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:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT01931605
Eligibility Criteria:
Inclusion Criteria:
* Patients with a urinary retention due to obstructive benign prostatic hyperplasia (BPH) confirmed by endoscopy,
* Patients aged 50-85 years,
* Patients with indwelling urinary catheter for at least 1 month,
* Patients with at least one failure of a trial without catheter despite alpha-blocker treatment for at least 72 hours,
* Patients informed about alternative treatment (transurethral resection of the prostate, laser prostatectomy, prostatic adenomectomy),
* Patients signed an informed consent form.
Exclusion Criteria:
* Prostate cancer (evaluated by PSA, physical examination, in all patients and by prostatic biopsy in suspicious cases).
* History of relevant neurological disease (e.g. multiple sclerosis, spinal cord injury, parkinson's disease).
* Patients who have on urodynamic investigation evidence of an atonic bladder.
* Urethral stricture
* Chronic persistent local pathology that may cause urinary symptoms (e.g. interstitial cystitis, tumor, bladder stone).
* Renal insufficiency stade 3 or 4 (creatinine clearance \< 35 mL/min)
* Any allergy or contraindication to ciprofloxacin or drugs used in this protocole (xylocaine, Atarax, paracetamol, and nonsteroidal anti-inflammatory drug)
* Any allergy to intravenous contrast agent or iodine
* Thyrotoxicosis
* Concomitant use of tizanidine
* Patients participating to another research protocol
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT01931605
Study Brief:
Protocol Section:
NCT01931605