INTUPRO in the Treatment of Benign Prostatic Hyperplasia-Related Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45+
SponsorinTumo Therapeutics, Inc.
About this trial
The goal of this clinical trial is to determine whether INTUPRO can improve the quality of life in patients with Benign Prostate Hyperplasia (BPH).
The main questions it aims to answer are:
Can INTUPRO treatment lead to the removal of the Foley catheter? Can INTUPRO treatment improve urinary flow? Can INTUPRO treatment lower or minimize waking during sleep to urinate? Can INTUPRO reduce urinary hesitancy, urgency and frequency?
Participants will:
Receive INTUPRO treatment on Day 1. Visit at Day 30 and Day 90 for checkups, tests and Prostate MRI.
Eligibility criteria
Qualifiers
• Male patient aged 45 years or older
Prostate volume greater than 30 grams
An International Prostate Symptom Score (IPSS) of 12 or higher
Presence of obstructive urinary symptoms, such as difficulty starting urination, leakage of urine after voiding, or a feeling of incomplete bladder emptying.
Disqualifiers
Urethral stricture
Bladder stones
Prostate volume 120 grams or greater
Presence of a prostate median lobe
Trial design
Treatments tested in this trial
- INTUPRO ionic fluid
Treatment groups
31 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov