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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| WATER TURPS cohort | WATER Study subjects previously-treated with standard transurethral resection of the prostate (TURP) for lower urinary tract symptoms associated with BPH. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Reoperation or Re-intervention at 60 months | Reoperation or Re-intervention at 60 months | 60 months |
| IPSS-QoL at 60 months | International Prostate Symptom Score Quality of Life sub-score |
Inclusion Criteria:
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
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The target patient population is subjects who were enrolled in the WATER Study (with symptomatic BPH) who were randomized to treatment with either the Aquablation procedure or TURP.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Lee | Contact | +46 738417897 | a.lee@procept-biorobotics.com |
| Name | Affiliation | Role |
|---|---|---|
| Claus Roehrborn, MD | UT Southwestern Medical | Principal Investigator |
| Peter Gilling, MD | Tauranga Urology Research Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frimley Park Hospital | Camberley | Surrey | GU16 7UJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32065861 | Result | 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. | |
| 31028614 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 21, 2023 | |
| Reset | Mar 14, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 21, 2023 | Mar 14, 2024 |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| 60 months |
| Qmax at 60 months | Uroflowmetry measurement of voided urine (in milliliters) per unit of time (in seconds) | 60 months |
| PVR at 60 months | Post-void residual urine test | 60 months |
| Erectile function at 60 months | IIEF-15 score | 60 months |
| MSHQ-EjD at 60 months | Assessment of ejaculatory function/dysfunction | 60 months |
| 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. |
| 30721737 | Result | 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. |
| 30552937 | Result | 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. |
| 29873008 | Result | 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. |
| D052801 |
| Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |