The ProVerum First in Man PROVE Study

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: The ProVee Urethral Expander System

• Registration Number: NCT03972371
• Lead Sponsor: ProVerum Medical

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-13
• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Primary Completion: 2021-12-01
• Status Verified: 2023-11
• Study Completion: 2023-11-27
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	The ProVee Urethral Expander System	The ProVee Urethral Expander is implanted into the prostatic urethra to treat BPH symptoms

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
Rate of complications e.g. pain, difficulty with urination, related to the implant throughout the follow-up period of 2 years	2 years

Trial Locations

Locations (1)

The Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia