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

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.

Study Overview

• Status: Completed
• Conditions: Patient Engagement; Patient Preference
• Intervention / Treatment: Behavioral: Physicians trained in shared decision making; Behavioral: Physicians were not trained in shared decision making

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 150167
    • Haidee Ngu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shared decision making for men with lower urinary tract symptoms; Participants used the Visual Analogue Uroflowmetry Score so report their symptoms and were attended by Primary Care Physicians trained in shared decision making	Behavioral: Physicians trained in shared decision making; Physicians in this group were trained in shared decision making
Active Comparator: No shared decision making for men with lower urinary tract symptoms; Participants did not use the Visual Analogue Uroflowmetry Score to report their symptoms and received usual care by Primary Care Physicians not trained in shared decision making	Behavioral: Physicians were not trained in shared decision making; Physicians did not receive training in shared decision making

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of the decision on the management of lower urinary tract symptoms from the patients' perspective	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.	Through study completion, an average of 6 months
Quality of the decision on the management of lower urinary tract symptoms from the physicians' perspective	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.	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: SingHealth Polyclinics
• Collaborators: Singapore General Hospital
• Investigators: Study Director: Tan Ngiap Chuan, MBBS, Singhealth polyclinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 2018/3106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No