Prostate Single Port & Laser Enucleation Comparison Trial

PROCEDURE

Single Port Robotic Surgery

Single port Robotic surgery will remove the whole prostate

PROCEDURE

Laser Surgery

Laser enucleation will remove chips of the prostate but keeping intact the prostate capsule.

Operative time

Time frame: During procedure

Time in minutes from the start to finish of the procedure.

International Consultation of Incontinence Questionnaire Short Form

Time frame: Before procedure and 7 months after procedure

How often do you leak urine? never 0 about once a week 1 two or three times a week 2 about once a day 3 several times a day 4 all the time 5 How much urine do you usually leak (whether you wear protection or not)? none 0 a small amount 2 a moderate amount 4 a large amount 6 Overall, how much does leaking urine interfere with your everyday life? 0 (not at all) and 10 (a great deal) 0 1 2 3 4 5 6 7 8 9 10 ICIQ score: sum previous questions. When does urine leak? never - urine does not leak before you can get to the toilet when you cough or sneeze when you are asleep when you are physically active/exercising when you have finished urinating and are dressed for no obvious reason all the time

Sexual Health Inventory for Men (SHIM)

Time frame: Before procedure and 7 months after procedure

1. How do you rate your confidence to keep an erection? 1 Very low 2 3 4 5 Very high 2. How often were your erections hard enough for penetration? 1 Almost never 2 3 4 5Almost always 3. How often were you able to maintain your erection after you had penetrated your partner? 1Almost never 2 3 4 5Almost always 4. How difficult was it to maintain your erection to completion of intercourse? 1Extremely difficult 2 3 4 5Not difficult 5. When you attempted sexual intercourse, how often was it satisfactory for you? 1Almost never 2 3 4 5Almost always Add together the numbers. If the patient's score is 21 or less, erectile dysfunction (ED) should be addressed. 22 - 25: No significant erectile dysfunction 17 - 21: Mild erectile dysfunction 12 - 16: Mild-to-moderate erectile dysfunction 8 - 11: Moderate erectile dysfunction 5 - 7: Severe erectile dysfunction

International Prostate Symptom Score I-PSS

Time frame: Before procedure and 7 months after procedure

1\. How often have you had a sensation of not emptying your bladder completely after you finish urinating? 0= not all 1. less than 1 time in 5 2. less than half the time 3. about half the time 4. more than half the time 5. almost always 2\. How often have you had to urinate again less than two hours after you have finished urinating? 0 1 2 3 4 5 3\. How often have you found you stopped and started again several times when you urinated? 0 1 2 3 4 5 4\. How often have you found it difficult to postpone urination? 0 1 2 3 4 5 5\. How often have you had a weak urinary stream? 0 1 2 3 4 5 6\. How often have you had to push or strain to begin urination? 0 1 2 3 4 5 7\. How many times did you most typically get up each night to urinate from the time you went to bed until the time you got up in the morning? 0 1 2 3 4 5 Sum previous questions to have the score: 0 - 7 = mildly symptomatic; 8 - 19 = moderately 20 - 35 = severely

Urinary flow rate

Time frame: Before procedure and 7 months after procedure

Measure of the urine flow in mL/s

Post void residual volume

Time frame: Before procedure and 7 months after procedure

Amount of urine retained in the bladder after a voluntary void measure with Ultrasound. Volume = length x width x height x 0.52

Blood loss during procedure

Time frame: During procedure

Estimate blood loss in mL during procedure

Hospital stay after procedure

Time frame: From end of procedure to discharge home (up to 30 days )

Amount of time spent at the hospital after procedure measure in hours

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.