Benign Prostatic HyperplasiaExpHoNCT03583034
Outcomes and Complications of Holmium Laser Enucleation of the Prostate in Expert Hands
An observational study of Benign Prostatic Hyperplasia, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The efficacy and safety of holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) have been comprehensively assessed. However, HoLEP is considered as a challenging procedure with a steep learning curve. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Holmium laser enucleation of the prostate (HoLEP)
- Type of treatment
- Surgery or procedure
- How many people
- 275 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jun 2018to 18 Jun 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients submitted to surgery for bladder outlet obstruction (BOO) due to BPH
Who may be able to join
- Patients with lower urinary tract symptoms due to benign prostatic hyperplasia
Who cannot join
- neurological diseases; previous surgery on the lower urinary tract (urethra/prostate)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, MI, 20132
Paolo Capogrosso, MD, +390226437286, paolo.capogrosso@gmail.com
About this study
Official title: Prospective Assessment of Outcomes and Complications of Patients Submitted to Holmium Laser Enucleation of the Prostate (HoLEP) in a High Volume Center
The efficacy and safety of holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) have been comprehensively assessed. However, HoLEP is considered as a challenging procedure with a steep learning curve. As such, HoLEP is not as yet considered the gold standard for the surgical treatment of LUTS/BPH by international clinical guidelines.
The investigators aim to assess the complications and outcomes of patients treated with HoLEP by high volume surgeons, in order to provide data on the safety of the procedure and identify the profile of patients who may benefit from a dedicated clinical management to reduce the risk of post-operative complications.
Read the detailed description
This is a prospective case-series study collecting data of patients treated with HoLEP at a single academic center. Patients submitted to surgery for bladder outlet obstruction (BOO) due to BPH will be consecutively included. All surgeries will be performed by two experienced surgeons with more than 1000 procedures performed (FM; GB).
Patients with neurological diseases and those with a history of previous surgery of the lower urinary tract (e.g. urethra and prostate surgery) will be excluded.
At the time of primary screening, all patients will be assessed with a comprehensive medical history; other pre-operative data will include: prostate volume (as assessed with trans-rectal prostate ultrasound); uroflowmetry parameters; total Prostate specific Antigen (PSA); baseline haemoglobin and creatinine level. Moreover, all patients will be invited to fill psychometric validated questionnaires assessing pre-operative urinary and sexual function, thus including: the International Prostatic Symptoms Score (IPSS); the International Index of Erectile Function (IIEF); the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF); and the Overactive Bladder Questionnaire (OABq). Moreover, urinary continence (UC) will be further assessed with a single question, and UC defined as no-pad use. Patients' medications will be also recorded.
Intra-operative data will be collected at the time of surgery, including: patients' systolic blood pressure; laser settings; enucleation efficiency (weight of enucleated tissue divided by lasing time) and morcellation efficiency (weight of enucleated tissue divided by morcellation time). Moreover, surgeons will be requested to provide a subjective estimation of the difficulty of the procedure with a 10-point Likert scale.
Post-operative data including: length of stay; timing of catheter removal and complications, will be also collected.
All patients will be re-assessed at 1 week after surgery to check for UC. Subjective symptoms, as assessed with validated questionnaires (IPSS; IIEF, ICIQ-SF; OABq), along with post-operative complications and medications used, will be firstly assessed at 1 month after surgery. All patients will undergo a first uroflowmetry evaluation at 3 months after surgery; at this time-point data on blood tests (total PSA, haemoglobin and creatinine), urine culture and symptoms scores will be collected.
A final assessment will be performed at 1 year after surgery including: blood tests, uroflowmetry, IPSS, IIEF, ICIQ-SF, OABq and complications.
Over the follow-up period, the prevalence of patients needing medications for disturbing symptoms will be recorded; moreover, pelvic floor training (PFT) will be suggested to each patient reporting pad-use for urinary incontinence.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Holmium laser enucleation of the prostate (HoLEP)
- Keywords
- HoLEP, Prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium laser enucleation of the prostate (HoLEP)Procedure or surgery
Surgery for benign prostatic hyperplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcomes as assessed with IPSS questionnaire
functional urinary outcomes will be assessed with IPSS questionnaire at different time points over the first year after surgery.
Measured: 12 months
Secondary outcomes (1)
Identification of clinical characteristics associated with risk of post-operative complications (recorded according to the Clavien-Dindo classification)
The association between clinical characteristics (e.g. age, BMI, comorbidities, prostate volume) and the risk of post-operative complications will be assessed
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start18 Jun 2018
- Primary completion18 Apr 2019 (estimated)
- Study completion18 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 275 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Montorsi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583034
- Sponsor's protocol ID
- ExpHo study
- Acronym
- ExpHo
- Status last verified
- Jul 2018
- First submitted
- 18 Jun 2018
- Last updated
- 12 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Capogrosso P, Ventimiglia E, Fallara G, Schifano N, Costa A, Candela L, Pellegrino F, Colandrea G, Cignoli D, De Angelis M, Belladelli F, Longoni M, Avesani G, Lanzaro F, Scattoni V, Deho F, Salonia A, Briganti A, Montorsi F. Holmium Laser Enucleation of the Prostate Is Associated with Complications and Sequelae Even in the Hands of an Experienced Surgeon Following Completion of the Learning Curve. Eur Urol Focus. 2023 Sep;9(5):813-821. doi: 10.1016/j.euf.2023.03.018. Epub 2023 Apr 15.
PubMed 37069007
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Outcomes and Complications of Patients Submitted to Holmium Laser Enucleation of the Prostate (HoLEP) in a High Volume Center
- ClinicalTrials.gov ID
- NCT03583034
- Acronym / sponsor ID
- ExpHo / ExpHo study
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- HoLEP, Prostate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 18 Apr 2019 (estimated)
- Study completion
- 18 Jun 2020 (estimated)
- First posted
- 11 Jul 2018 (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.
The efficacy and safety of holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) have been comprehensively assessed. However, HoLEP is considered as a challenging procedure with a steep learning curve. As such, HoLEP is not as yet considered the gold standard for the surgical treatment of LUTS/BPH by international clinical guidelines.
The investigators aim to assess the complications and outcomes of patients treated with HoLEP by high volume surgeons, in order to provide data on the safety of the procedure and identify the profile of patients who may benefit from a dedicated clinical management to reduce the risk of post-operative complications.
Detailed description
This is a prospective case-series study collecting data of patients treated with HoLEP at a single academic center. Patients submitted to surgery for bladder outlet obstruction (BOO) due to BPH will be consecutively included. All surgeries will be performed by two experienced surgeons with more than 1000 procedures performed (FM; GB).
Patients with neurological diseases and those with a history of previous surgery of the lower urinary tract (e.g. urethra and prostate surgery) will be excluded.
At the time of primary screening, all patients will be assessed with a comprehensive medical history; other pre-operative data will include: prostate volume (as assessed with trans-rectal prostate ultrasound); uroflowmetry parameters; total Prostate specific Antigen (PSA); baseline haemoglobin and creatinine level. Moreover, all patients will be invited to fill psychometric validated questionnaires assessing pre-operative urinary and sexual function, thus including: the International Prostatic Symptoms Score (IPSS); the International Index of Erectile Function (IIEF); the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF); and the Overactive Bladder Questionnaire (OABq). Moreover, urinary continence (UC) will be further assessed with a single question, and UC defined as no-pad use. Patients' medications will be also recorded.
Intra-operative data will be collected at the time of surgery, including: patients' systolic blood pressure; laser settings; enucleation efficiency (weight of enucleated tissue divided by lasing time) and morcellation efficiency (weight of enucleated tissue divided by morcellation time). Moreover, surgeons will be requested to provide a subjective estimation of the difficulty of the procedure with a 10-point Likert scale.
Post-operative data including: length of stay; timing of catheter removal and complications, will be also collected.
All patients will be re-assessed at 1 week after surgery to check for UC. Subjective symptoms, as assessed with validated questionnaires (IPSS; IIEF, ICIQ-SF; OABq), along with post-operative complications and medications used, will be firstly assessed at 1 month after surgery. All patients will undergo a first uroflowmetry evaluation at 3 months after surgery; at this time-point data on blood tests (total PSA, haemoglobin and creatinine), urine culture and symptoms scores will be collected.
A final assessment will be performed at 1 year after surgery including: blood tests, uroflowmetry, IPSS, IIEF, ICIQ-SF, OABq and complications.
Over the follow-up period, the prevalence of patients needing medications for disturbing symptoms will be recorded; moreover, pelvic floor training (PFT) will be suggested to each patient reporting pad-use for urinary incontinence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients submitted to surgery for bladder outlet obstruction (BOO) due to BPH
Key inclusion criteria (1 listed)
- Patients with lower urinary tract symptoms due to benign prostatic hyperplasia
Key exclusion criteria (1 listed)
- neurological diseases; previous surgery on the lower urinary tract (urethra/prostate)
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 |
|---|---|---|
| Holmium laser enucleation of the prostate (HoLEP)Surgery for benign prostatic hyperplasia | Procedure or surgery | – |
Primary outcome
Functional outcomes as assessed with IPSS questionnaire
Time frame: 12 months
functional urinary outcomes will be assessed with IPSS questionnaire at different time points over the first year after surgery.
1 secondary outcome
Identification of clinical characteristics associated with risk of post-operative complications (recorded according to the Clavien-Dindo classification)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Derived from this study: PubMed 37069007Capogrosso P, Ventimiglia E, Fallara G, Schifano N, Costa A, Candela L, Pellegrino F, Colandrea G, Cignoli D, De Angelis M, Belladelli F, Longoni M, Avesani G, Lanzaro F, Scattoni V, Deho F, Salonia A, Briganti A, Montorsi F. Holmium Laser Enucleation of the Prostate Is Associated with Complications and Sequelae Even in the Hands of an Experienced Surgeon Following Completion of the Learning Curve. Eur Urol Focus. 2023 Sep;9(5):813-821. doi: 10.1016/j.euf.2023.03.018. Epub 2023 Apr 15.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by IRCCS San Raffaele at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 12 Jul 2018. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Capogrosso, MD (+390226437286, capogrosso.paolo@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcomes as assessed with IPSS questionnaire (time frame: 12 months). 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 NCT03583034, which also lists 1 linked publication.
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 12 Jul 2018.