Validation of Bladder Health Instrument for Evaluation in Women (VIEW)

General Description

The Prevention of Lower Urinary Symptoms (PLUS) Research Consortium sought to optimize prevention of lower urinary tract symptoms (LUTS) in women and adolescent females across their life spans. The ability to measure bladder health and key risk and protective factors was crucial to the PLUS mission. To describe and measure the spectrum of bladder health in diverse populations, researchers needed a valid and reliable instrument. Prior to the Validation of Bladder Health Instrument for Evaluation in Women (VIEW) study, the PLUS Consortium’s work on the design of a bladder health instrument was a culmination of expert opinion, information from focus groups, and incorporation of previously validated items and language where appropriate, along with cognitive interviews of participants from the general public. The VIEW study prospectively collected data to test and validate bladder health instrument (BHI) items for inclusion in a final bladder health scale (BHS) that assessed the full range of bladder health of women. The study collected data from the general population using mailed surveys, from the clinical population using surveys and in-person evaluations, and from postpartum women.

Objectives

The primary objective of the VIEW study was to validate a novel bladder health instrument to measure the spectrum of bladder health from very healthy to very unhealthy in population-based and clinical research. Multi-item measurement was used to assess the range of bladder health dimensions as defined by the model of bladder health adopted by the PLUS Consortium. The items covered the range of bladder health dimensions specified by the model.

Outcome Measure

Construct validity of the bladder health scales and function indices was guided by a multitrait-multimethod approach using health and condition-specific questionnaires, bladder diaries, expert ratings of bladder health, and non-invasive bladder function testing.

Criteria

The following were inclusion and exclusion criteria for the general population sample:

Inclusion criteria:

• Community dwelling
• Age ≥ 18 years old
• Female sex assigned at birth
• Fluent in written and spoken English
• Able to read and provide informed consent

Exclusion criteria:

• Institutional living arrangement (e.g., skilled nursing, long term care, or rehabilitation center)
• Physical or mental condition that would prohibit self-administration of questionnaire either electronically or using paper and pencil (e.g., dementia/cognitive impairment/blindness/severe arthritis)

The following were the inclusion and exclusion criteria for the participants recruited from the clinical research centers:

Inclusion criteria:

• Community dwelling
• Age ≥ 18 years old
• Female sex assigned at birth
• Fluent in written and spoken English
• Able to read and provide informed consent
• Stand independently without human assist (e.g., cane/walker okay) for up to 3 minutes
• Get to bathroom and use toilet on own without help from another person
• Willing to complete BHI validation survey and 2-day Bladder Health Symptom diary and 1-day Bladder Health Frequency-Volume diary prior to in-person clinical evaluation
• Available and willing to commit to an in-person evaluation within 8 weeks of enrollment
• Pregnant in 3rd trimester or recently postpartum (for postpartum group only)
• Available and willing to come for an in-person evaluation within 8-12 weeks postpartum (may be enrolled prior to delivery; for postpartum group only)

Exclusion criteria:

• Physical or mental condition that would prohibit self-administration of questionnaire either electronically or using paper and pencil (e.g., dementia/cognitive impairment/blindness/severe arthritis)
• Institutional living arrangement (e.g., skilled nursing, long term care, or rehabilitation center)
• Pregnant at the time of data collection
• Diagnosis or history of bladder cancer, kidney transplant, pelvic radiation, or currently getting dialysis
• Unable to stand and toilet independently
• Current participation in a research study about bladder

Outcome

The paper and electronic forms of the bladder health scales and function indices were reliable and valid measures of bladder health for use in non-postpartum women's health research.