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Recruiting
NCT05714488
Evaluation of the "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction
Conditions: Urinary Retention
Sex: Male
Ages: 50 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 95
Sponsor: Blue Halo Biomedical, LLC
Location: United States
Summary
The Investigators will study 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.
Eligibility Criteria
Inclusion Criteria:Male subjects > 50 years of ageAble to provide consentParticipants in urinary retention with post void residual > 350 ccUrinary retention is due to BPH with a prostate volume > 50cc or a prostatic urethral length of 5+ cmSubjects with a PSA > 4 ng/ml and a PSA density of 0.1 or lessSubjects on alpha- blocking drugs or 5-alpha-reductase inhibitor drugs may be includedExclusion CriteriaInability to undergo bladder catheterization ( i.e. urethral stricture)Presence of gross hematuriaLack of cognitive ability to give consent or keep appointmentsHistory of Prostate CancerSubject 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 enrollmentA subject with a prostate nodule will require biopsy to exclude cancer diagnosisSubject with a PSA > 10 ng/mlSubject taking LHRH analogs or anti-androgen drugs
Source: ClinicalTrials.gov (NCT05714488). StuddyBuddy aggregates publicly available trial information.