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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT01534793
Eligibility Criteria:
Inclusion Criteria:
1. Male patients over 50
2. Classification of risk according to the American Society of Anesthesiologists (ASA) score: score 1, 2 or 3
3. Protocol accepted by patient (signed informed consent)
4. Patient presenting low urinary tract symptoms due to benign prostatic hyperplasia, since at least 3 months, with indication of surgical relief of bladder outlet obstruction , with International prostate symptom score (I-PSS)≥ 12 and a bother score ≥ 3, or full bladder retention, drained by a catheter or suprapubic catheter
5. Patient with maximum urinary flow rate ≤ 12mL/s for a voiding volume ≥ 125mLat uroflowmetry, for patients who are not drained
6. Prostate weight between 40 and 80 grams
7. Post void residual volume ≤ 300cc, for patients who are not drained
8. Normal renal function
9. Non suspect digital rectal examination
10. PSA value et blood test £ 4 ng/ml, or negative prostatic biopsies if PSA comprised between 4 and 10 ng/ml for patients with age \< 75 and life expectancy \> 10 years
11. Patient under oral anticoagulation therapy if a therapeutic switch is possible and validated by both the anaesthesiologist and the prescription of the anticoagulation therapy
12. Patient under under antiplatelet agents if this treatment can be interrupted without replacement therapy 5 days prior to surgery without any increased risk for the patient safety
13. Patient gave informed consent and is not opposed to the use of the data collected during the study for research purpose
14. Patient treated by BPH drugs if the duration and type are known, and if the treatment has been stopped before the intervention (one week before surgery for plants and alpha-blockers, one week for 5-alpha reductase inhibitors)
15. Patients has valid health insurance/coverage.
Exclusion Criteria:
1. Patients with unstable known cardiac or pulmonary disease
2. Patients with severe myasthenia, multiple sclerosis, Parkinson disease with known bladder or urinary sphincter dysfunction.
3. Patient with history of severe pelvic injury having caused severe external urinary sphincter damage.
4. Patient with active urinary tract infection
5. Patient with urinary catheter or a suprapubic catheter for a reason other than acute urinary retention due to benign prostatic hyperplasia or experiencing no need to urinate after an event filling than 300cc
6. Patient with neurogenic disease of the urinary tract
7. Patient with known or suspected malignant lesion of the bladder or the prostate
8. Patient with history of previous prostatic surgery
9. Patient with history of bladder stone, major hematuria, urethral stricture, bladder neck stenosis, bladder disease or diabetes with bladder impairment
10. Patient with a prosthesis or material in the region potentially affected by the surgical procedure.
11. Patient with ano-rectal disease
12. Cases where the surgical indication is decided in an emergency context
13. Patient with predictable incomplete follow-up
14. Patient with coagulation disease or abnormalities not covered by the drugs belonging to the categories cited in inclusion criteria 11 and 12
15. All patient condition that the investigator considers as an exclusion criterion
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT01534793
Study Brief:
Protocol Section:
NCT01534793