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

NCT ID: NCT05356260

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-08

Study Completion Date

2024-12-05

Brief Summary

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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

Detailed Description

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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.

Conditions

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Lower Urinary Tract Symptoms

Keywords

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Lower urinary tract symptoms eHealth Self-management Primary care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic non-inferiority randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Care as usual

Intervention Type 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.

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.

Group Type EXPERIMENTAL

URincontrol4men

Intervention Type DEVICE

The intervention is built as an app

Interventions

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URincontrol4men

The intervention is built as an app

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Bekkenbodem4All

UNKNOWN

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role collaborator

University of Twente

OTHER

Sponsor Role collaborator

Isala

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Blanker

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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ZonMW 852002125

Identifier Type: -

Identifier Source: org_study_id