An interventional study of PuraStat hydrogel and the syringe in BPH (Benign Prostatic Hyperplasia) and BPH With Symptomatic Lower Urinary Tract Symptoms, sponsored by Endeavor Health. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Endeavor Health · Not applicable, Interventional, and Supportive care
Randomized, single-blinded investigational study to assess the safety of PuraStat following the Aquablation procedure
This study will evaluate the safety and effectiveness of a device (PuraStat hydrogel and the syringe used to apply it - referred to as PuraStat, designed to help control bleeding after the subject's scheduled Aquablation procedure. To assess its effectiveness, investigators will take a picture of the color of your urethral Foley catheter and grade the amount of blood present 1-3 hours after surgery. Investigators will also examine whether the device helps subjects recover more quickly and be discharged the same day, which currently happens in only 1% of cases.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 50 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Endeavor Health is the lead sponsor of 111 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient will not receive PuraStat after the Aquablation procedure
Receive PuraStat after the Aquablation procedure
Device: PuraStat hydrogel and the syringe
PuraStat device is FDA-approved for other uses, such as gastrointestinal endoscopy and ENT (ear, nose, throat) procedures. Its use in this study for urology is investigational.
Hematuria grade at 1-3 hours postop in the PACU
Grade the amount of blood present 1-3 hours after surgery Scale zero through Five
Time frame: 1 to 3 hours post procedure
Percentage of patients discharged on the same day
Examine whether the device helps recover more quickly and be discharged the same day, which currently happens in only 1% of cases.
Time frame: Postoperative Week 1
Patient Reported Outcome Measure IPSS questionnaire
International Prostate Symptom Score (IPSS), Min 0 Max 35 (Worst symptoms)
Time frame: From Enrollment to 30 days post procedure
Patient Reported Outcome Measures LURN SI-29 questionnaire
Lower Urinary Research Network Symptom Index-29. Max 100 (Worst Symptoms), Min 0 (Best Symptoms). Multiple health domains are being evaluated such as incontinence, pain, voiding, urgency, nocturia, frequency
Time frame: From Enrollment to 30 days post procedure
Patient Reported Outcome Measures SHIM questionnaire
Sexual health inventory for men, Min 1 (Worst Sexual health) Max 25 ( Best Sexual Health)
Time frame: From Enrollment to 30 days post procedure
Patient Reported Outcome Measures MSHQ-EjD questionnaire
Male Sexual Health Questionnaire - Ejaculatory Dysfunction, Min 1 ( Worst) Max 15 ( Best)
Time frame: From Enrollment to 30 days post procedure
Patient Reported Outcome Measures Dysuria questionnaire
Difficult urination, Min 0 Max 5 (Worst)
Time frame: 30 days post procedure
Plan to share: No — Data collected for the study will be published in peer reviewed Journals and in research presentations and abstracts.
Started Aug 2025 (actual). Primary completion is estimated for Sep 2026, 12 months after the start.
Of 152 non-industry interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 203 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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