Last updated: January 7, 2021
Sponsor: Dr. med. Gautier Müllhaupt
Overall Status: Active - Recruiting
Phase
N/A
Condition
Prostate Disorders
Treatment
N/AClinical Study ID
NCT04560907
CantonalHSG
Ages > 45 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Men ≥45 years of age
- Patient must be a candidate for HoLEP
- Refractory to medical therapy or patient is not willing to consider (further)medical treatment
- Patient has a prostate size of at least 50 ml and not more than 150ml, measuredby transrectal ultrasound (TRUS)
- IPSS ≥12
- QoL≥3
- Qmax ≤ 15 ml/s with a minimum voided volume ≥ 125 ml or patient in urinaryretention
- Written informed consent
Exclusion
Exclusion Criteria:
- Neurogenic lower urinary tract dysfunction
- Urethral stenosis
- Preinterventionally proven adenocarcinoma of the prostate
- Nickel allergy
- Not able to complete questionnaires due to cognitive or thought disorders
- Language skills insufficient for informed consent and / or completion ofquestionnaires
Study Design
Total Participants: 120
Study Start date:
January 05, 2021
Estimated Completion Date:
November 30, 2027
Connect with a study center
Cantonal Hospital St. Gallen
Saint Gallen, 9010
SwitzerlandActive - Recruiting
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