Clinical Data

Core Clinical Indications and Performance Claims

Aquablation therapy is clinically proven to consistently remove prostate tissue independent of prostate size, prostate shape, or surgeon experience.
Operates with a demonstrated low risk of irreversible complications.
Serves as a primary benign prostatic hyperplasia (BPH) treatment of choice across all prostate anatomies.

Clinical Efficacy and Safety Profile

Functional outcomes derived from a meta-analysis at 1 year post-operative follow-up across $425$ patients with prostate volumes ranging from $20 - 150\,mL$ (with $62\%$ presenting with an obstructive median lobe):
- International Prostate Symptom Score (IPSS) Improvement: $16\,\text{points}$
- Peak Urinary Flow Rate ( $Q_{max}$ ): $20.5\,mL/sec$
- Quality of Life Improvement (IPSS QoL): $3.3\,\text{points}$
- Post-Void Residual (PVR) Improvement: $62\,mL$
- Ejaculatory Dysfunction Rate: $10.8\%$
- Erectile Dysfunction Rate: $0\%$
- Incontinence Rate: $0.5\%$
Surgical Retreatment Rate: $1\%$ average annual surgical retreatment rate established at 5-year follow-up.

Key Clinical Studies and Evidence Base

WATER Study: First FDA pivotal study randomized against the gold standard, Transurethral Resection of the Prostate (TURP), for prostates sized $30 - 80\,mL$ ( $n = 181$ ). Includes 5-year longitudinal follow-up results.
WATER II Study: First prospective multicenter FDA study successfully completed for large prostates sized $80 - 150\,mL$ ( $n = 101$ ).
OPEN WATER Study: First multicenter all-comer study delivering real-world results in prostates ranging from $20 - 150\,mL$ for Aquablation therapy ( $n = 178$ ).
TURP Comparative Benchmark: Evaluated in randomized comparison within prostates sized $30 - 80\,mL$ ( $n = 181$ ).
Long-term efficacy parameters monitored across post-procedure months include:
- Symptom Relief (IPSS)
- Quality of Life (IPSS QoL)
- Peak Urinary Flow Rate ( $Q_{max}$ in $mL/sec$ )
- Post-Void Residual Volume (PVR in $mL$ )

Procedure Standardization and Resection Efficiency

Resection Duration: Average total resection time for Aquablation therapy is $5.8\,\text{minutes}$ across pooled data from WATER and WATER II ( $30 - 150\,mL$ ).
TURP Resection Duration: Average resection time for TURP is $27.4\,\text{minutes}$ in prostates sized $30 - 80\,mL$ .
Consistency: Aquablation achieves a standardized total resection time of $5.8\,\text{minutes}$ regardless of prostate size or anatomical shape.

Hemostasis and Bleeding Management

Hemostasis Technique: Focal bladder neck cautery method.
Transfusion Rate: $0.8\%$ transfusion rate documented across $N = 2,089$ patients.
Anatomical Volume Range: Evaluated in prostate sizes with a median volume of $87\,mL$ and a total range of $20 - 363\,mL$ .

Summary of Key Clinical Takeaways

Symptom Relief: Superior to TURP in symptom relief for prostates sized $50 - 80\,mL$ .
Ejaculatory Safety: Superior safety profile driven by significantly lower rates of ejaculatory dysfunction compared to TURP for prostates sized $30 - 80\,mL$ .
Broad Spectrum Efficacy: Delivers significant symptom relief across all prostates ranging from $20 - 150\,mL$ .
Large Prostate Safety: Represents the only treatment for large prostates ( $80 - 150\,mL$ ) maintaining a low rate of irreversible complications.
Efficiency Consistency: Demonstrates consistent resection times across prostates ranging from $30 - 150\,mL$ .
Real-World Durability: Safety, efficacy, and efficiency outcomes are maintained in real-world clinical practice settings.

Risk, Safety, and Perioperative Considerations

General Risk Profile: All surgical treatments carry inherent side effects. Individual outcomes depend on patient characteristics, disease characteristics, and surgeon experience.
Device Claims: No claim is made that the AquaBeam® Robotic System will cure any medical condition or entirely eliminate diseased tissue. Repeated treatment or alternative therapies may be required. Rx Only.
Most Common Side Effects (Mild and Transient):
- Mild pain or dysuria during urination
- Pelvic discomfort
- Hematuria (blood in urine)
- Inability to empty the bladder (urinary retention)
- Frequent and/or urgent need to urinate
- Bladder or urinary tract infections (UTI)
Access and Anatomical Risks:
- Ejaculatory dysfunction
- Low risk of physical injury to the urethra or rectum at device access pathways
- General surgical risks including anesthesia complications and infection risks (including potential transmission of blood-borne pathogens)
Potential Perioperative Risks and Adverse Events:
- Anesthesia risk
- Bladder or prostate capsule perforation
- Bladder neck contracture
- Bleeding or blood in urine
- Bruising
- Penile or pelvic pain
- Irritative voiding symptoms (dysuria, urgency, frequency)
- Systemic or localized infection
- Transurethral resection (TUR) syndrome
- Electric shock or thermal burn
- Urethral damage causing false passage or stricture
- Rectal incontinence or rectal perforation
- Sexual dysfunction (including both ejaculatory and erectile dysfunction)
- Incontinence or overactive bladder
- Embolism
- Urinary retention

Published Scientific References

Meta-Analysis Study: Elterman D. et al. Meta-analysis with individual data of functional outcomes following Aquablation for lower urinary tract symptoms due to BPH in various prostate anatomies. BMJ Surg Interv Health Technologies. Jun 2021.
WATER 5-Year Trial: Gilling et al. Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH. CJU. Feb 2022.
WATER II 3-Year Trial: Zorn K. et al. Aquablation therapy in large prostates (80–150 cc) for lower urinary tract symptoms due to benign prostatic hyperplasia: WATER II 3-year trial results. BJUI Inter. Oct 2021.
OPEN WATER All-Comers Study: Bach T. et al. First Multi-Center All-Comers Study for the Aquablation Procedure. J Clin Med. Feb 2020.
Focal Cautery Bleeding Study: Elterman D. et al. Focal Bladder Neck Cautery Associated with Low Rate of Post Aquablation Bleeding. CJU. Apr 2021.

Corporate and Device Information

Device Name: AquaBeam® Robotic System
Manufacturer: PROCEPT BioRobotics Corporation
Address: 900 Island Drive, Ste 101, Redwood City, CA 94065, United States
Official Website: www.procept-biorobotics.com
Trademarks: AQUABLATION, AQUABEAM, and PROCEPT BioRobotics are registered trademarks of PROCEPT BioRobotics Corporation.
Document Identifier: ML0333.D