NCT02962674

Brief Summary

The purpose of this study is to evaluate the safety and performance of the ProstaCare System in relieving symptoms of urinary outflow obstruction secondary to benign prostatic hyperplasia.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 15, 2021

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

2.1 years

First QC Date

November 9, 2016

Results QC Date

August 3, 2021

Last Update Submit

October 13, 2021

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH

Outcome Measures

Primary Outcomes (2)

  • Mean International Prostate Symptom Score (IPSS) at 3 Months Follow-up Visit

    The primary effectiveness objective was to demonstrate that mean IPSS improvement (Δ IPSS) following treatment with the prostaFix System exceeded 6.5 points with 95% confidence 3 months after treatment. The International Prostate Symptom Score (IPSS) is a validated questionnaire used to assess baseline and post treatment BPH symptoms. It is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the subject to choose one out of six answers indicating increasing severity of that particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic): Mild (symptom score less than or equal to 7), Moderate (symptom score range 8-19) and Severe (symptom score range 20-35). Improvement in BPH symptoms is seen as a decrease in IPSS.

    3 months after treatment

  • Number of Participants With Serious Adverse Events (SAEs)

    The primary safety objective of this study was to estimate the proportion of subjects affected by serious adverse events (SAEs) associated with the use of the device. This objective was addressed through recording all adverse events (AEs) observed or reported during the course of the study.

    3 months after treatment

Secondary Outcomes (12)

  • Mean Change in QOL From Baseline

    Baseline and 3 months after treatment

  • Mean Change in Peak Flow Rate (Qmax) From Baseline

    Baseline and 3 months after treatment

  • Mean Change in Post Void Residual (PVR) From Baseline

    Baseline and 3 months after treatment

  • Mean Change in MSHQ-EjD Score From Baseline

    Baseline and 3 months after treatment

  • Change in IIEF Score From Baseline

    Baseline and 3 months after treatment

  • +7 more secondary outcomes

Study Arms (1)

Treatment

OTHER
Device: prostaFix System

Interventions

prostaFix SystemDEVICE
Treatment

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older with a diagnosis of BPH,
  • International Prostate Symptom Score (IPSS) of 12 or greater,
  • Prostate volume between 25 cm3 and 55 cm3,
  • Uroflow with peak flow rate (Qmax) no greater than 13 ml/sec with a corresponding voided volume of at least 100 ml and a post void residual (PVR) of 250 ml or less.
  • Prostate length, width and height must be at least 3.2 cm, 3.5 cm and 2.5 cm, respectively

You may not qualify if:

  • Obstruction due to an enlarged middle lobe, central gland or significant transverse asymmetry,
  • Active urinary tract infection at time of treatment,
  • Interest in maintaining fertility,
  • Past history of urologic surgery or minimally invasive treatment for BPH,
  • History of or current medical conditions contraindicating elective urological procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Urology Bay of Plenty (BOP)

Tauranga, 3112, New Zealand

Location

National University Hospital

Singapore, 119074, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Annegret Genger
Organization
seleon gmbh
Annegret.Genger@seleon.de
+49 175 934 91 83

Study Officials

  • Henry Ho Sun Sien, MD

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 11, 2016

Study Start

September 19, 2016

Primary Completion

October 30, 2018

Study Completion

November 20, 2020

Last Updated

October 15, 2021

Results First Posted

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)SG(2)