BPHPRISSANCT04342533
Prospective Randomized Trial of Irritative Symptoms Severity Assessment After (HoLEP) Versus ThuFLEP
A study testing Thulium fiber laser enucleation of the prostate and Holmium laser enucleation of the prostate in people with BPH and Prostate Obstruction, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
The investigators hypothesize that the functional outcomes of both techniques are comparable. However, ThuFLEP might increase speed recovery of postoperative irritation and early stress urinary incontinence according to the Questionnaire for Urinary Incontinence Diagnosis (QUID) because of minimal tissue penetration… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- BPH, Prostate Obstruction
- What is being tested?
- Thulium fiber laser enucleation of the prostate and Holmium laser enucleation of the prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2020to 10 Oct 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- LUTS presence, proven by:
- IPSS questionnaire (Score >20);
- OR uroflowmetry result (Qmax <10 ml/s);
Who cannot join
- Prostate volume > 120 cc
- Prostate cancer on pathology;
- Urethral strictures;
- Bladder calculi;
- Prior prostate surgery;
- Neurogenic bladder dysfunction.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, 119991
About this study
Official title: Prospective Randomized Trial of Irritative Symptoms Severity Assessment After Holmium Laser Enucleation of the Prostate (HoLEP) Versus Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP).
The investigators hypothesize that the functional outcomes of both techniques are comparable. However, ThuFLEP might increase speed recovery of postoperative irritation and early stress urinary incontinence according to the Questionnaire for Urinary Incontinence Diagnosis (QUID) because of minimal tissue penetration depth of TFL.
Read the detailed description
Thulium fiber laser enucleation of the prostate (ThuFLEP) has already shown the outcomes comparable to OSP with better safety profile (lower blood loss compared to OSP) and shorter hospital stay. TFL has the efficacy and safety proven in comparative trials, being a promising rival for HoLEP. The main features of TFL distinguishing it from Ho:YAG is its wavelength of 1.94 µm (leading to about three-fold increase in water absorption and lesser penetration depth of <0.1 mm vs >0.2 mm in Ho:YAG). With identical average and peak powers of 100 W, the laser does not burst tissues, allowing for clean and precise cutting instead. Conversely, Ho:YAG's average power is about 100 W and its presumable peak power is around 10-15 kW. With such an outburst of energy, each pulse of Ho:YAG creates a large vapor bubble which ruptures the tissue. This may be a possible reason for increased irritative symptoms in early postoperative period after HoLEP comparing to ThuFLEP. But all in all, the probable causes for such postoperative symptoms remain unclear so far, despite the fact that absence of irritation and incontinence is ought to be one quality marker of "Pentafecta". According to the idea of high-power impact, probably, decreasing of HoLEP power will mitigate these problems. On the one hand, low-power HoLEP is feasible, safe and effective modality for symptomatic BPO. However, the results remain controversial and there is lack of LP-HoLEP application data nowadays. May be, with another option, for instance OSP or monopolar enucleation, it is possible to solve the issues. But the discussion of the past years demonstrates that the presence of early SUI is not only a problem of EEP, but also underreported in other approaches in relieving BPO secondary to BPH.
- Conditions
- BPH, Prostate Obstruction
- Being tested
- Thulium fiber laser enucleation of the prostate, Holmium laser enucleation of the prostate
- Keywords
- HoLEP, ThuFLEP, EEP, prostate enucleation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thulium fiber laser enucleation of the prostateProcedure or surgery
Also called ThuFLEP
enucleation of the BPH according to standard procedure protocol
Holmium laser enucleation of the prostateProcedure or surgery
Also called HoLEP
enucleation of the BPH according to standard procedure protocol
| Study group | Role | What they receive |
|---|---|---|
| ThuFLEP | Experimental | Patients who underwent thulium fiber enucleation of the prostate Receives: Procedure: Thulium fiber laser enucleation of the prostate |
| HoLEP | Active comparator | Patients who underwent holmium laser enucleation of the prostate Receives: Procedure: Holmium laser enucleation of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of urinary incontinence
Questionnaire for Urinary Incontinence Diagnosis (higher score means worse incontinence)
Measured: change from 1 week to 6 months after surgery
Secondary outcomes (6)
rate of intra- and perioperative adverse events
complications according to Clavien-Dindo classification (higher score means more severe complication)
Measured: 6 months follow up
surgery duration
lengths of the procedure
Measured: during surgery
hemoglobin drop
decrease of hemoglobin at the first day after surgery comparing to preoperative value
Measured: 1 day after surgery
catheter stay
lengths of catheterization
Measured: 1 week after surgery
hospitalization length
duration of staying at hospital after the surgery
Measured: 1 week after surgery
functional outcomes
IPSS (international prostate symptos score), QoL (quality of life), IIEF-5 (international index of erectile function) questionaries, Qmax
Measured: change from 3 to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Apr 2020
- Primary completion10 Jul 2021
- Study completion10 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342533
- Sponsor's protocol ID
- Sechenov-Ho_Vs_TFL-20
- Acronym
- PRISSA
- Status last verified
- Jul 2021
- First submitted
- 12 Mar 2020
- Last updated
- 22 Jul 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 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Irritative Symptoms Severity Assessment After Holmium Laser Enucleation of the Prostate (HoLEP) Versus Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP).
- ClinicalTrials.gov ID
- NCT04342533
- Acronym / sponsor ID
- PRISSA / Sechenov-Ho_Vs_TFL-20
- Conditions
- BPH, Prostate Obstruction
- Keywords
- HoLEP, ThuFLEP, EEP, prostate enucleation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 10 Jul 2021 (actual)
- Study completion
- 10 Oct 2021 (estimated)
- First posted
- 13 Apr 2020 (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 investigators hypothesize that the functional outcomes of both techniques are comparable. However, ThuFLEP might increase speed recovery of postoperative irritation and early stress urinary incontinence according to the Questionnaire for Urinary Incontinence Diagnosis (QUID) because of minimal tissue penetration depth of TFL.
Detailed description
Thulium fiber laser enucleation of the prostate (ThuFLEP) has already shown the outcomes comparable to OSP with better safety profile (lower blood loss compared to OSP) and shorter hospital stay. TFL has the efficacy and safety proven in comparative trials, being a promising rival for HoLEP. The main features of TFL distinguishing it from Ho:YAG is its wavelength of 1.94 µm (leading to about three-fold increase in water absorption and lesser penetration depth of <0.1 mm vs >0.2 mm in Ho:YAG). With identical average and peak powers of 100 W, the laser does not burst tissues, allowing for clean and precise cutting instead. Conversely, Ho:YAG's average power is about 100 W and its presumable peak power is around 10-15 kW. With such an outburst of energy, each pulse of Ho:YAG creates a large vapor bubble which ruptures the tissue. This may be a possible reason for increased irritative symptoms in early postoperative period after HoLEP comparing to ThuFLEP. But all in all, the probable causes for such postoperative symptoms remain unclear so far, despite the fact that absence of irritation and incontinence is ought to be one quality marker of "Pentafecta". According to the idea of high-power impact, probably, decreasing of HoLEP power will mitigate these problems. On the one hand, low-power HoLEP is feasible, safe and effective modality for symptomatic BPO. However, the results remain controversial and there is lack of LP-HoLEP application data nowadays. May be, with another option, for instance OSP or monopolar enucleation, it is possible to solve the issues. But the discussion of the past years demonstrates that the presence of early SUI is not only a problem of EEP, but also underreported in other approaches in relieving BPO secondary to BPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ThuFLEP | Experimental | Procedure: Thulium fiber laser enucleation of the prostatePatients who underwent thulium fiber enucleation of the prostate |
| HoLEP | Active comparator | Procedure: Holmium laser enucleation of the prostatePatients who underwent holmium laser enucleation of the prostate |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- LUTS presence, proven by:
Key exclusion criteria (6 listed)
- Prostate volume > 120 cc
- Prostate cancer on pathology;
- Urethral strictures;
- Bladder calculi;
- Prior prostate surgery;
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 |
|---|---|---|
| Thulium fiber laser enucleation of the prostateAlso: ThuFLEPenucleation of the BPH according to standard procedure protocol | Procedure or surgery | ThuFLEP |
| Holmium laser enucleation of the prostateAlso: HoLEPenucleation of the BPH according to standard procedure protocol | Procedure or surgery | HoLEP |
Primary outcome
severity of urinary incontinence
Time frame: change from 1 week to 6 months after surgery
Questionnaire for Urinary Incontinence Diagnosis (higher score means worse incontinence)
6 secondary outcomes
rate of intra- and perioperative adverse events
Time frame: 6 months follow up
surgery duration
Time frame: during surgery
hemoglobin drop
Time frame: 1 day after surgery
catheter stay
Time frame: 1 week after surgery
hospitalization length
Time frame: 1 week after surgery
functional outcomes
Time frame: change from 3 to 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thulium fiber laser enucleation of the prostate and Holmium laser enucleation of the prostate in people with BPH and Prostate Obstruction, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 3 inclusion and 6 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 22 Jul 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 Russia. 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?
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?
severity of urinary incontinence (time frame: change from 1 week to 6 months after surgery). 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 22 Jul 2021.