Prostate Single Port & Laser Enucleation Comparison Trial

NCT06224218 | Recruiting

• 1 other identifier: Study 2023-1335
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Hyperplasia

Outcome Measures

Primary Outcomes (8)

• Operative time

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

  During procedure

• 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

  Before procedure and 7 months after procedure

• 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

  Before procedure and 7 months after procedure

• 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

  Before procedure and 7 months after procedure

• Urinary flow rate

  Measure of the urine flow in mL/s

  Before procedure and 7 months after procedure

• Post void residual volume

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

  Before procedure and 7 months after procedure

• Blood loss during procedure

  Estimate blood loss in mL during procedure

  During procedure

• Hospital stay after procedure

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

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

Secondary Outcomes (3)

• Number of subjects with injuries related to surgical procedures.

  During procedure

• Quality of life due to urinary symptoms

  Before procedure and 7 months after procedure

• Number of subjects with incidental cancer

  2 weeks after procedure

Study Arms (2)

Single Port Robotic Prostatectomy

ACTIVE COMPARATOR

Removal of the prostate using single port robot

Procedure: Single Port Robotic Surgery

Laser Enucleation of the Prostate

ACTIVE COMPARATOR

Enucleation of the prostate with laser surgery

Procedure: Laser Surgery

Interventions

Single Port Robotic Surgery PROCEDURE

Single port Robotic surgery will remove the whole prostate

Single Port Robotic Prostatectomy

Laser Surgery PROCEDURE

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

Laser Enucleation of the Prostate

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Adults unable to consent Prisoners Cognitive impaired adults Coagulopathy

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

UI Health SCB Clinic Department of Urology

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (2)

• Talamini S, Lai A, Palmer C, van de Walle G, Zuberek M, Crivellaro S. Surgical treatment of benign prostatic hyperplasia: Thulium enucleation versus single-port transvesical robotic simple prostatectomy. BJUI Compass. 2023 Jun 22;4(5):549-555. doi: 10.1002/bco2.261. eCollection 2023 Sep.

  PMID: 37636211 RESULT

• Bove AM, Brassetti A, Ochoa M, Anceschi U, D'Annunzio S, Ferriero M, Tuderti G, Misuraca L, Mastroianni R, Cartolano S, Torregiani G, Lombardo R, De Nunzio C, Simone G. Robotic simple prostatectomy vs HOLEP, a 'multi single-center' experiences comparison. Cent European J Urol. 2023;76(2):128-134. doi: 10.5173/ceju.2023.204. Epub 2023 Apr 17.

  PMID: 37483855 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Simone Crivellaro, MD

  University of Illinois at Chicago, Department of Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruben Sauer, MD

CONTACT

3124135288; rsauer1@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Dpt, Vice Chair, Lawrence S. Ross Endowed Professor & Associate Professor of Urology Robotic, Section Chief

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 25, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (1)