Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT02026908
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment.
* Ability to understand and the willingness to sign a written informed consent
* Prostate volumes 40 - 200 gm. May include 30-39 gm if the subject has a long history of ineffective response to combination medical treatments (alpha-blocker and a 5-alpha reductase inhibitor) for at least 6 months
* Men ≥ 45 years of age
* IPSS symptom score \> 13 and IPSS bother score \> 2
* Peak flow rate Qmax≤ 12 with voided volume ≥125 cc
Exclusion Criteria:
* History of prostate or bladder cancer, pelvic radiation, untreated bladder stones,
* On alpha-blockers within the past 2 weeks unless on a stable dose of medication, with a stable urination pattern for 2 weeks prior to enrollment, and the willingness to stay on the same dose for the duration of the study, or until stopping criteria is met at the 12 month f/u visit, and or/part of a trial without catheter (TWOC) and patient is currently in Acute Urinary Retention (AUR)
* On 5-alpha reductase inhibitors within the past 6 months unless on a stable dose of medication with a stable urination pattern for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study or until stopping criteria is met at the 12 month f/u visit .
* On phenylephrine, pseudoephedrine, imipramine, an anticholinergic or cholinergic medication within the past 2 weeks unless on a stable dose of medication with a stable urination pattern for 2 weeks prior to enrollment and the willingness to stay on the same dose for the duration of the study or until stopping criteria is met at the 12 month f/u visit .
* On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months unless on stable dose of medication for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study.
* Daily use of a pad or device for incontinence required.
* Urethral strictures, renal insufficiency (i.e. creatinine \> 1.8)
* Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
* Neurogenic bladder, Hypotonic Bladder
* Prior treatment for urinary incontinence
* Penile prosthesis.
* Artificial urinary sphincter.
* Documented bacterial prostatitis within the past year.
* Active urinary tract infection (UTI) unless in case of regular catheter dependence and thought to represent colonization.
* History of chronic prostatitis within the last 1 year
* Known bleeding disorders (e.g. von willebrand disease (VWD))
* History of urethral strictures/bladder neck closure (BNC)
* Prior prostate procedures (e.g. Transurethral microwave therapy (TUMT), transurethral needle ablation of the prostate (TUNA), water-induced thermotherapy (WIT), transurethral resection of the prostate (TURP), photo-vaporization of the prostate (PVP))
* Prior treatment for overactive bladder (e.g. intravesical botox)
* Prostate Specific Antigen (PSA) \> 4.0, \< 10.0 unless documented negative prostate biopsy within past 2 years and is not thought to harbor prostatic malignancy in the clinical opinion of the primary or co-investigator.
* Enrolled in another treatment trial for any disease within the past 30 days
* Declines or unable to provide informed consent
* Condition precluding catheter-based intervention (ie occluded vessel, severe atheromatous disease)
* Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, uncontrolled diabetes, cardiac arrhythmias, cardiac disease including congestive heart failure, significant respiratory disease, or known immunosuppression.
* A history of rectal malignancy
* Prior surgical prostate intervention
* Interest in future fertility
* Allergy to Iodinated contrast agents not responsive to steroid premedication regimen
* Contraindication to Conscious sedation
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT02026908
Study Brief:
Protocol Section:
NCT02026908