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
This trial does not accept healthy volunteersQualifiers
• 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
Design model
Single group
Treatments tested in this trial
INTUPRO ionic fluid
DeviceUnder TRUS imaging, a fixed dose of the ablative agent will be administered to patients by the physician via needle. Each patient will receive a total of 4-10 mL ionic fluid , administered as two separate 2-5 mL injections into each side of the prostatic urethra.
Treatment groups
31 Participants
are divided into 1 treatment groupGroup A: Intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Urinary Symptoms (IPSS Score)
The change in the International Prostate Symptom Score (IPSS) from baseline will be evaluated after treatment. IPSS scores recorded at the screening visit will be compared with scores obtained at the 1-month and 3-month follow-up visits. A reduction in the IPSS score at 1 month and 3 months compared with baseline will be considered a primary outcome measure.
Time frame
3 months2
Procedure-Related and Post-Procedure Complications
Complications related to the procedure and the postoperative period will be assessed at 1 day, 1 month, and 3 months after treatment. The following complications will be specifically monitored: * Urinary retention * Urinary tract infection, suggested by a positive urine culture * Urosepsis * Blood in the urine (hematuria) * Perineal hematoma
Time frame
3 monthsSecondary outcomes
1
Procedure-Related Pain (Wong-Baker Pain Scale)
Pain related to the procedure will be assessed using the Wong-Baker Pain Scale on the day of treatment (Day 1), and at the 1-month and 3-month follow-up visits. Pain scores at follow-up visits will be compared with the pain level recorded on the day of the procedure.
Time frame
3 months2
Urinary Incontinence Symptoms (ICIQ-UI)
Changes in urinary incontinence symptoms will be evaluated using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). Scores will be recorded at baseline, 1 month, and 3 months after treatment, and follow-up scores will be compared with baseline values.
Time frame
3 months3
Sexual Function (IIEF Score)
Changes in erectile function will be assessed using the International Index of Erectile Function (IIEF). Scores will be collected at baseline, 1 month, and 3 months, and compared with baseline measurements.
Time frame
3 months4
Retrograde Ejaculation
The proportion of patients reporting retrograde ejaculation after the procedure will be recorded at the 1-month and 3-month follow-up visits.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov