Prostate HyperplasiaNCT06224218
Prostate Single Port & Laser Enucleation Comparison Trial
A study testing Single Port Robotic Surgery and Laser Surgery in people with Prostate Hyperplasia, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years, men only
- Conditions the study is for
- Prostate Hyperplasia
- What is being tested?
- Single Port Robotic Surgery and Laser Surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH) who fail conservative treatment with drug therapy are eligible for surgical intervention.
Who cannot join
- Adults unable to consent Prisoners Cognitive impaired adults Coagulopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UI Health SCB Clinic Department of Urology
Chicago, Illinois, 60612
Ruben Sauer, MD, 312-413-5288, rsauer1@uic.edu
Simone Crivellaro, MD
About this study
Official title: Randomized Controlled Trial Comparing Single Port Simple Prostatectomy and Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia
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.
Read the detailed description
Patients diagnosed with symptomatic BPH and eligible for surgical intervention will be randomized to undergo either SP robotic simple prostatectomy or thulium laser enucleation of the prostate. Primary outcomes will include perioperative parameters (operative time, estimated blood loss, hospital stay), postoperative complications, and functional outcomes (urinary symptoms, urinary flow rate). Secondary outcomes will evaluate perioperative and postoperative complications, oncologic outcomes, and patient-reported quality of life measures.
In a recent retrospective study at UI Health from 2017 to 2021, investigators compared 103 procedures, SP robotic prostatectomy versus laser enucleation, 34 SP robotic prostatectomy and 69 laser enucleations. There was no difference in any complication at 30-day post-surgery (21.2% vs. 21.7%, p=0.9517). Investigators recognize SP robotic surgery leads to longer operating times, due to docking the instrument and closing the incision, as well as longer catheter times to allow the cystostomy to heal. While the laser enucleation may be considered less invasive, as no incision is required, the instrumentation of the urethra could lead to urethral strictures. This study aims to provide valuable insights into the clinical outcomes of single port simple prostatectomy using SP robotic platform, compared to laser enucleation of the prostate prospectively. The results of this trial will help guide clinicians and patients in selecting the most appropriate surgical intervention for symptomatic BPH, considering both functional outcomes and morbidity. Both procedures are currently performed at UI Health, they are FDA approved, therefore this is not a safety study. Subject insurance will not impact which subject will receive one procedure or the other, as both procedures are recommended on the American Urological Association guidelines for Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia.
The study will be a randomized controlled trial comparing SP simple prostatectomy vs laser enucleation of the prostate. The study findings will improve clinical decision-making and aid in optimizing patient outcomes in the management of BPH.
- Conditions
- Prostate Hyperplasia
- Being tested
- Single Port Robotic Surgery, Laser Surgery
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Port Robotic SurgeryProcedure or surgery
Single port Robotic surgery will remove the whole prostate
Laser SurgeryProcedure or surgery
Laser enucleation will remove chips of the prostate but keeping intact the prostate capsule.
| Study group | Role | What they receive |
|---|---|---|
| Single Port Robotic Prostatectomy | Active comparator | Removal of the prostate using single port robot Receives: Procedure: Single Port Robotic Surgery |
| Laser Enucleation of the Prostate | Active comparator | Enucleation of the prostate with laser surgery Receives: Procedure: Laser Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Time in minutes from the start to finish of the procedure.
Measured: 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
Measured: Before procedure and 7 months after procedure
Sexual Health Inventory for Men (SHIM)
- How do you rate your confidence to keep an erection? 1 Very low 2 3 4 5 Very high
- How often were your erections hard enough for penetration? 1 Almost never 2 3 4 5Almost always
- How often were you able to maintain your erection after you had penetrated your partner? 1Almost never 2 3 4 5Almost always
- How difficult was it to maintain your erection to completion of intercourse? 1Extremely difficult 2 3 4 5Not difficult
- 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
Measured: Before procedure and 7 months after procedure
International Prostate Symptom Score I-PSS
- How often have you had a sensation of not emptying your bladder completely after you finish urinating?
0= not all
- less than 1 time in 5
- less than half the time
- about half the time
- more than half the time
- almost always
- How often have you had to urinate again less than two hours after you have finished urinating?
0 1 2 3 4 5
- How often have you found you stopped and started again several times when you urinated?
0 1 2 3 4 5
- How often have you found it difficult to postpone urination?
0 1 2 3 4 5
- How often have you had a weak urinary stream?
0 1 2 3 4 5
- How often have you had to push or strain to begin urination?
0 1 2 3 4 5
- 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
Measured: Before procedure and 7 months after procedure
Urinary flow rate
Measure of the urine flow in mL/s
Measured: 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
Measured: Before procedure and 7 months after procedure
Blood loss during procedure
Estimate blood loss in mL during procedure
Measured: During procedure
Hospital stay after procedure
Amount of time spent at the hospital after procedure measure in hours
Measured: From end of procedure to discharge home (up to 30 days )
Secondary outcomes (3)
Number of subjects with injuries related to surgical procedures.
Descriptive report of complications during surgery.
Measured: During procedure
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
- please
- mostly satisfied
- mixed
- mostly unhappy
- unhappy
- terrible
Measured: Before procedure and 7 months after procedure
Number of subjects with incidental cancer
Pathology report of prostate tissue, presence or absence of prostate cancer.
Measured: 2 weeks after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start15 Jan 2024
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Crivellaro, University of Illinois Chicago
- Investigators
- Simone Crivellaro, MD, Principal investigator, University of Illinois at Chicago, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224218
- Sponsor's protocol ID
- Study 2023-1335
- Status last verified
- May 2024
- First submitted
- 4 Jan 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37636211Bove 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.
PubMed 37483855
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Single Port Simple Prostatectomy and Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT06224218
- Acronym / sponsor ID
- Study 2023-1335
- Conditions
- Prostate Hyperplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients diagnosed with symptomatic BPH and eligible for surgical intervention will be randomized to undergo either SP robotic simple prostatectomy or thulium laser enucleation of the prostate. Primary outcomes will include perioperative parameters (operative time, estimated blood loss, hospital stay), postoperative complications, and functional outcomes (urinary symptoms, urinary flow rate). Secondary outcomes will evaluate perioperative and postoperative complications, oncologic outcomes, and patient-reported quality of life measures.
In a recent retrospective study at UI Health from 2017 to 2021, investigators compared 103 procedures, SP robotic prostatectomy versus laser enucleation, 34 SP robotic prostatectomy and 69 laser enucleations. There was no difference in any complication at 30-day post-surgery (21.2% vs. 21.7%, p=0.9517). Investigators recognize SP robotic surgery leads to longer operating times, due to docking the instrument and closing the incision, as well as longer catheter times to allow the cystostomy to heal. While the laser enucleation may be considered less invasive, as no incision is required, the instrumentation of the urethra could lead to urethral strictures. This study aims to provide valuable insights into the clinical outcomes of single port simple prostatectomy using SP robotic platform, compared to laser enucleation of the prostate prospectively. The results of this trial will help guide clinicians and patients in selecting the most appropriate surgical intervention for symptomatic BPH, considering both functional outcomes and morbidity. Both procedures are currently performed at UI Health, they are FDA approved, therefore this is not a safety study. Subject insurance will not impact which subject will receive one procedure or the other, as both procedures are recommended on the American Urological Association guidelines for Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia.
The study will be a randomized controlled trial comparing SP simple prostatectomy vs laser enucleation of the prostate. The study findings will improve clinical decision-making and aid in optimizing patient outcomes in the management of BPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Port Robotic Prostatectomy | Active comparator | Procedure: Single Port Robotic SurgeryRemoval of the prostate using single port robot |
| Laser Enucleation of the Prostate | Active comparator | Procedure: Laser SurgeryEnucleation of the prostate with laser surgery |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH) who fail conservative treatment with drug therapy are eligible for surgical intervention.
Key exclusion criteria (1 listed)
- Adults unable to consent Prisoners Cognitive impaired adults Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Port Robotic SurgerySingle port Robotic surgery will remove the whole prostate | Procedure or surgery | Single Port Robotic Prostatectomy |
| Laser SurgeryLaser enucleation will remove chips of the prostate but keeping intact the prostate capsule. | Procedure or surgery | Laser Enucleation of the Prostate |
Primary outcome
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
3 secondary outcomes
Number of subjects with injuries related to surgical procedures.
Time frame: During procedure
Quality of life due to urinary symptoms
Time frame: Before procedure and 7 months after procedure
Number of subjects with incidental cancer
Time frame: 2 weeks after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Results publication: PubMed 37636211Talamini 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.
- Results publication: PubMed 37483855Bove 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simone Crivellaro, MD principal investigator
University of Illinois at Chicago, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Port Robotic Surgery and Laser Surgery in people with Prostate Hyperplasia, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruben Sauer, MD (3124135288, rsauer1@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: During procedure). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06224218, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.