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Deprescribing Tamsulosin in Older Men (PERSONAL)

Primary Purpose

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tamsulosin
Placebo
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Urology patient at UCSF
  • Must own Android or iPhone smartphone, tablet, or computer
  • Taking tamsulosin for urinary-related symptoms
  • Able to speak and read English
  • Male 55-80 years old of age at telephone screening.
  • Written informed consent (and assent when applicable) obtained from subject or subject' s legal representative and ability for subject to comply with the requirements of the study.
  • Willing to receive electronic PERSONAL daily intake surveys for 3 months
  • Willing to self-report urinary symptom or medication side effect data at specified frequency.
  • Have home WiFi access.
  • Patients with h/o prostate cancer may be enrolled but is not required
  • Patients with h/o kidney stones may be enrolled but is not required

Exclusion Criteria:

  • Taking tamsulosin for <12 months.
  • International Prostate Symptom Score <5 or >25
  • Current participation in any other mobile app-based clinical study.
  • Planning to relocate from area within the study duration.
  • Impaired vision that could limit the use of the mobile apps (participant-reported)

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tamsulosin 0.4 mg or 0.8 mg, Then Placebo

Placebo, Then Tamsulosin 0.4 mg or 0.8 mg

Arm Description

Participants first received Tamsulosin 0.4 mg or 0.8 mg taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks. After a washout period of 1 week, the participants then received Placebo tablet taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks.

Participants first received Placebo tablet taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks. After a washout period of 1 week, the participants then received Tamsulosin 0.4 mg or 0.8 mg taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks.

Outcomes

Primary Outcome Measures

Change in Adapted International Prostate Symptom Score (IPSS)
Lower urinary tract symptoms will be measured using the adapted IPSS (recall period changed from 1 month to 24 hours). The score ranges from 0-35, with higher scores indicating more severe symptoms.

Secondary Outcome Measures

Medication side effect
Participants were asked to rate the presence and severity of common tamsulosin side effects

Full Information

First Posted
June 8, 2022
Last Updated
June 8, 2022
Sponsor
University of California, San Francisco
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05415748
Brief Title
Deprescribing Tamsulosin in Older Men
Acronym
PERSONAL
Official Title
PlacEbo-controlled, Randomized, Patient-Selected Outcomes N-of-1 triALs (PERSONAL-pilot): Alpha-blockers for Lower Urinary Tract Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 18, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a pilot 12-week randomized, placebo-controlled N-of-1 deprescribing trial among older men receiving chronic tamsulosin therapy for lower urinary tract symptoms attributed to benign prostatic hyperplasia.
Detailed Description
The investigators will instruct participants to monitor and record their daily urinary symptoms and medication side effects through Redcap surveys, accessible via smartphone. Medication adherence, global urinary satisfaction questions, and health-related quality of life will be assessed as baseline and at the end of the study. Monitoring frequency: Participants will monitor their symptoms every day using the PERSONAL-pilot study Redcap surveys. If the investigators notice a subject has been unresponsive to daily symptom monitoring, the investigators will reach out to the subject and offer any help we can provide. The investigators first attempt will be in the form of an email, sent to the email address provided to send patients the surveys. If the investigators do not receive a response, the investigators will follow up with a phone call to offer any help or guidance. Email template and telephone script provided in other study documents of the application. N-of-1 Trial Procedures: Participants will start with a 1-week open label period where participants will use the PERSONAL Redcap surveys to track daily symptoms and side effects while not taking their tamsulosin or any study pills. Based on the pharmacokinetics and expected timeframe of symptomatic relief from tamsulosin (half-life=14 to 15 hours; steady state by the 5th day of daily dosing), all N-of-1 trials will have a duration of 11 weeks during which participants will complete 2 cycles consisting of a pair of 2-week treatment periods (taking tamsulosin or placebo) separated by 1 week of wash-out on placebo. The order of treatment periods within a cycle will be random (e.g. ABAB, BABA, ABBA, or BAAB) according to pre-filled bubble packs given to participants during their orientation visit. Participants will receive a placebo during wash-out periods between treatment periods and cycles, but the participants will be unaware of the order or duration of treatment periods or cycles to prevent self-correlating symptoms to specific treatments. The PERSONAL Redcap will present participants with a daily questionnaire, accessible via smartphone, to track their lower urinary tract symptoms and medication side effects. All participants will also be presented a global urinary symptom bother question. At the end of each week, participants will receive additional medication adherence and treatment satisfaction questionnaires administered via the PERSONAL app as well as motivational messages summarizing their progress in the trial. Participants will view a graphical representation of their responses summarized in chronological order for the prior day, week, or month. To maximize adherence to daily questionnaires, participants will be contacted via email or phone if they have completed fewer than 4 daily questionnaires in any week during their N-of-1 trial. At the end of the study, the participants will complete an end of-study questionnaire and a 10-30 min. interview with staff member with formal qualitative research training. Then, PERSONAL staff will review N-of-1 trial results with the participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin 0.4 mg or 0.8 mg, Then Placebo
Arm Type
Experimental
Arm Description
Participants first received Tamsulosin 0.4 mg or 0.8 mg taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks. After a washout period of 1 week, the participants then received Placebo tablet taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks.
Arm Title
Placebo, Then Tamsulosin 0.4 mg or 0.8 mg
Arm Type
Experimental
Arm Description
Participants first received Placebo tablet taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks. After a washout period of 1 week, the participants then received Tamsulosin 0.4 mg or 0.8 mg taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Flomax
Intervention Description
Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks
Primary Outcome Measure Information:
Title
Change in Adapted International Prostate Symptom Score (IPSS)
Description
Lower urinary tract symptoms will be measured using the adapted IPSS (recall period changed from 1 month to 24 hours). The score ranges from 0-35, with higher scores indicating more severe symptoms.
Time Frame
Every day for 12 weeks
Secondary Outcome Measure Information:
Title
Medication side effect
Description
Participants were asked to rate the presence and severity of common tamsulosin side effects
Time Frame
Daily for 12 weeks
Other Pre-specified Outcome Measures:
Title
Urinary bother
Description
Participants are asked how they would feel if they were to spend the rest of their life with their urinary condition as it is now.
Time Frame
Baseline and 12-week follow-up
Title
PROMIS 29 v2.0
Description
The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain.
Time Frame
Baseline and 12-week follow-up
Title
Voils Medication Adherence
Description
Participants were asked several questions regarding the extent of medication nonadherence and the reasons for medication nonadherence.
Time Frame
Baseline and 12-week follow-up
Title
Post-Study System Usability Questionnaire
Description
Participants were asked their perceived satisfaction with the usability of the PERSONAL app.
Time Frame
Baseline and 12-week follow-up
Title
Revised Patients' Attitudes Towards Deprescribing (rPATD) Questionnaire
Description
Participants were asked several questions regarding their beliefs and attitudes towards deprescribing.
Time Frame
Baseline and 12-week follow-up
Title
Perceived change in urinary status
Description
Participants were asked if they felt that their urinary symptoms were unchanged, improved, or worsened
Time Frame
Baseline and 12-week follow-up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Urology patient at UCSF Must own Android or iPhone smartphone, tablet, or computer Taking tamsulosin for urinary-related symptoms Able to speak and read English Male 55-80 years old of age at telephone screening. Written informed consent (and assent when applicable) obtained from subject or subject' s legal representative and ability for subject to comply with the requirements of the study. Willing to receive electronic PERSONAL daily intake surveys for 3 months Willing to self-report urinary symptom or medication side effect data at specified frequency. Have home WiFi access. Patients with h/o prostate cancer may be enrolled but is not required Patients with h/o kidney stones may be enrolled but is not required Exclusion Criteria: Taking tamsulosin for <12 months. International Prostate Symptom Score <5 or >25 Current participation in any other mobile app-based clinical study. Planning to relocate from area within the study duration. Impaired vision that could limit the use of the mobile apps (participant-reported)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjmain N Breyer, MD, MAS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Deprescribing Tamsulosin in Older Men

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