Benign Prostatic HyperplasiaNCT03264482
High Power Thulium Vaporization vs Transurethral Resection of the Prostate for Treatment of BPH
A study testing M-TURP and THUVAP in people with Benign Prostatic Hyperplasia, run by Mansoura University at 1 site in Egypt.
Trial summary
the investigators plan to test Thulium laser vaporization using high power ( 200w ) Front fire vaporization compared to standard M-TURP in reduction of LUTS secondary to BPH in a prospective randomized trial. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- M-TURP and THUVAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2017to 1 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients' age ≥50 years
- LUTS secondary to BOO due to BPH who failed medical treatment
- International prostate symptom scores (IPSS) >15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
- Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
- ASA (American society of anaesthesiologists) score ≤3.
- TRUS prostate size between 30-80 ml
Who cannot join
- Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
- Active urinary tract infection,
- Presence of active bladder pathology (within the last 2 years)
- Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
- Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
- Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) except for low-dose aspirin (e.g., 100 mg).
- Patient has had an acute myocardial infarction or open-heart surgery <180 days prior to the date of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Benign Prostatic Hyperplasia: High Power Thulium Laser Front Fire Vaporization VS Transurethral Resection - A Randomized Controlled Trial
the investigators plan to test Thulium laser vaporization using high power ( 200w ) Front fire vaporization compared to standard M-TURP in reduction of LUTS secondary to BPH in a prospective randomized trial.
Read the detailed description
When Lower Urinary Tract Symptoms (LUTS) are refractory to medical therapy and bothersome enough to warrant surgical intervention, transurethral resection of the prostate (TURP) has been the historical reference-standard procedures for prostate size between 30-80 ml for years.
Over the past decade, New minimally invasive surgical therapies (MIST), new medications, and novel combinations of medical therapies have expanded the number of treatment options ranging from watchful waiting to open surgery. The range of treatment options is as broad as the BPH spectrum of symptoms.
These treatment options include prostate vaporization, resection and enucleation using various energy sources , however the main theme for all these new procedures that they were done using physiological saline as an irrigant nullifying the risk of TUR syndrome.
One of the biggest changes in surgical treatment of BPH over the past 2 decades has been the introduction and use of lasers. Two-micron (Thulium) continuous-wave (CW) laser may have several advantages, including sufficient homeostasis with minimal thermal injury, more precise tissue incision, and operation in CW/pulsed modes. Pieces of the prostate are vaporized small enough to evacuate through the resectoscope sheath and use of a mechanical tissue morcellator is not required.
The introduction of the latest generation of the Thulium laser namely "200w laser " raises the expectations of the prostate vaporization.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- M-TURP, THUVAP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-TURPProcedure or surgery
endoscopic resection of the prostatic adenoma
THUVAPProcedure or surgery
vaporization of prostatic adenoma via THULIUM laser
| Study group | Role | What they receive |
|---|---|---|
| THUVAP | Active comparator | thulium vaporization Receives: Procedure: THUVAP |
| M-TURP | Active comparator | monopolar transurethral resection Receives: Procedure: M-TURP |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPSS score at 12 months .
international prostate symptom score (both voiding \& storage symptom subscores )
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 posted29 Aug 2017
- Study start20 May 2017
- Primary completion2 Dec 2018
- Study completion1 Dec 2020
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 Mansoura 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elshal, Mansoura University
- Investigators
- Ahmed M. Elshal, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264482
- Sponsor's protocol ID
- THUVAP VS M-TURP
- Status last verified
- Jul 2021
- First submitted
- 14 Aug 2017
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Benign Prostatic Hyperplasia: High Power Thulium Laser Front Fire Vaporization VS Transurethral Resection - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03264482
- Acronym / sponsor ID
- THUVAP VS M-TURP
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 29 Aug 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.
the investigators plan to test Thulium laser vaporization using high power ( 200w ) Front fire vaporization compared to standard M-TURP in reduction of LUTS secondary to BPH in a prospective randomized trial.
Detailed description
When Lower Urinary Tract Symptoms (LUTS) are refractory to medical therapy and bothersome enough to warrant surgical intervention, transurethral resection of the prostate (TURP) has been the historical reference-standard procedures for prostate size between 30-80 ml for years.
Over the past decade, New minimally invasive surgical therapies (MIST), new medications, and novel combinations of medical therapies have expanded the number of treatment options ranging from watchful waiting to open surgery. The range of treatment options is as broad as the BPH spectrum of symptoms.
These treatment options include prostate vaporization, resection and enucleation using various energy sources , however the main theme for all these new procedures that they were done using physiological saline as an irrigant nullifying the risk of TUR syndrome.
One of the biggest changes in surgical treatment of BPH over the past 2 decades has been the introduction and use of lasers. Two-micron (Thulium) continuous-wave (CW) laser may have several advantages, including sufficient homeostasis with minimal thermal injury, more precise tissue incision, and operation in CW/pulsed modes. Pieces of the prostate are vaporized small enough to evacuate through the resectoscope sheath and use of a mechanical tissue morcellator is not required.
The introduction of the latest generation of the Thulium laser namely "200w laser " raises the expectations of the prostate vaporization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THUVAP | Active comparator | Procedure: THUVAPthulium vaporization |
| M-TURP | Active comparator | Procedure: M-TURPmonopolar transurethral resection |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients' age ≥50 years
- LUTS secondary to BOO due to BPH who failed medical treatment
- International prostate symptom scores (IPSS) >15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
- Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
- ASA (American society of anaesthesiologists) score ≤3.
Key exclusion criteria (7 listed)
- Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
- Active urinary tract infection,
- Presence of active bladder pathology (within the last 2 years)
- Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
- Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
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 |
|---|---|---|
| M-TURPendoscopic resection of the prostatic adenoma | Procedure or surgery | M-TURP |
| THUVAPvaporization of prostatic adenoma via THULIUM laser | Procedure or surgery | THUVAP |
Primary outcome
IPSS score at 12 months .
Time frame: 12 months
international prostate symptom score (both voiding \& storage symptom subscores )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed M. Elshal, MD principal investigator
Mansoura 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 M-TURP and THUVAP in people with Benign Prostatic Hyperplasia, run by Mansoura University at 1 site in Egypt.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 27 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 Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IPSS score at 12 months . (time frame: 12 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 27 Jul 2021.