Evaluation of a new catheter for men with urinary retention due to prostate issues
Study: A Prospective Evaluation of the Blue Halo BioMedical, LLC "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction
This study tests a new catheter to see if it can help men over 50 with urinary retention from prostate issues drain their bladders better and possibly return to normal urination.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Blue Halo Biomedical, LLC Academic / other |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT05714488 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the Blue Halo Coil Catheter in adult males suffering from urinary retention caused by benign prostatic hyperplasia (BPH). Participants will be men over 50 years old who have been dependent on catheters or have a high post void residual volume. The catheter is designed for temporary use, allowing for bladder drainage and the potential for patients to return to normal voiding. The study aims to reduce post void residual volumes to less than 75 cc.
Who should consider this trial
Good fit: Ideal candidates are men over 50 with urinary retention due to BPH and a post void residual greater than 350 cc.
Not a fit: Patients with urethral strictures, prostate cancer, or those unable to undergo catheterization will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve the quality of life for men with urinary retention by enabling them to void normally.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving urinary retention management in men with BPH.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 3 other locations
- The University of Alabama-Birmingham — Birmingham, Alabama, United States (Recruiting)
- Mayo Clinic Arizona — Phoenix, Arizona, United States (Recruiting)
- Florida Urology Partners — Brandon, Florida, United States (Recruiting)
- Vero Urology Center — Vero Beach, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Gameel B Hodge, Md
- Email: bhodge@bluehalobiomedical.com
- Phone: 407-492-1683
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.