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Increasing Decision Quality for Men With Lower Urinary Tract Symptoms

Increasing Decision Quality in Older Men in Selecting Treatment Options for Lower Urinary Tract Symptoms (LUTS): A Pilot Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04851275
Enrollment
60
Registered
2021-04-20
Start date
2019-04-15
Completion date
2020-03-31
Last updated
2021-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Engagement, Patient Preference

Brief summary

In this study, the investigators show that by upskilling of primary care physicians (PCPs) in SDM and leveraging on a novel pictorial Visual Analogue Uroflowmetry Score (VAUS), they can enhance older men's recognition of LUTS and stimulated discussion with their PCPs.

Detailed description

Lower urinary tract symptoms (LUTS), often related to prostatomegaly, is common but seldom sought medical attention amongst older men. Visual-aid and shared decision-making (SDM) are potential solutions to address LUTS. The study aimed to determine the effect of a novel pictorial Visual Analogue Uroflowmetry Score (VAUS) and primary care physicians (PCP) SDM training on the decisional quality amongst men selecting their treatment options for LUTS. This study recruited 60 multi-ethnic Asian men aged ≥50 years with moderate-to-severe LUTS (International Prostate Symptoms Score≥8 and/or QOL≥3) in a Singapore public primary care clinic. Men used the VAUS to report their symptoms. 60 men were randomly assigned to PCPs trained in SDM in the intervention group (n=30) and the other 30 to the control group (PCPs without SDM-training). Patient-physician dyad decision quality was measured using the validated SDMQ-9 (patient) and SDMQ-Doc (physician) questionnaires.

Interventions

BEHAVIORALPhysicians trained in shared decision making

Physicians in this group were trained in shared decision making

BEHAVIORALPhysicians were not trained in shared decision making

Physicians did not receive training in shared decision making

Sponsors

Singapore General Hospital
CollaboratorOTHER
SingHealth Polyclinics
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* men aged 50 years old and older attending the polyclinic for routine follow up of a chronic disease (non-communicable disease) * have moderate-to-severe LUTS and/or poor quality of life (QOL) as assessed by the validated International Prostate Symptom Score (IPSS) of eight or more and/or its individual QOL score of three or more * men of any local Asian ethnicity and were willing to provide written consent * can communicate with their allocated PCP in either of the three main local languages; English, Mandarin or Malay.

Exclusion criteria

* have indwelling catheters * urinary incontinence requiring diapers * anuria due to any renal pathology * gross hematuria * acute urinary retention * symptoms consistent with an acute urinary tract infection * existing treatment of LUTS or other prostate pathology * visual or hearing impairment which render men incapable of understanding the study procedure and providing informed consent * men unwilling to discuss their LUTS treatment options with their PCP

Design outcomes

Primary

MeasureTime frameDescription
Quality of the decision on the management of lower urinary tract symptoms from the patients' perspectiveThrough study completion, an average of 6 monthsThe Shared Decision Making-9 (SDMQ9) Questionnaire measures decision quality from the perspective of the patient. Nine individual items in the questionnaire is scored from 0 to 5 on a six-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Standard scoring for the full scale is the total score, with values from 0 to 45. Higher scores indicate higher quality decisions.
Quality of the decision on the management of lower urinary tract symptoms from the physicians' perspectiveThrough study completion, an average of 6 monthsThe Shared Decision Making-Doctor (SDMQDoc) Questionnaire measures decision quality from the perspective of the physician. Nine individual items in the questionnaire is scored from 0 to 5 on a six-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Standard scoring for the full scale is the total score, with values from 0 to 45. Higher scores indicate higher quality decisions.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026