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

NCT ID: NCT04658056

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-02-28

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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WATER AQUABEAM Robotic System cohort

WATER Study subjects previously-treated with Aquablation of the prostate with the AQUABEAM Robotic System for lower urinary tract symptoms associated with BPH.

No interventions assigned to this group

WATER TURPS cohort

WATER Study subjects previously-treated with standard transurethral resection of the prostate (TURP) for lower urinary tract symptoms associated with BPH.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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PROCEPT BioRobotics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claus Roehrborn, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical

Peter Gilling, MD

Role: PRINCIPAL_INVESTIGATOR

Tauranga Urology Research Limited

Locations

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Frimley Park Hospital

Camberley, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Angela Lee

Role: CONTACT

Phone: +46 738417897

Email: [email protected]

Facility Contacts

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Alexandra Edwards, RN

Role: primary

References

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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 compared to TURP: results from a blinded randomized trial. Can J Urol. 2020 Feb;27(1):10072-10079.

Reference Type RESULT
PMID: 32065861 (View on PubMed)

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 TURP: Efficacy and Ejaculatory Improvements Sustained. Adv Ther. 2019 Jun;36(6):1326-1336. doi: 10.1007/s12325-019-00952-3. Epub 2019 Apr 26.

Reference Type RESULT
PMID: 31028614 (View on PubMed)

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.

Reference Type RESULT
PMID: 30721737 (View on PubMed)

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. Urology. 2019 Mar;125:169-173. doi: 10.1016/j.urology.2018.12.002. Epub 2018 Dec 12.

Reference Type RESULT
PMID: 30552937 (View on PubMed)

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.

Reference Type RESULT
PMID: 29873008 (View on PubMed)

Other Identifiers

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CSP0002

Identifier Type: -

Identifier Source: org_study_id