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

NCT05356260 | Active Not Recruiting DMC

• 1 other identifier: ZonMW 852002125
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lower Urinary Tract Symptoms

Keywords

Lower urinary tract symptoms; eHealth; Self-management; Primary care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  6 weeks and 6 months

• International Prostate Symptom Score Quality of Life (IPSS QoL)

  6 weeks and 6 months

• the EuroQol instrument (EQ-5D-5L)

  6 weeks and 6 months

• iMTA Medical Consumption Questionnaire (iMCQ)

  6 months

• iMTA Productivity Cost Questionnaire (iPCQ)

  6 months

Study Arms (2)

Care as usual

ACTIVE COMPARATOR

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

Online self-management intervention

EXPERIMENTAL

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

Interventions

URincontrol4men DEVICE

The intervention is built as an app

Online self-management intervention

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.

Care as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men with lower urinary tract symptoms who are thinking about visiting a GP for their complaints

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Blanker

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic non-inferiority randomized controlled trial

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: May 2, 2022
• Study Start: April 8, 2022
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publishing of the manuscripts related to this study
• Access Criteria: Requests for re-use of data will be evaluated by the Principal Investigator who will check whether the research question falls within the scope of the informed consent. There will be terms and conditions drawn up in a contract for re-using data by third parties.

Locations

NL (1)