Clinical trial NCT04851275: Increasing Decision Quality for Men With Lower Urinary Tract Symptoms
Official title: Increasing Decision Quality in Older Men in Selecting Treatment Options for Lower Urinary Tract Symptoms (LUTS): A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Engagement
Patient Preference
Lead sponsor: SingHealth Polyclinics
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
First posted: 2021-04-20
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of the decision on the management of lower urinary tract symptoms from the patients' perspective
timeFrame: Through study completion, an average of 6 months
measure: Quality of the decision on the management of lower urinary tract symptoms from the physicians' perspective
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Haidee Ngu
Study officials:
affiliation: Singhealth polyclinic
name: Tan Ngiap Chuan, MBBS
role: STUDY_DIRECTOR
References:
citation: Tiwari R, Ng MY, Neo SH, Mangat R, Ho H. Prospective validation of a novel visual analogue uroflowmetry score (VAUS) in 1000 men with lower urinary tract symptoms (LUTS). World J Urol. 2020 May;38(5):1267-1273. doi: 10.1007/s00345-019-02909-1. Epub 2019 Aug 27.