Evaluation of the Blue Halo Coil Catheter for Patients With Prostatic Obstruction

Overview

About this study

The purpose of this study is to investigate a device for men in urinary retention secondary to Benign Prostatic Hyperplasia, BPH ,who are catheter dependent or who have a Post Void Residual > 350cc. The hypothesis is that the device will allow these participants to return to volitional voiding with a Post Void Residual < 75 cc.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Male subjects > 50 years of age.
Able to provide consent.
Participants in urinary retention with post void residual > 350 cc.
Urinary retention is due to BPH with a prostate volume > 50cc or a prostatic urethral length of 5+ cm.
Subjects with a PSA > 4 ng/ml and a PSA density of 0.1 or less.
Subjects on alpha- blocking drugs or 5-alpha-reductase inhibitor drugs may be included.

Exclusion Criteria

Inability to undergo bladder catheterization (i.e., urethral stricture).
Presence of gross hematuria.
Lack of cognitive ability to give consent or keep appointments.
History of Prostate Cancer.
Subject with a PSA > 4 ng/ml and a PSA density of > 0.1 will require prostate biopsy to rule out prostate cancer in order to be considered for study enrollment.
A subject with a prostate nodule will require biopsy to exclude cancer diagnosis.
Subject with a PSA > 10 ng/ml.
Subject taking LHRH analogs or anti-androgen drugs.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/2/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Mitchell Humphreys, M.D.	Open for enrollment	Contact information: Debra Ryan CCRP (480) 342-1208 Ryan.Debra29@mayo.edu

Mayo Clinic Location

Status

Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitchell Humphreys, M.D.

Open for enrollment

Contact information:

Debra Ryan CCRP

(480) 342-1208

Ryan.Debra29@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials