Recruiting

Prostate & Laser

Sponsor:

University of Illinois at Chicago

Code:

NCT06224218

Conditions

Prostate Hyperplasia

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Single Port Robotic Surgery

Laser Surgery

Study Details

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

Study ID

NCT06224218

Start date

Jan 15, 2024

Status verified date

May, 2024

Completion date

Aug 15, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Adults unable to consent Prisoners Cognitive impaired adults Coagulopathy

Study Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Single Port Robotic Prostatectomy

Removal of the prostate using single port robot

active comparator: Laser Enucleation of the Prostate

Enucleation of the prostate with laser surgery

Interventions

Single Port Robotic Surgery

Single port Robotic surgery will remove the whole prostate

Laser Surgery

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

Primary outcome measure

  • Operative time [ Time Frame: During procedure ]
  • International Consultation of Incontinence Questionnaire Short Form [ Time Frame: Before procedure and 7 months after procedure ]
  • Sexual Health Inventory for Men (SHIM) [ Time Frame: Before procedure and 7 months after procedure ]
  • International Prostate Symptom Score I-PSS [ Time Frame: Before procedure and 7 months after procedure ]
  • Urinary flow rate [ Time Frame: Before procedure and 7 months after procedure ]
  • Post void residual volume [ Time Frame: Before procedure and 7 months after procedure ]
  • Blood loss during procedure [ Time Frame: During procedure ]
  • Hospital stay after procedure [ Time Frame: From end of procedure to discharge home (up to 30 days ) ]

Central Contacts and Locations

Central contacts

Ruben Sauer, MD

3124135288rsauer1@uic.edu

Locations

UI Health SCB Clinic Department of Urology

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Ruben Sauer, MD

312-413-5288rsauer1@uic.edu

Principal Investigator:

Simone Crivellaro, MD

More Information

Sponsor

University of Illinois at Chicago

Last update posted

May 16, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2024-05-16.