Acute Hemostasis following Aquablation for the treatment of Benign Prostatic Hyperplasia (non-cancerous enlargement of Prostate)
- Conditions
- Health Condition 1: null- Patients suffering from Lower Urinary Tract Symptoms (LUTS) and bladder outlet obstruction (BOO) as a result of Benign Prostatic Hyperplasia (BPH)
- Registration Number
- CTRI/2017/09/009727
- Lead Sponsor
- PROCEPT BioRobotics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
1. Male
2. Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction
3. Age from 40 through 85 years
4. Prostate size >= 20 ml and <= 150 ml
5. IPSS score >= 12
6. Qmax <= 15ml/s
7. History of inadequate response, contraindication to or refusal of medical therapy
8. Patient is mentally capable and willing to sign a study-specific informed consent form
9. Patient is willing and able to comply with all study requirements
1. BMI >= 42
2. Prostatitis treated with antibiotics within 1 year of enrollment
3. Significant renal impairment
4. Active infection, including urinary tract infection
5. Patients on anticoagulants (if medication cannot be stopped 5 days before and after procedure) or known coagulopathy or platelet disorder (except aspirin below 100mg/d)
6. History of gross haematuria
7. Known allergy to device materials
8. Any severe illness that would prevent complete study participation or confound study results
9. Serious concurrent medical conditions such as heart disease (e.g., myocardial infarction within 30 days, congestive heart failure â?? NYHA Class IV), pulmonary disease or uncontrolled diabetes.
10. Has had an open heart surgery, or cardiac arrest < 180 days prior to the date of informed consent
11. ASA III or higher
12. Participants using systemic immune-suppressants including corticosteroids; unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) for 14 days prior to treatment
13. Known illicit substance abuse
14. Dementia or psychiatric condition that prevents the participant from completing required follow up
15. Contraindication to both general and spinal anesthesia
16. Participating in another investigational study that could affect responses to the study device
17. Subject is unwilling to accept a transfusion should one be required
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of subjects that require electrocautery or any other intervention post 3-way Coleman Balloon Foley (or equivalent) Catheter removal.Timepoint: Baseline through Discharge
- Secondary Outcome Measures
Name Time Method Change in Prostate Volume from BaselineTimepoint: Baseline and 1 Week;Additional exploratory analysis may be performed as necessaryTimepoint: Baseline through subject study exit;Blood loss as measured by a HemoCue PhotometerTimepoint: intraoperatively through catheter insertion, and during recover while 3-way catheter is in place;Change from baseline in IPSSTimepoint: Baseline and 1 Week;Change in Hemoglobin ConcentrationTimepoint: Baseline, Pre-Op, Post-Op, 1-Week;Fluid usageTimepoint: Intraoperative and Post-Operative;Procedure DurationTimepoint: Index Procedure;Time of Discharge Readiness as based on a Discharge Readiness ScaleTimepoint: Recovery through Discharge;Urinary Flow Rate (Qmax) and Post-Void Residual VolumeTimepoint: Baseline and at 1-Week