UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

Benign Prostatic Hyperplasia Clinical Trial

Official title:

The UK POST WATERStudy: UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04658056
• Other study ID #: CSP0002
• Status: Not yet recruiting
• Start date: January 2021
• Est. completion date: February 2022

Study information

• Verified date: December 2020
• Source: PROCEPT BioRobotics
• Contact: Angela Lee
• Phone: +46 738417897
• Email: a.lee[@]procept-biorobotics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the WATER Study (NCT02505919) - which was a prospective multi-centre randomized blinded study comparing Aquablation of the prostate with the AQUABEAM Robotic System with standard transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS).

Description:

The study is a post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the WATER Study (NCT02505919) - which was a prospective multi-centre randomized blinded study comparing Aquablation of the prostate with the AQUABEAM Robotic System with standard transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS). In POST WATER, up to 46 WATER Study subjects in the United Kingdom who were active on the study at 36 months will be invited to participate, across 3 clinical study sites in England and Wales. The study will consist of one follow-up time-point at 60 months (5 years) from the time of initial WATER Study treatment date.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: February 2022
• Est. primary completion date: January 2022
• Gender: Male
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Subject was randomized and received treatment in the WATER Study.

2. Subject is mentally capable and willing to sign a study-specific informed consent form

3. Subject is willing and able to comply with all study requirements

Exclusion Criteria:

Dementia or psychiatric condition that prevents the participant from completing required follow up 2. Participating in another investigational study that could affect responses to the study assessments

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Locations

Country	Name	City	State
United Kingdom	Frimley Park Hospital	Camberley	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
PROCEPT BioRobotics

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

Chughtai B, Thomas D. Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc). Adv Ther. 2018 Jun;35(6):832-838. doi: 10.1007/s12325-018-0722-0. Epub 2018 Jun 5. — View Citation

Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. Three-year outcomes after Aquablation therapy co — View Citation

Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. Two-Year Outcomes After Aquablation Compared to — View Citation

Gilling PJ, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Roehrborn C. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes. Urolo — View Citation

Pimentel MA, Yassaie O, Gilling P. Urodynamic Outcomes After Aquablation. Urology. 2019 Apr;126:165-170. doi: 10.1016/j.urology.2019.01.020. Epub 2019 Feb 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reoperation or Re-intervention at 60 months	Reoperation or Re-intervention at 60 months	60 months
Other	IPSS-QoL at 60 months	International Prostate Symptom Score Quality of Life sub-score	60 months
Other	Qmax at 60 months	Uroflowmetry measurement of voided urine (in milliliters) per unit of time (in seconds)	60 months
Other	PVR at 60 months	Post-void residual urine test	60 months
Other	Erectile function at 60 months	IIEF-15 score	60 months
Other	MSHQ-EjD at 60 months	Assessment of ejaculatory function/dysfunction	60 months
Primary	Long-term effectiveness as measured by IPSS at 60 months	International Prostate Symptom Score at 60 months as compared to baseline	60 months following original surgical intervention
Primary	Long-term safety as measured by adverse events at 60 months	The proportion of subjects with adverse events classified as Clavien-Dindo Grade 2 or higher or any grade 1 event resulting in persistent disability	60 months following original surgical intervention