Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER) (WATER)
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|ClinicalTrials.gov Identifier: NCT02505919|
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : April 8, 2020
Last Update Posted : April 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia (BPH)||Device: AQUABEAM System Procedure: Transurethral Resection of the Prostate (TURP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||All study subjects are blinded to the assigned treatment until study exit. One of the investigational site teams is blinded to the randomization assignment as well.|
|Official Title:||A Prospective Multicenter Randomized Blinded Study Comparing Aquablation of the Prostate With the AQUABEAM System and TURP for the Treatment of LUTS|
|Actual Study Start Date :||November 21, 2015|
|Actual Primary Completion Date :||July 14, 2017|
|Actual Study Completion Date :||December 19, 2019|
Device: AQUABEAM System
To utilizes proprietary heat-free high-pressure waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
Active Comparator: Control
Transurethral Resection of the Prostate (TURP)
Procedure: Transurethral Resection of the Prostate (TURP)
Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH)
- Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability) [ Time Frame: Three months post-treatment ]The primary safety endpoint is the proportion of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment. Note that the Clavien-Dindo classification scheme is for grading postoperative complications not events that reflect lack of effective treatment.
- Score of IPSS Questionnaire Between Baseline and 6 Months [ Time Frame: Six months post-treatment ]
The primary effectiveness endpoint is the IPSS change score from baseline to 6 months.
International Prostate Symptom Score (IPSS) ranges from 0 to 35. A higher score indicates a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505919
|Principal Investigator:||Peter Gilling, M.D.||Urology BOP|
|Principal Investigator:||Claus Roehrborn, M.D.||UT Southwestern Medical Center|