Management of LUTS by Community Pharmacists

NCT04331340 | Completed

• 1 other identifier: Pro00097144
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Many older adults have urinary incontinence. They often seek treatments, such as diapers, pads, or medications, from the community pharmacy. Pharmacists are trained to assist seniors with therapies that treat urinary incontinence. Our study will determine how much benefit there is if pharmacists try to provide more assistance for seniors with incontinence. Over a period of months, half of the people who talk to the pharmacist about their incontinence will be given general information about health and aging. The other half of the people will have a longer assessment and complete a questionnaire with the pharmacist. Then the pharmacist will call and have a follow-up visit to see how the incontinence symptoms have improved. We will compare both groups to see whose symptoms were improved.

Conditions

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• Change in Patient Perception of Bladder Condition (PPBC)

  Questionnaire to assess patient perception of LUTS severity Scored from 1-6; 1 = problems, 6=severe problems

  Change from baseline to 8 weeks post-intervention

Secondary Outcomes (2)

• Change in Bladder Self-Assessment Questionnaire (B-SAQ)

  Change from baseline to 8 weeks post-intervention

• Change in International Consultation on Incontinence Module Questionnaire Short Form (ICI-Q-SF)

  Change from baseline to 8 weeks post-intervention

Study Arms (2)

Pharmacist Intervention

EXPERIMENTAL

Pharmacist assessment of LUTS, with recommendations and education regarding lifestyle, behaviour, and/or medications related to bladder health. Follow-up at 3 and 6 weeks.

Other: Pharmacist review of LUTS

Control

ACTIVE COMPARATOR

Pharmacist questions regarding presence of LUTS, with provision of healthy aging literature. Follow-up at 6 weeks.

Other: Pharmacist Provision of healthy aging leaflets

Interventions

Pharmacist review of LUTS OTHER

Pharmacist review and recommendations, including education, behaviour, lifestyle, or medications

Pharmacist Intervention

Pharmacist Provision of healthy aging leaflets OTHER

Pharmacist will inquire about presence of LUTS and provide patient with healthy aging leaflets

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60 years
• Report lower urinary tract symptoms (LUTS)
• Read and communicate in English

You may not qualify if:

• Age ≤ 59 years
• Deny LUTS
• Refuse to consent
• Unavailable or unable to participate in follow-up visits

Sponsors & Collaborators

• University of Alberta: lead
• Pfizer: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G1C9, Canada

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cheryl A Sadowski, Pharm.D.

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 2, 2020
• Study Start: April 26, 2021
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of the study in 2021, for 5 years.

Locations

CA (1)