Our Research

Prostacare has undertaken two clinical studies to understand the safety and efficacy of water electrolysis for the treatment of BPH.

	Feasibility of Prostacare System in BPH Subjects	Safety and Efficacy Study
Objectives	Optimise treatment parameters Obtain preliminary safety and efficacy data Assess treatment tolerability	Demonstrate that BPH Symptoms as measures by IPSS are relieved after ProstaFix Treatment Demonstrate safety of the ProstaFix device
Subjects	16 BPH Patients	49 BPH Patients
Method	Treat BPH with the Prostacare System and follow up to 6 months	Treat BPH patients with the ProstaFix System and follow up to 24 months
Findings	Optimal treatment settings were observed for pivotal investigation Symptomatic relief (38% IPSS reduction) at 1-week post-treatment to study end Treatment was well tolerated with a topical gel only (no general anaesthesia). No serious side effects were observed.	BPH Symptoms were relieved at 1 week through to 12 months, as measures by the IPSS. Three (3) subjects experienced a total of four (4) SAEs (4/79, 5.1%) throughout the duration of the study. All SAEs were reported as not related to the procedure and/or the device.

Highlights of Prostacare’s research include:

Minimal Pain
Minimal Side Effects
Fast Acting and Durable
Convenient and Accessible

Excellent Tolerability without General Anaesthesia

The mean VAS score after placement of the device was 3.4. This was the most painful portion of the treatment for most subjects. At the beginning of the treatment, as measured 5 minutes into treatment, the mean VAS stabilized at 3.2, suggesting the electrolysis portion of the treatment did not increase subject discomfort. This level of pain is maintained throughout the treatment.

Overall, throughout the duration of procedure, the average pain level does not exceed a 5, which would be considered moderate pain; this suggests that this treatment is very well tolerated by the participants.

A Safe Alternative to Current Therapies

There were no reported cases of Device or procedure related Serious Adverse Events at 3 months.

That includes:

100% preservation of erections
100% preservation of continence
100% preservation of ejaculation

Lasting Relief in Days

The overall BPH symptom at baseline is “severe” with a mean IPSS of 21.7. At 1-week follow-up visit, there is a 4.9 (20.5%) IPSS score point decrease from baseline; this shows an overall BPH symptom change from “severe” to “moderate” within the first week of treatment. At 3-month follow-up visit subjects continued to experience improvement with a mean IPSS score change of 9.5 (43.9%) points compared to baseline.

Fast Treatment Time and Affordable Care

Treatment time is less than 30 minutes and patients can go home on the same day.

The treatment can be performed in the doctor's office, reducing costs to patients and practices.

Opportunities to Participate

You may be eligible to participate in one of Prostacare’s upcoming BPH studies.
To learn more or to register your interest: Complete form