An interventional study of URincontrol4men and Care as usual in Lower Urinary Tract Symptoms, sponsored by University Medical Center Groningen. Active, not recruiting at 1 site in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Treatment
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
Rationale: Although self-management can be difficult to implement because it is time consuming to explain, it has proven effective for LUTS. For this reason, we developed an online intervention that can be used at home by men with LUTS, giving tailored advice to each case. Objective: To assess the effectiveness and cost-effectiveness of providing an online personalized self-management program as a first-line intervention to men with lower urinary tract symptoms (LUTS) compared to care as usual (CAU).
Study design: A pragmatic non-inferiority randomized controlled trial in the general population. Study population: Men with LUTS (>18 years of age) who are considering visiting a general practitioner for their complaints.
Intervention: Access to an online program offering personalized selfmanagement advice compared to care as usual Main endpoints: Outcomes will be assessed at 6 weeks, 3 months and 6 months.
406 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's enrollment of 175 is above the median of 93 across 260 interventional studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
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Exclusion Criteria:
CAU will be that typically provided by GPs. Also patients will be informed about a page on thuisarts.nl regarding male LUTS. The pragmatic trial design means that care can vary depending on the preferences of patients and GPs in this group.
Other: Care as usual
Participants in the intervention group will be given access to an online self-management program that will be personalized. This program was developed based on the results of a literature search, the opinions of expert Dutch GPs and urologists, and a pilot study in secondary care, with further preliminary testing in primary care. The program consists of nine components: information, pelvic floor exercises, bladder training, sitting voiding position, urethral milking, fluid management, caffeine avoidance, alcohol avoidance, and physical activity increase. Information is presented as text with supportive figures, plus audio (a "read aloud function" for all text) and video fragments to facilitate engagement by men with low literacy levels.
Device: URincontrol4men
The intervention is built as an app
CAU will be that typically provided by GPs. Also patients will be informed about a page on thuisarts.nl regarding male LUTS. The pragmatic trial design means that care can vary depending on the preferences of patients and GPs in this group.
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."
Time frame: 6 months
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.
Time frame: 6 weeks and 6 months
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.
Time frame: 6 weeks and 6 months
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.
Time frame: 6 weeks and 6 months
iMTA Medical Consumption Questionnaire (iMCQ)
Costs of medical consumption
Time frame: 6 months
iMTA Productivity Cost Questionnaire (iPCQ)
Costs of productivity losses
Time frame: 6 months
Plan to share: Yes — The processed, anonymised data will be made available in DataverseNL and a persistent identifier to a minimal dataset(s) will be given in the publication(s).
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University Medical Center Groningen