (RISE) study, a novel study of bladder health in women conducted by the Prevention of Lower Urinary Tract Symptom (PLUS) Research Consortium. Methods and Results: RISE is a population-based, multicenter, prospective longitudinal cohort study of community-dwelling, English- and Spanish-speaking adult women based in the United States. Its goal is to inform the distribution of bladder health and the individual factors (biologic, behavioral, and psychosocial) and multilevel factors (interpersonal, institutional, community, and societal) that promote bladder health and/or prevent LUTS in women across the life course. Key study development activities included the: (1) development of a conceptual framework and philosophy to guide subsequent activities, (2) creation of a study design and sampling strategy, prioritizing diversity, equity, and inclusion, and (3) selection and development of data collection components. Community members and cross-cultural experts shaped and ensured the appropriateness of all study procedures and materials. RISE participants will be selected by simple random sampling of individuals identified by a marketing database who reside in the 50 counties surrounding nine PLUS clinical research centers. Participants will complete self-administered surveys at baseline (mailed paper or electronic) to capture bladder health and LUTS, knowledge about bladder health, and factors hypothesized to promote bladder health and prevent LUTS. A subset of participants will complete an in-person assessment to augment data with objective measures including urogenital microbiome specimens. Initial longitudinal follow-up is planned at 1 year. Discussion: Findings from RISE will begin to build the necessary evidence base to support much-needed, new bladder health promotion and LUTS prevention interventions in women.

KW - bladder health

KW - epidemiology

KW - health promotion

KW - longitudinal study

KW - lower urinary tract symptoms

KW - social ecological framework

KW - women's health

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UR - https://www.scopus.com/pages/publications/85141436960#tab=citedBy

U2 - 10.1002/nau.25074

DO - 10.1002/nau.25074

M3 - Article

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AN - SCOPUS:85141436960

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SP - 998

EP - 1010

JO - Neurourology and Urodynamics

JF - Neurourology and Urodynamics

IS - 5

ER -

RISE FOR HEALTH: Rationale and protocol for a prospective cohort study of bladder health in women

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