Prostate Single Port & Laser Enucleation Comparison Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-88
SponsorUniversity of Illinois at Chicago

About this trial

Surgical treatments for benign prostatic hyperplasia (BPH) are necessary when non-procedural approaches fail to alleviate lower urinary tract symptoms (LUTS) or bladder outlet obstruction (BOO). Open simple prostatectomy and laser enucleation are recommended for prostatic adenoma size greater than 80 ml. Minimally invasive approaches, such as robotic-assisted simple prostatectomy, have gained popularity due to their comparable outcomes with lower morbidity. The introduction of the da Vinci single-port (SP) robotic platform offers potential advantages, but its outcomes have not been thoroughly investigated.

This randomized controlled trial aims to compare the outcomes of SP simple prostatectomy performed using the da Vinci robotic platform versus thulium laser enucleation of the prostate for the treatment of BPH and BOO.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH) who fail conservative treatment with drug therapy are eligible for surgical intervention.

Disqualifiers

Adults unable to consent Prisoners Cognitive impaired adults Coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Single Port Robotic Surgery

    Procedure/Surgery

    Single port Robotic surgery will remove the whole prostate

  • Laser Surgery

    Procedure/Surgery

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

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Single Port Robotic ProstatectomyActive comparator 1 intervention
Group B: Laser Enucleation of the ProstateActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Operative time

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

Time frame
During procedure
2

International Consultation of Incontinence Questionnaire Short Form

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

Time frame
Before procedure and 7 months after procedure
3

Sexual Health Inventory for Men (SHIM)

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

Time frame
Before procedure and 7 months after procedure
4

International Prostate Symptom Score I-PSS

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

Time frame
Before procedure and 7 months after procedure

Secondary outcomes

1

Number of subjects with injuries related to surgical procedures.

Descriptive report of complications during surgery.

Time frame
During procedure
2

Quality of life due to urinary symptoms

If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? 0 1 2 3 4 5 6 0= delighted 1. please 2. mostly satisfied 3. mixed 4. mostly unhappy 5. unhappy 6. terrible

Time frame
Before procedure and 7 months after procedure
3

Number of subjects with incidental cancer

Pathology report of prostate tissue, presence or absence of prostate cancer.

Time frame
2 weeks after procedure

Other outcomes

Sponsors and contacts

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