Clinical trial NCT05415748: Deprescribing Tamsulosin in Older Men
Official title: PlacEbo-controlled, Randomized, Patient-Selected Outcomes N-of-1 triALs (PERSONAL-pilot): Alpha-blockers for Lower Urinary Tract Symptoms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-06-13
Enrollment: 31
Sex: MALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Adapted International Prostate Symptom Score (IPSS)
timeFrame: Every day for 12 weeks
Secondary outcomes:
measure: Medication side effect
timeFrame: Daily for 12 weeks
Other outcomes:
measure: Urinary bother
timeFrame: Baseline and 12-week follow-up
measure: PROMIS 29 v2.0
timeFrame: Baseline and 12-week follow-up
measure: Voils Medication Adherence
timeFrame: Baseline and 12-week follow-up
measure: Post-Study System Usability Questionnaire
timeFrame: Baseline and 12-week follow-up
measure: Revised Patients' Attitudes Towards Deprescribing (rPATD) Questionnaire
timeFrame: Baseline and 12-week follow-up
measure: Perceived change in urinary status
timeFrame: Baseline and 12-week follow-up
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Benjmain N Breyer, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: