Skip to main content
OpenTrials
Completed

NCT Number: NCT04851275

Increasing Decision Quality for Men With Lower Urinary Tract Symptoms

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patient Engagement Behavior Health Behavior Patient Acceptance of Health Care Patient Participation Patient Preference Patient Satisfaction Treatment Adherence and Compliance

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Haidee Ngu

Singapore, 150167

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physicians trained in shared decision making

Behavioral

Physicians in this group were trained in shared decision making

Physicians were not trained in shared decision making

Behavioral

Physicians did not receive training in shared decision making

Primary outcomes

  1. Quality of the decision on the management of lower urinary tract symptoms from the patients' perspective

    Time frame: Through study completion, an average of 6 months

    The 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.

  2. Quality of the decision on the management of lower urinary tract symptoms from the physicians' perspective

    Time frame: Through study completion, an average of 6 months

    The 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.

Sponsors and collaborators

Lead sponsor

SingHealth Polyclinics

Other

Collaborators

  • Singapore General Hospital

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 20, 2021
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.