Lower Urinary Tract SymptomsNCT04331340
Management of LUTS by Community Pharmacists
A study testing Pharmacist review of LUTS and Pharmacist Provision of healthy aging leaflets in people with Lower Urinary Tract Symptoms, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Pharmacist review of LUTS and Pharmacist Provision of healthy aging leaflets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 26 Apr 2021to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥60 years
- Report lower urinary tract symptoms (LUTS)
- Read and communicate in English
Who cannot join
- Age ≤ 59 years
- Deny LUTS
- Refuse to consent
- Unavailable or unable to participate in follow-up visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Project to Address Lower Urinary Tract Symptoms (LUTS) by Pharmacists in the Community
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.
Read the detailed description
This randomized controlled trial is designed to determine the effect of a pharmacist intervention to manage lower urinary tract symptoms (LUTS) in the community. The objectives of the study are to determine the effect of the pharmacist as measured by the Patient Perception of Bladder Condition (PPBC) (primary objective), the Bladder Self-Assessment Questionnaire (B-SAQ), and the International Consultation on Incontinence Module Questionnaire Short Form (ICI-Q-SF) (as secondary objectives).
The pharmacists at community pharmacies will be recruited through the networks already established within Alberta for pharmacy practice research, and the Pharmacists Association of Alberta. The pharmacists must have advanced prescribing authorization with their professional license.
The patients will be recruited with the posting of shelf-talkers by the incontinence and menstrual products section of the pharmacy and with leaflets in prescription bags. If a patient obtains a LUTS product or if the patient presents him/herself in response to the shelf-talker, the pharmacist will screen the patient to determine if LUTS are present.The patients will be eligible to participate if they are at least 60 years of age, report LUTS, can communicate in English, and provide consent.
The patient will be randomized to either a control or intervention. Those assigned to the control group will be eligible to receive the intervention following the follow-up period. Both the control and intervention group will have a baseline PPBC, B-SAQ, and ICI-Q-SF questionnaires, in addition to demographics and a medical history.
The control group will receive a healthy aging pamphlet and will be called back at 8 weeks to have the questionnaires repeated.
The intervention is based on the published guide for LUTS for pharmacists (Gabriel, et al. 2015). The pharmacist will assess the patient's LUTS and determine an appropriate intervention plan, which may include education, lifestyle, behavioural, or medication modification. The patient will be given a summary of the plan and the primary care provider will also receive a summary. At 4 weeks the patient will be contacted by phone or in person (per patient preference), with a review of the plan and repeated bladder questionnaires. At 8 weeks the patient will complete the final interaction with the pharmacist and will complete the bladder questionnaires for the final time.
The primary outcome is the change in PPBC from baseline to 8 weeks, and secondary outcomes include the change from baseline until 8 weeks in the B-SAQ, ICI-Q, and health system use (including referrals to physicians, specialists, and pharmacist billing).
We plan to enroll 100 patients (50 in each group). All analyses will be by intention to treat.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Pharmacist review of LUTS, Pharmacist Provision of healthy aging leaflets
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist review of LUTSOther
Pharmacist review and recommendations, including education, behaviour, lifestyle, or medications
Pharmacist Provision of healthy aging leafletsOther
Pharmacist will inquire about presence of LUTS and provide patient with healthy aging leaflets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pharmacist Provision of healthy aging leaflets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline to 8 weeks post-intervention
Secondary outcomes (2)
Change in Bladder Self-Assessment Questionnaire (B-SAQ)
Self-administered questionnaire to assess types of symptoms and extent of bother Scored for Bother 0-12; 0=no bother, 12 = bothers a great deal Scored for Symptoms 0-12; 0=no symptoms, 3=severe symptoms
Measured: Change from baseline to 8 weeks post-intervention
Change in International Consultation on Incontinence Module Questionnaire Short Form (ICI-Q-SF)
Self- administered questionnaire to describe extent and severity of LUTS Scored from 0-21; 0= no impact or leakage; 21 = severe leakage and interference
Measured: Change from baseline to 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start26 Apr 2021
- Primary completion30 Jun 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Cheryl A Sadowski, Pharm.D., Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331340
- Sponsor's protocol ID
- Pro00097144
- Status last verified
- Sep 2024
- First submitted
- 23 Mar 2020
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Subject demographics and scores of the primary and secondary outcomes measures will be shared at all time points.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Project to Address Lower Urinary Tract Symptoms (LUTS) by Pharmacists in the Community
- ClinicalTrials.gov ID
- NCT04331340
- Acronym / sponsor ID
- Pro00097144
- Conditions
- Lower Urinary Tract Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized controlled trial is designed to determine the effect of a pharmacist intervention to manage lower urinary tract symptoms (LUTS) in the community. The objectives of the study are to determine the effect of the pharmacist as measured by the Patient Perception of Bladder Condition (PPBC) (primary objective), the Bladder Self-Assessment Questionnaire (B-SAQ), and the International Consultation on Incontinence Module Questionnaire Short Form (ICI-Q-SF) (as secondary objectives).
The pharmacists at community pharmacies will be recruited through the networks already established within Alberta for pharmacy practice research, and the Pharmacists Association of Alberta. The pharmacists must have advanced prescribing authorization with their professional license.
The patients will be recruited with the posting of shelf-talkers by the incontinence and menstrual products section of the pharmacy and with leaflets in prescription bags. If a patient obtains a LUTS product or if the patient presents him/herself in response to the shelf-talker, the pharmacist will screen the patient to determine if LUTS are present.The patients will be eligible to participate if they are at least 60 years of age, report LUTS, can communicate in English, and provide consent.
The patient will be randomized to either a control or intervention. Those assigned to the control group will be eligible to receive the intervention following the follow-up period. Both the control and intervention group will have a baseline PPBC, B-SAQ, and ICI-Q-SF questionnaires, in addition to demographics and a medical history.
The control group will receive a healthy aging pamphlet and will be called back at 8 weeks to have the questionnaires repeated.
The intervention is based on the published guide for LUTS for pharmacists (Gabriel, et al. 2015). The pharmacist will assess the patient's LUTS and determine an appropriate intervention plan, which may include education, lifestyle, behavioural, or medication modification. The patient will be given a summary of the plan and the primary care provider will also receive a summary. At 4 weeks the patient will be contacted by phone or in person (per patient preference), with a review of the plan and repeated bladder questionnaires. At 8 weeks the patient will complete the final interaction with the pharmacist and will complete the bladder questionnaires for the final time.
The primary outcome is the change in PPBC from baseline to 8 weeks, and secondary outcomes include the change from baseline until 8 weeks in the B-SAQ, ICI-Q, and health system use (including referrals to physicians, specialists, and pharmacist billing).
We plan to enroll 100 patients (50 in each group). All analyses will be by intention to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Intervention | Experimental | Other: Pharmacist review of LUTSPharmacist assessment of LUTS, with recommendations and education regarding lifestyle, behaviour, and/or medications related to bladder health. Follow-up at 3 and 6 weeks. |
| Control | Active comparator | Other: Pharmacist Provision of healthy aging leafletsPharmacist questions regarding presence of LUTS, with provision of healthy aging literature. Follow-up at 6 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥60 years
- Report lower urinary tract symptoms (LUTS)
- Read and communicate in English
Key exclusion criteria (4 listed)
- Age ≤ 59 years
- Deny LUTS
- Refuse to consent
- Unavailable or unable to participate in follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist review of LUTSPharmacist review and recommendations, including education, behaviour, lifestyle, or medications | Other | Pharmacist Intervention |
| Pharmacist Provision of healthy aging leafletsPharmacist will inquire about presence of LUTS and provide patient with healthy aging leaflets | Other | Control |
Primary outcome
Change in Patient Perception of Bladder Condition (PPBC)
Time frame: Change from baseline to 8 weeks post-intervention
Questionnaire to assess patient perception of LUTS severity Scored from 1-6; 1 = problems, 6=severe problems
2 secondary outcomes
Change in Bladder Self-Assessment Questionnaire (B-SAQ)
Time frame: Change from baseline to 8 weeks post-intervention
Change in International Consultation on Incontinence Module Questionnaire Short Form (ICI-Q-SF)
Time frame: Change from baseline to 8 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: Yes. Subject demographics and scores of the primary and secondary outcomes measures will be shared at all time points.
Related trials for Lower Urinary Tract Symptoms
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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl A Sadowski, Pharm.D. principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist review of LUTS and Pharmacist Provision of healthy aging leaflets in people with Lower Urinary Tract Symptoms, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Perception of Bladder Condition (PPBC) (time frame: Change from baseline to 8 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.