Lower Urinary Tract Symptoms Clinical Trial
Official title:
URincontrol4men: Self-management Through an App, Compared to the Consultation of a General Practitioner for Men With Lower Urinary Tract Symptoms
Verified date | May 2024 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Research question: Does offering an online self-management program lead to more efficient use of care by men with urinary complaints? Hypothesis: Many men with urinary symptoms receive medication from their GP. Advice on how to self-manage complaints is often skipped. This while self-management is effective. By offering self-management instead of visiting a GP the use of care by men with urinary complaints may decrease and treatment may become more efficient. Study design: Men are randomized to receive either care-as-usual by their GP or the online self-management program. Men will be followed for six months and the cost-effectiveness of the online self-management intervention will be compared to the care-as-usual
Status | Active, not recruiting |
Enrollment | 175 |
Est. completion date | December 31, 2024 |
Est. primary completion date | November 10, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men with lower urinary tract symptoms who are thinking about visiting a GP for their complaints Exclusion Criteria: - Men with complicated LUTS who should seek urgent care, including those with nocturnal incontinence (e.g., chronic urinary retention), the inability to void despite urgency (e.g., acute urinary retention), and with sudden onset or worsening LUTS (e.g., urinary tract infections). - Men receiving treatment from a pelvic physiotherapist, GP, or urologist (including at any point in the previous year). - Men with a history of prostate cancer, bladder cancer, or urinary tract surgery |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen | Bekkenbodem4All, Isala, Leiden University Medical Center, University of Twente, ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Patient Global Impression of Improvement (PGI-I) | The PGII is a single-question global index for change of incontinence symptoms that is rated with a 7-point Likert scale ranging from "very much worse" to "very much better." This variable will be dichotomized into "improved" (scores = "better") and "not improved." | 6 months | |
Secondary | International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS) | The ICIQ-MLUTS is a questionnaire for evaluating male lower urinary tract symptoms and impact on quality of life. Its has two subscales; voiding symptoms (range 0 -20) and incontinence symptoms (range 0-24) with higher scores indicating more symptoms. | 6 weeks and 6 months | |
Secondary | International Prostate Symptom Score Quality of Life (IPSS QoL) | International Prostate Symptom Score (single item) quality of life. The score ranges from 0 - 6 with a higher score indicating a lower quality of life. | 6 weeks and 6 months | |
Secondary | the EuroQol instrument (EQ-5D-5L) | The EQ-5D-5L is s generic quality of life questionnaire. Utilities can be calculated from this questionnaire with a maximum score of 1 indicating a perfect health state. | 6 weeks and 6 months | |
Secondary | iMTA Medical Consumption Questionnaire (iMCQ) | Costs of medical consumption | 6 months | |
Secondary | iMTA Productivity Cost Questionnaire (iPCQ) | Costs of productivity losses | 6 months |
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