Benign Prostatic HyperplasiaNCT03062111
Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP)
A study testing ProTouch Laser Enucleation of Prostate (LEP) and Transurethral Resection of Prostate (TURP) in people with Benign Prostatic Hyperplasia, run by Boston University at 1 site in United States.
Trial summary
Benign prostatic hyperplasia (BPH) refers to the proliferation of smooth muscle and epithelial cells of the prostate gland. The enlarged gland has the potential to result in lower urinary tract symptoms (LUTS) secondary to either bladder outlet obstruction or increased muscle tone and resistance, or both. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- ProTouch Laser Enucleation of Prostate (LEP) and Transurethral Resection of Prostate (TURP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2017to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Age > 50-80 years
- Prostate gland size 50-100g
- Failure of nonoperative therapy
- IPSS 8+
- FR <15ml/s
Show all 10Show fewer
- PVR <250
- If PVR is 250-400 then pre-operative urodynamics will be indicated
- Language: English, Spanish, Haitian Creole, French, Portuguese
- Willing to randomize
Who cannot join
- Neurogenic bladder
- PVR >400ml
- IPSS <8
- FR >15ml/Indwelling catheter
- History of prostate cancer
- History of urethral stricture or vesicourethral anastomotic stricture
Show all 10Show fewer
- Unable to be placed in lithotomy position
- Unable to undergo general or spinal anesthesia
- Unable to consent
- Untreated or uncorrected coagulopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP): a Prospective Study Comparing Outcomes
Benign prostatic hyperplasia (BPH) refers to the proliferation of smooth muscle and epithelial cells of the prostate gland. The enlarged gland has the potential to result in lower urinary tract symptoms (LUTS) secondary to either bladder outlet obstruction or increased muscle tone and resistance, or both.
For decades transurethral resection of the prostate (TURP) has been the gold standard for treatment of symptomatic BPH that is refractory to nonoperative management. This is a surgical intervention aimed to reduce the size of the prostate gland. However, over the past fifteen years, many alternative therapies have been introduced including laser enucleation of the prostate (LEP). LEP has numerous advantages including decreased blood loss and length of hospital stay as well as increased effectiveness and safety for large prostate gland sizes (>80g).
Read the detailed description
The purpose of this study is to compare the effectiveness of TURP to LEP using the ProTouch laser technology. While TURP has historically been the gold standard, LEP has become more widespread and is arguably a safer and more effective therapy for the patient. TURP is still widely performed because it is a traditional therapy with decades of data to support its efficacy, despite higher volume of blood loss and risk for TUR syndrome. In comparison, there is some data demonstrating that Holmium Laser Enucleation of the Prostate can have similar efficacy but may have longer operative times. The ProTouch laser is comparable to the Holmium laser but additionally provides improved hemostasis and tissue vaporization. There is little to no data comparing LEP with the ProTouch laser to TURP. This study will directly compare the efficacy of these two treatment methods by enrolling eligible subjects and comparing outcomes.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- ProTouch Laser Enucleation of Prostate (LEP), Transurethral Resection of Prostate (TURP)
- Keywords
- Laser Enucleation of Prostate (LEP), Transurethral Resection of Prostate (TURP)
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProTouch Laser Enucleation of Prostate (LEP)Procedure or surgery
Laser enucleation of the prostate is a standard form of treatment for BPH used widely. The ProTouch laser is established to be safe and is newer than the holmium laser.
Transurethral Resection of Prostate (TURP)Procedure or surgery
TURP has been considered a gold standard for treatment of BPH in which rigid resectoscopes with bipolar cautery are used to endoscopically resect prostatic tissue.
| Study group | Role | What they receive |
|---|---|---|
| ProTouch Laser Enucleation of Prostate | Active comparator | The intervention for this group is that the patient will undergo endoscopic ProTouch Laser Enucleation of Prostate (LEP).The laser is used to enucleate large pieces of prostatic tissue which is followed by further ablation of the tissue so that no fragments are left in the bladder Receives: Procedure: ProTouch Laser Enucleation of Prostate (LEP) |
| Transurethral Resection of Prostate | Active comparator | The intervention for this group that the patient will undergo endoscopic Transurethral Resection of Prostate (TURP) using bipolar cautery. The prostate is essentially shaved down using sequential cuts and cautery. Receives: Procedure: Transurethral Resection of Prostate (TURP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary Flow Rate
Velocity (in cc/sec) of the urine flow
Measured: From time of randomization and ultimately at 24 months
Secondary outcomes (5)
Quality of Life score
Survey to determine how satisfied the patient is with urination
Measured: From time of randomization and ultimately at 24 months
Blood loss
Amount of blood loss during surgery.
Measured: During surgery (full length of operative time)
Catheter time
the amount of time a catheter must stay in place postoperatively
Measured: From time of surgery to up to 3 weeks after surgery.
Post void residual
Amount of urine remaining in the bladder after voiding
Measured: From time of randomization and ultimately at 24 months
Sexual Health Inventory for Men (SHIM)
Survey to assess baseline sexual function and whether this is affected by intervention type
Measured: From time of randomization and ultimately at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start23 Oct 2017
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Why it stopped: Study was stopped due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaun Wason, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062111
- Sponsor's protocol ID
- H-36011
- Status last verified
- Jan 2021
- First submitted
- 30 Jan 2017
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP): a Prospective Study Comparing Outcomes
- ClinicalTrials.gov ID
- NCT03062111
- Acronym / sponsor ID
- H-36011
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Laser Enucleation of Prostate (LEP), Transurethral Resection of Prostate (TURP)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to low enrollment.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 23 Feb 2017 (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.
Benign prostatic hyperplasia (BPH) refers to the proliferation of smooth muscle and epithelial cells of the prostate gland. The enlarged gland has the potential to result in lower urinary tract symptoms (LUTS) secondary to either bladder outlet obstruction or increased muscle tone and resistance, or both.
For decades transurethral resection of the prostate (TURP) has been the gold standard for treatment of symptomatic BPH that is refractory to nonoperative management. This is a surgical intervention aimed to reduce the size of the prostate gland. However, over the past fifteen years, many alternative therapies have been introduced including laser enucleation of the prostate (LEP). LEP has numerous advantages including decreased blood loss and length of hospital stay as well as increased effectiveness and safety for large prostate gland sizes (>80g).
Detailed description
The purpose of this study is to compare the effectiveness of TURP to LEP using the ProTouch laser technology. While TURP has historically been the gold standard, LEP has become more widespread and is arguably a safer and more effective therapy for the patient. TURP is still widely performed because it is a traditional therapy with decades of data to support its efficacy, despite higher volume of blood loss and risk for TUR syndrome. In comparison, there is some data demonstrating that Holmium Laser Enucleation of the Prostate can have similar efficacy but may have longer operative times. The ProTouch laser is comparable to the Holmium laser but additionally provides improved hemostasis and tissue vaporization. There is little to no data comparing LEP with the ProTouch laser to TURP. This study will directly compare the efficacy of these two treatment methods by enrolling eligible subjects and comparing outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProTouch Laser Enucleation of Prostate | Active comparator | Procedure: ProTouch Laser Enucleation of Prostate (LEP)The intervention for this group is that the patient will undergo endoscopic ProTouch Laser Enucleation of Prostate (LEP).The laser is used to enucleate large pieces of prostatic tissue which is followed by further ablation of the tissue so that no fragments are left in the bladder |
| Transurethral Resection of Prostate | Active comparator | Procedure: Transurethral Resection of Prostate (TURP)The intervention for this group that the patient will undergo endoscopic Transurethral Resection of Prostate (TURP) using bipolar cautery. The prostate is essentially shaved down using sequential cuts and cautery. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male
- Age > 50-80 years
- Prostate gland size 50-100g
- Failure of nonoperative therapy
- IPSS 8+
Key exclusion criteria (10 listed)
- Neurogenic bladder
- PVR >400ml
- IPSS <8
- FR >15ml/Indwelling catheter
- History of urethral stricture or vesicourethral anastomotic stricture
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 |
|---|---|---|
| ProTouch Laser Enucleation of Prostate (LEP)Laser enucleation of the prostate is a standard form of treatment for BPH used widely. The ProTouch laser is established to be safe and is newer than the holmium laser. | Procedure or surgery | ProTouch Laser Enucleation of Prostate |
| Transurethral Resection of Prostate (TURP)TURP has been considered a gold standard for treatment of BPH in which rigid resectoscopes with bipolar cautery are used to endoscopically resect prostatic tissue. | Procedure or surgery | Transurethral Resection of Prostate |
Primary outcome
Change in Urinary Flow Rate
Time frame: From time of randomization and ultimately at 24 months
Velocity (in cc/sec) of the urine flow
5 secondary outcomes
Quality of Life score
Time frame: From time of randomization and ultimately at 24 months
Blood loss
Time frame: During surgery (full length of operative time)
Catheter time
Time frame: From time of surgery to up to 3 weeks after surgery.
Post void residual
Time frame: From time of randomization and ultimately at 24 months
Sexual Health Inventory for Men (SHIM)
Time frame: From time of randomization and ultimately at 24 months
Results and safety
The study was stopped early (reason given: Study was stopped due to low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Shaun Wason, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProTouch Laser Enucleation of Prostate (LEP) and Transurethral Resection of Prostate (TURP) in people with Benign Prostatic Hyperplasia, run by Boston University 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 10 inclusion and 10 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: stopped early, as of the sponsor's last update on 3 Feb 2021. 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?
The study was stopped early (reason given: Study was stopped due to low enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urinary Flow Rate (time frame: From time of randomization and ultimately at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2021.