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

Primary Purpose

Lower Urinary Tract Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
URincontrol4men
Care as usual
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring Lower urinary tract symptoms, eHealth, Self-management, Primary care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center GroningenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Care as usual

Online self-management intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

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; voding symptoms (range 0 -20) and incontinence symptoms (range 0-24) with higher scores indicating more symptoms.
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.
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.
iMTA Medical Consumption Questionnaire (iMCQ)
Costs of medical consumption
iMTA Productivity Cost Questionnaire (iPCQ)
Costs of productivity losses

Full Information

First Posted
April 1, 2022
Last Updated
April 28, 2022
Sponsor
University Medical Center Groningen
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Bekkenbodem4All, Leiden University Medical Center, University of Twente, Isala
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1. Study Identification

Unique Protocol Identification Number
NCT05356260
Brief Title
Self-management Compared to Care-as-usual for Men With Lower Urinary Tract Symptoms
Official Title
URincontrol4men: Self-management Through an App, Compared to the Consultation of a General Practitioner for Men With Lower Urinary Tract Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Bekkenbodem4All, Leiden University Medical Center, University of Twente, Isala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms
Keywords
Lower urinary tract symptoms, eHealth, Self-management, Primary care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic non-inferiority randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
698 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Care as usual
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Online self-management intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
URincontrol4men
Intervention Description
The intervention is built as an app
Intervention Type
Other
Intervention Name(s)
Care as usual
Intervention Description
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 Outcome Measure Information:
Title
The Patient Global Impression of Improvement (PGI-I)
Description
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."
Time Frame
6 months
Secondary Outcome Measure Information:
Title
International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)
Description
The ICIQ-MLUTS is a questionnaire for evaluating male lower urinary tract symptoms and impact on quality of life. Its has two subscales; voding symptoms (range 0 -20) and incontinence symptoms (range 0-24) with higher scores indicating more symptoms.
Time Frame
6 weeks and 6 months
Title
International Prostate Symptom Score Quality of Life (IPSS QoL)
Description
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.
Time Frame
6 weeks and 6 months
Title
the EuroQol instrument (EQ-5D-5L)
Description
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.
Time Frame
6 weeks and 6 months
Title
iMTA Medical Consumption Questionnaire (iMCQ)
Description
Costs of medical consumption
Time Frame
6 months
Title
iMTA Productivity Cost Questionnaire (iPCQ)
Description
Costs of productivity losses
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margreet Tieks
Phone
+31 50 361 5020
Email
m.m.tieks@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Henk van der Worp
Email
h.van.der.worp@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Blanker
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margreet Tieks, Msc
Email
m.m.tieks@umcg.nl
First Name & Middle Initial & Last Name & Degree
Henk van der Worp, PhD
Email
h.van.der.worp@umcg.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The processed, anonymised data will be made available in DataverseNL and a persistent identifier to a minimal dataset(s) will be given in the publication(s).
IPD Sharing Time Frame
After publishing of the manuscripts related to this study
IPD Sharing 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.

Learn more about this trial

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

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