Deprescribing Tamsulosin in Older Men

Benign Prostatic Hyperplasia Clinical Trial

— PERSONAL  

Official title:

PlacEbo-controlled, Randomized, Patient-Selected Outcomes N-of-1 triALs (PERSONAL-pilot): Alpha-blockers for Lower Urinary Tract Symptoms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05415748
• Other study ID #: 19-28557
• Secondary ID: K12DK111028
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 18, 2021
• Est. completion date: June 2022

Study information

• Verified date: June 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• Tamsulosin
Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks
• Placebo
Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urinary bother	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.	Baseline and 12-week follow-up
Other	PROMIS 29 v2.0	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.	Baseline and 12-week follow-up
Other	Voils Medication Adherence	Participants were asked several questions regarding the extent of medication nonadherence and the reasons for medication nonadherence.	Baseline and 12-week follow-up
Other	Post-Study System Usability Questionnaire	Participants were asked their perceived satisfaction with the usability of the PERSONAL app.	Baseline and 12-week follow-up
Other	Revised Patients' Attitudes Towards Deprescribing (rPATD) Questionnaire	Participants were asked several questions regarding their beliefs and attitudes towards deprescribing.	Baseline and 12-week follow-up
Other	Perceived change in urinary status	Participants were asked if they felt that their urinary symptoms were unchanged, improved, or worsened	Baseline and 12-week follow-up
Primary	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.	Every day for 12 weeks
Secondary	Medication side effect	Participants were asked to rate the presence and severity of common tamsulosin side effects	Daily for 12 weeks