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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT02248467
Eligibility Criteria:
Inclusion Criteria:
* Male subjects
* Age between 25 and 65 years
* Obese men, candidate to a bariatric surgery (body mass index (BMI) is ≥40 kg/m2, or if their BMI is \>35 kg/m2 and they suffer from other life-threatening co-morbidities such as Type 2 Diabetes Mellitus, hypertension and cardiovascular disease)
* Men with LUTS defined by: IPSS ≥ 8.
* Evidence of a personally signed and dated informed consent
Exclusion Criteria:
* Bladder failure or Neurogenic bladder
* LUT disease (Urethral stenosis, diverticula)
* LUT surgery (Prostatectomy, bladder neck surgery, TURP)
* Severe systemic disease
* Previous or concomitant neoplasm
* Unable to consistently and accurately complete the protocol
* Abuse alcohol or drugs
* Psychiatric disease
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT02248467
Study Brief:
Protocol Section:
NCT02248467