WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia

BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms Clinical Trial

— WATER III  

Official title:

WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80-180ml) in Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801381
• Other study ID #: URO-202001
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2020
• Est. completion date: December 2028

Study information

• Verified date: May 2023
• Source: University of Bonn
• Contact: Johannes Stein, Dr. med.
• Phone: 0049228/28714184
• Email: johannes.stein[@]ukbonn.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparative analysis of efficacy and safety of Aquablation (AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA) and transurethral laser enucleation as surgical therapy for benign prostatic hyperplasia with large prostates (80-180ml).

Description:

Prospective randomized and non-randomized cohort, two-arm multicenter trial two arm multicenter trial to evaluate the efficacy and safety of Aquablation (AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA) compared to transurethral laser enucleation - the current reference standard of minimal invasive therapy for benign prostatic hyperplasia in large prostates (80-180ml).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2028
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age: 45 - 80 years

2. International Prostate Symptom Score (IPSS) = 8

3. Prostate size (measurement by transrectal ultrasound): 80 - 180 mL

4. Subject has diagnosis of LUTS (Lower urinary tract symptoms) due to BPH (Benign Prostatic Hyperplasia)

5. Patient is mentally capable and willing to sign a study-specific consent form

6. Subjects with the ability to follow study instructions and likely to attend and complete all required visits

7. Written informed consent

Exclusion Criteria:

1. Body mass index = 42

2. Suspected or history of prostate cancer

3. Suspected or history of bladder cancer

4. Bladder stone

5. Indwelling catheter for more than 3 months before baseline

6. Active urinary tract infection

7. History of urethral stricture or bladder neck stenosis

8. Damage of the external urethral sphincter

9. Previous prostate surgery or history of lower urinary tract surgery (e.g. urinary diversion, artificial sphincter or penile prosthesis)

10. Use of anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except ASS 100mg/d).

11. Contraindications for general and spinal anaesthesia

12. The investigator considers a pre-existing condition or the subject's life circumstances to be problematic for the conduct of the study and the completion of the follow-up investigations

13. Subject is unwilling to accept a blood transfusion if required

14. Subject is not able to give consent

15. Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial

16. Simultaneously participation in another clinical trial in the field of urology

17. Known or persistent abuse of medication, drugs or alcohol

Related Conditions & MeSH terms

• BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Procedure:
• Aquablation therapy
Aquablation is carried out with the AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA
• Transurethral laser enucleation
Transurethral laser enucleation is performed according to the standard established at the respective test center. Included laser techniques: Holmium laser (HoLEP) and Thulium laser (ThuLEP).

Locations

Country	Name	City	State
Germany	Department of Urology, Augusta-Kranken-Anstalt, Bochum Mitte	Bochum	NRW
Germany	Department of Urology, University of Bonn	Bonn	NRW
Germany	Klinik für Urologie, Universitätsklinikum Freiburg	Freiburg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Bonn	PROCEPT BioRobotics

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint	Primary efficacy endpoint is defined as IPSS (International Prostate Symptom Score) change	3 months after index procedure
Primary	Primary Safety Endpoint	Primary safety endpoint is defined as the occurrence of an Adverse Event rated by the investigator as related or unrelated to the study procedure, classified as Clavien Dindo grade 2 or higher or any grade 1 event resulting in persistent disability, such as ejaculatory or erectile dysfunction or incontinence, as evidenced through 3 months after treatment.	Through 3 months after index procedure
Secondary	Change in IPSS	Change in IPSS (International Prostate Symptom Score)	1,6,12,24,36,48 and 60 months after index procedure
Secondary	Change in IIEF 5/SHIM	Change in IIEF5/SHIM (International Index of Erectile Function)	3,6,12,24,36,48 and 60 months after index procedure
Secondary	Change in MSHQ-EjD-SF	Change in MSHQ-EjD-SF (Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form)	3,6,12,24,36,48 and 60 months after index procedure
Secondary	Change in Dysuria Questionnaire	Change in Dysuria Questionnaire	1,3,6,12,24,36,48 and 60 months after index procedure
Secondary	Change in ICIQ-UI-SF	Change in ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form)	1,3,6,12, 24,36,48 and 60 months after index procedure
Secondary	Post void residual urine	Reduction of Post void residual urine	day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
Secondary	Qmax, Uroflowmetry	Changes of maximum flow rate (Qmax) measured by Uroflowmetry	day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
Secondary	Prostate volume reduction	Prostate volume reduction	comparison of Visit 5 (3 months) and visit 1 (baseline)
Secondary	Number of re-interventions	Number of re-interventions defined as need for additional tissue resection following the index procedure due to BPH.	Through 60 months after index procedure