Self-management Compared to Care-as-usual for Men With Lower Urinary Tract Symptoms

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05356260
• Other study ID #: ZonMW 852002125
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 8, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

Device:
• URincontrol4men
The intervention is built as an app

Other:
• 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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (6)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

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