Aquablation Pilot Study for the treatment of Benign Prostatic Hyperplasia.

Single-arm prospective, interventional pilot study to evaluate the safety, feasibility and efficacy of the PROCEPT AquablationTM System (PAS) device for the treatment of Benign Prostatic Hyperplasia (BPH)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000167763

Acronym

APS – Aquablation Pilot Study

Enrollment

Registered

2013-02-12

Start date

2013-01-18

Completion date

2014-07-21

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The hypothesis is that the use of Aquablation will provide a clinically effective cutting and coagulation action on prostatic tissue without the need for thermal energy thereby reducing perioperative complications such as bleeding, catheterisation, shorter recovery time and dysuria. It is hypothesised that the more effective operative technique will provide an earlier improvement in patients' quality of life as evidenced by a reduction in symptoms, no deterioration of erectile dysfunction and improvements in peak urinary flow rate and post void residual volume.

Interventions

The PROCEPT Aquablation(TM) System (PAS) is intended to remove prostate tissue as a treatment for Benign Prostatic Hyperplasia (BPH). The transurethral procedure involves the delivery of a high pressure water jet that cuts through tissue without thermal injury. A dedicated surgical laser (the AquabeamTM), delivered through a column of water coagulates bleeding tissues. The approximate duration of this procedure is 60 minutes.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

Male, Age > 50 years with BPH and history of inadequate response to medical therapy.

Exclusion criteria

Large median lobe, urethral length >6cm, prostates >80g, prostate cancer, current urological conditions affecting procedural outcomes, previous prostate surgery, significant renal impairment, listed concomitant medications and listed uncontrolled co-morbidities.

Outcome results