Self-management Compared to Care-as-usual for Men With Lower Urinary Tract Symptoms
URincontrol4men: Self-management Through an App, Compared to the Consultation of a General Practitioner for Men With Lower Urinary Tract Symptoms
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Groningen, Netherlands, 9713GZ
- University Medical Center Groningen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Care as usual
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.
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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.
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|
Experimental: Online self-management intervention
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.
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The intervention is built as an app
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Patient Global Impression of Improvement (PGI-I)
Time Frame: 6 months
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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."
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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International Prostate Symptom Score Quality of Life (IPSS QoL)
Time Frame: 6 weeks and 6 months
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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.
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6 weeks and 6 months
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the EuroQol instrument (EQ-5D-5L)
Time Frame: 6 weeks and 6 months
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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.
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6 weeks and 6 months
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iMTA Medical Consumption Questionnaire (iMCQ)
Time Frame: 6 months
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Costs of medical consumption
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6 months
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iMTA Productivity Cost Questionnaire (iPCQ)
Time Frame: 6 months
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Costs of productivity losses
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6 months
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International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)
Time Frame: 6 weeks and 6 months
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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.
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6 weeks and 6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marco Blanker, University Medical Center Groningen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZonMW 852002125
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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