Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04016298 · ClinicalTrials.gov registry record
Validation of Bladder Health Instrument for Evaluation in Women
A clinical trial, sponsored by University of Minnesota.
- Completed
- Registry status
- 1,222
- Enrollment target
NCT04016298: Completed study, sponsored by University of Minnesota.
NCT04016298 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 1,222 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04016298 has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- 1,222 participants
- Enrollment target
Study Summary
The Prevention of Lower Urinary Symptoms (PLUS) Research Consortium is working 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 is crucial to the PLUS mission. To describe and measure the spectrum of bladder health in diverse populations, researchers need a valid and reliable instrument. To date, the Consortium's work on design of a bladder health instrument has been 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 next step in the consortium's work is to prospectively collect data to test and validate bladder health instrument (BHI) items for inclusion in a final bladder health scale (BHS) that can assess the full range of bladder health of women. This will be through a combination of general population recruitment for completing mailed surveys, clinical population recruitment for completing surveys and an in-person evaluation, and postpartum women.
Primary Outcome
Multi-item measurement is used to assess the range of bladder health dimensions as defined by the model of bladder health adopted by the PLUS consortium. It is anticipated that the self-administeredBHI instrument (PAPI or CASI) will consist of approximately 85 items: 53-67 are items all respondents will be asked to answer, and 48 are asked only of women who self-identify as experiencing a specific LUTS. The items cover the range of bladder health dimensions specified by our model.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,222 participants |
| Start Date | 2019-07-31 |
| Est. Completion | 2022-05-25 |
What the finished NCT04016298 record still lists
NCT04016298 is an observational study that tracks outcomes without assigning an intervention. Its 1,222 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT04016298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04016298 about?
NCT04016298 is a clinical study titled "Validation of Bladder Health Instrument for Evaluation in Women". The Prevention of Lower Urinary Symptoms (PLUS) Research Consortium is working 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 is crucial to the PLUS missi...
What is the current status of trial NCT04016298?
This trial is currently completed. The enrollment target is 1,222 participants. The study started on 2019-07-31. Estimated completion is 2022-05-25.
Who is sponsoring clinical trial NCT04016298?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06921785 · 1,220 participants · Phase 3
Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma
- NCT06143956 · 1,217 participants · Phase 2
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
- NCT05827016 · 1,216 participants · Phase 3
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma
- NCT05946044 · 1,230 participants · NA
The Osteoarthritis Prevention Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI