Benign Prostatic Hyperplasia
Conditions
Brief summary
A clinical evaluation to assess the safety and performance of the ProVeeTM Urethral Expander System, designed to alleviate the symptoms of Benign Prostatic Hyperplasia (BPH).
Interventions
DEVICEThe ProVee Urethral Expander System
The ProVee Urethral Expander System is supplied as a single use, sterile device and consists of a nitinol expander implant and custom implant delivery system. The delivery system is designed to allow the implant to be deployed under direct vision.
Sponsors
ProVerum Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, non-randomised, single centre, safety and feasibility study
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males ≥ 50 years of age * Moderate-to-severe symptomatic BPH * IPSS of \> 15 * Peak urinary flow rate (Qmax) of \<12 mL/s * Prostate volume of ≥ 30 and ≤80 cc * Prostatic urethral lengths ≥ 4cm
Exclusion criteria
* A prostatic urethral length of less than 4cm * A prostatic volume \<30cc or \>80cc * An obstructing intravesical prostatic median lobe * Urinary incontinence due to an incompetent external sphincter * Urethral pathologies that may prevent insertion of delivery system * A current symptomatic urinary tract infection * Current significant visible haematuria * Patients with known allergy to nickel or titanium * History of significant medical co-morbidity or prior surgery that may confound the results of the Study * Another medical condition that would pose an unacceptable patient risk * Known or suspected urological condition that may affected voiding function * Neurogenic bladder and/or sphincter abnormalities * Patients with cognitive disabilities unable to understand and give informed consent to the research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deployment of the Implant | Immediately after the implant deployment procedure | Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment endoscopy |
| Expansion of the Implant | Within 24 hours of the implant deployment procedure | Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complications e.g. difficulty with urination, related to the implant use peri-procedurally and in the immediate follow up period | Immediately after the implant deployment procedure, within 24 hours | — |
| Rate of complications e.g. pain, difficulty with urination, related to the implant throughout the follow-up period of 2 years | 2 years | — |
| Preliminary assessment of the effectiveness of the procedure in alleviating LUTS voiding symptoms | 2 years | Change in symptom score using the Improvement in International Prostate Symptom Score and Quality of Life score instrument within the 2 year follow up period |
| Preliminary assessment of the effectiveness of the procedure in improving urinary flow | 2 years | Change in Qmax measurement within the 2 year follow up period |
Countries
Australia
Outcome results
None listed