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Active, Not Recruiting

NCT Number: NCT05356260

Self-management Compared to Care-as-usual 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

URincontrol4men

Device

The intervention is built as an app

Care as usual

Other

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.

Primary outcomes

  1. The Patient Global Impression of Improvement (PGI-I)

    Time frame: 6 months

    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."

Secondary outcomes

  1. International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)

    Time frame: 6 weeks and 6 months

    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.

  2. International Prostate Symptom Score Quality of Life (IPSS QoL)

    Time frame: 6 weeks and 6 months

    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.

  3. the EuroQol instrument (EQ-5D-5L)

    Time frame: 6 weeks and 6 months

    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.

  4. iMTA Medical Consumption Questionnaire (iMCQ)

    Time frame: 6 months

    Costs of medical consumption

  5. iMTA Productivity Cost Questionnaire (iPCQ)

    Time frame: 6 months

    Costs of productivity losses

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Bekkenbodem4All
  • Isala
  • Leiden University Medical Center
  • University of Twente
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

URincontrol4men: Self-management Through an App, Compared to the Consultation of a General Practitioner for Men With Lower Urinary Tract Symptoms

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 2, 2022
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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