Study Summary
This trial will study a device to help men with BPH urinary retention return to volitional voiding and lower their post-void residual.
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 56 days
28 days
Primary safety endpoint
Quality of Life Measurement
Secondary Safety Endpoint 1
Secondary Safety Endpoint 2
Secondary Safety Endpoint 3
The change in Post Void Residual from baseline to day 28 will be measured and reported
56 days
Bacterial Infection Monitoring
Trends in Renal Function
Urinary Bother Inventory
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
single arm study
1 of 1
Experimental Treatment
95 Total Participants · 1 Treatment Group
Primary Treatment: single arm study · No Placebo Group · N/A
single arm study
Device
Experimental Group · 1 Intervention: blue halo coil catheter · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 56 days
Who is running the clinical trial?
Blue Halo Biomedical, LLCLead Sponsor
Eligibility Criteria
Age 18+ · Male Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have difficulty urinating due to an enlarged prostate that is larger than 50cc or has a prostatic urethral length of more than 5cm.
You can still participate if you are taking alpha-blocking or 5-alpha-reductase inhibitor drugs.
References
- Fontanarosa PB, Roush WR. Acute urinary retention. Emerg Med Clin North Am. 1988 Aug;6(3):419-37.
- Samm BJ, Dmochowski RR. Urologic emergencies. Conditions affecting the kidney, ureter, bladder, prostate, and urethra. Postgrad Med. 1996 Oct;100(4):177-80, 183-4. doi: 10.3810/pgm.1996.10.100.
- Andersen JT, Nickel JC, Marshall VR, Schulman CC, Boyle P. Finasteride significantly reduces acute urinary retention and need for surgery in patients with symptomatic benign prostatic hyperplasia. Urology. 1997 Jun;49(6):839-45. doi: 10.1016/s0090-4295(97)00185-4.
- de la Rosette JJ, Beerlage HP, Debruyne FM. Role of temporary stents in alternative treatment of benign prostatic hyperplasia. J Endourol. 1997 Dec;11(6):467-72. doi: 10.1089/end.1997.11.467.
- Williams G. Stents in the lower urinary tract. European Urology Update Series 1992. Vol l (1), p 82-87.
- Devonec M, Dahlstrand C. Temporary urethral stenting after high-energy transurethral microwave thermotherapy of the prostate. World J Urol. 1998;16(2):120-3. doi: 10.1007/s003450050037.
- Feneley RC, Hopley IB, Wells PN. Urinary catheters: history, current status, adverse events and research agenda. J Med Eng Technol. 2015;39(8):459-70. doi: 10.3109/03091902.2015.1085600. Epub 2015 Sep 18. Erratum In: J Med Eng Technol. 2016;40(2):59.
- Hammond, G. A Prospective Evaluation of the Catheter Science M3 "Mini Catheter" for Patients with Prostatic Obstruction. AUA Poster Presentation MP73-06, San Francisco, California, May, 2018
- Sabharwal S, Sabharwal S. Using Temporary Prostatic Stents to Eliminate Bacterial Colonization in Men with Chronic Indwelling Catheters: A Pilot Study. Cureus. 2018 Aug 16;10(8):e3152. doi: 10.7759/cureus.3152.
- Garcia MM, Gulati S, Liepmann D, Stackhouse GB, Greene K, Stoller ML. Traditional Foley drainage systems--do they drain the bladder? J Urol. 2007 Jan;177(1):203-7; discussion 207. doi: 10.1016/j.juro.2006.08.101.
- Shore ND, Dineen MK, Saslawsky MJ, Lumerman JH, Corica AP. A temporary intraurethral prostatic stent relieves prostatic obstruction following transurethral microwave thermotherapy. J Urol. 2007 Mar;177(3):1040-6. doi: 10.1016/j.juro.2006.10.059.
- 2022. "Evaluation of the "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05714488.
Frequently Asked Questions
Are any new participants being accepted into this experiment?
"Affirmative. Clinicaltrials.gov provides evidence that this research is actively recruiting, commencing on August 1st 2022 and last amended on January 26th 2023. It requires 95 individuals to enrol from 3 distinct locations." - Anonymous Online Contributor
Unverified Answer
What is the cap on participants for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this medical experiment was first advertised on August 1st 2022 and is currently recruiting participants. 95 patients need to be enrolled from 3 separate locations." - Anonymous Online Contributor
Unverified Answer