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:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT01810068
Eligibility Criteria:
Inclusion Criteria:
1. Lower urinary symptoms (LUTS) secondary to bladder outlet obstruction from BPH.
2. Failed medical treatment of BPH.
3. International prostate symptom score (IPSS) \>9.
4. Peak urinary flow rate (Qmax) \<10 ml/sec.
5. Patients in retention secondary to BPH.
6. Total prostate size not less than 30 gm by TRUS (transrectal ultrasound)
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Exclusion Criteria:
1. Patient who have a neurological disorder as neurogenic bladder, cerebrovascular stroke or Parkinson disease.
2. Non BPH causes of LUTS as cystitis.
3. Infravesical causes of LUTS other than BPH as urethral stricture.
4. Presence of active bladder cancer (within the last 2 years).
5. Known cancer prostate patients on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
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Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT01810068
Study Brief:
Protocol Section:
NCT01810068