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Procedure
HoLEP Sheath Sizes for Enlarged Prostate
N/A
Recruiting
Led By Hazem Elmansy
Research Sponsored by Thunder Bay Regional Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males over 50 years of age at the time of enrollment
Failed medical (non-surgical) treatment
Must not have
Previous surgical treatment for BPH
History of prostate cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post-procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare the outcomes of using different sizes of scopes for Holmium laser enucleation of the prostate (HoLEP). Some believe that larger scopes offer better visualization and efficiency, while
Who is the study for?
This trial is for men with benign prostatic hyperplasia (BPH), which means they have an enlarged prostate. The study is looking for participants who haven't had previous treatments that would affect the outcome of this trial.
What is being tested?
The study compares two sizes of scopes used in a laser surgery called HoLEP to treat BPH. One group will undergo the procedure with a 22F sheath size, while another will use a larger 26F sheath, to see which results in better outcomes and fewer complications.
What are the potential side effects?
Potential side effects may include discomfort or trauma to the urethra, bleeding during or after surgery, bladder neck contracture (narrowing), and urethral stricture disease (a condition where the urine flow is restricted).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man over 50 years old.
Select...
My condition did not improve with medication.
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My prostate was larger than 80 ml before surgery.
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I have been referred to a urologist for severe urinary symptoms due to an enlarged prostate.
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My prostate symptoms are severe, affecting my quality of life and my urine flow is very slow.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery for an enlarged prostate.
Select...
I have a history of prostate cancer.
Select...
My prostate is smaller than 80 mL.
Select...
I have bladder control issues due to nerve problems.
Select...
I have had urethral stenosis or treatment for it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post-procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Comparison of Operating Time
Secondary study objectives
Continence status
International Prostate Symptom Score
Length of Hospital Stay
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: 26F Sheath SizeActive Control1 Intervention
Comparator arm for procedures using 26F sheath size
Group II: 22F Sheath SizeActive Control1 Intervention
Comparator arm for procedures using 22F sheath size
Find a Location
Who is running the clinical trial?
Thunder Bay Regional Health Research InstituteLead Sponsor
10 Previous Clinical Trials
719 Total Patients Enrolled
Hazem ElmansyPrincipal InvestigatorThunder Bay Regional Health Sciences Centre