Phase
Condition
Enuresis
Interstitial Cystitis
Prostate Disorders
Treatment
Aquablation therapy
Transurethral laser enucleation
Clinical Study ID
Ages 45-80 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age: 45 - 80 years
International Prostate Symptom Score (IPSS) ≥ 8
Prostate size (measurement by transrectal ultrasound): 80 - 180 mL
Subject has diagnosis of LUTS (Lower urinary tract symptoms) due to BPH (BenignProstatic Hyperplasia)
Patient is mentally capable and willing to sign a study-specific consent form
Subjects with the ability to follow study instructions and likely to attend andcomplete all required visits
Written informed consent
Exclusion
Exclusion Criteria:
Body mass index ≥ 42
Suspected or history of prostate cancer
Suspected or history of bladder cancer
Bladder stone
Indwelling catheter for more than 3 months before baseline
Active urinary tract infection
History of urethral stricture or bladder neck stenosis
Damage of the external urethral sphincter
Previous prostate surgery or history of lower urinary tract surgery (e.g. urinarydiversion, artificial sphincter or penile prosthesis)
Use of anticoagulants (if medication cannot be stopped before and after procedure)or known coagulopathy (except ASS 100mg/d).
Contraindications for general and spinal anaesthesia
The investigator considers a pre-existing condition or the subject's lifecircumstances to be problematic for the conduct of the study and the completion ofthe follow-up investigations
Subject is unwilling to accept a blood transfusion if required
Subject is not able to give consent
Subject without legal capacity who is unable to understand the nature, scope,significance and consequences of this clinical trial
Simultaneously participation in another clinical trial in the field of urology
Known or persistent abuse of medication, drugs or alcohol
Study Design
Study Description
Connect with a study center
Department of Urology, University Hospital Freiburg
Freiburg, Baden-Württemberg 79106
GermanySite Not Available
Klinik für Urologie, Universitätsklinikum Freiburg
Freiburg, Baden-Württemberg 79106
GermanyActive - Recruiting
Department of Urology, Augusta-Kranken-Anstalt, Bochum Mitte
Bochum, NRW 44791
GermanySite Not Available
Department of Urology, University Hospital Bonn
Bonn, NRW 53127
GermanySite Not Available
Department of Urology, University of Bonn
Bonn, NRW 53127
GermanyActive - Recruiting
Department of Urologie, Asklepios Westklinikum Hamburg
Hamburg, 22559
GermanySite Not Available
Frimley Health NHS Foundation Trust
London,
United KingdomSite Not Available
Guy's and St. Thomas' Hospital
London,
United KingdomSite Not Available
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