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Investigating the Adjunctive Use of Mirabegron in the Early Post-Rezum Procedure Period

ConditionBenign Prostate Hypertrophy(BPH)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age50+
SponsorUniversity of Manitoba

About this trial

The investigators propose conducting a randomized controlled trial at the Men's Health Clinic to evaluate whether patients who start and continue mirabegron postoperatively after undergoing Rezum therapy experience enhanced patient-reported outcomes, improved quality of life (QoL), and comparable rates of adverse events. There are no predicted adverse events of this study. There are no identified potential harms of this study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age >50, symptomatic LUTS with IPSS ≥ 10

prostate volume 30-80cc on any imaging modality

Qmax between 5 and 15ml/s with minimum voided volume of 125cc

frequency ≥ 8 voids/day.

Disqualifiers

PVR greater than 300ml

active UTI within past week

previous surgical intervention for BPH

documented urethral stricture disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Beta-3 agonists (Mirabegron/Myrbetriq)

    Drug

    Patients in this arm will receive the medication in pill form following their procedure

  • Placebo group post rezum

    Other intervention

    Patients in this arm will receive the placebo pill following their procedure.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Mirabegron post procedureExperimental treatment 1 intervention
Group B: Placebo pill post rezumSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in symptom scores

Change in the following symptoms scores IPSS-QOL (higher scores indicate worser outcomes)

Time frame
Symptom scores will be taken pre-op at time of consultation and at 1, 2 and 4 week follow-up
2

Change in symptom scores

Change in OABSS symptom scores. (higher scores indicate worse outcomes)

Time frame
Symptom scores will be taken pre-op at time of consultation and at 1, 2 and 4 week follow-up

Secondary outcomes

1

Rate of successful catheter removal

Rates of successful trial of voids(TOV) post-op will be captured. If the catheter is removed it is a succesful TOV, if it is not it is considered a failed TOV.

Time frame
Will be measured at the scheduled trial of void either 1 week or 2 weeks post-op
2

Adverse events

Adverse events will be captured and recorded post-op.

Time frame
Possible adverse will be captured at time of consultation pre-op and at 1, 2 and 4 week follow-ups.
3

rate of Qmax improvement

Uroflow parameter

Time frame
Uroflow parameters will be captured at time of consultation pre-op and the 4 week follow-up post-op.
4

rates of post void residual

Uroflow test

Time frame
Uroflow parameters will be captured at time of consultation pre-op and the 4 week follow-up post-op.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Manitoba

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: