- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03846700
Urodynamic Evaluation of Disobstrucitve Power of Aquablation VS Laser Techniques
Non Inferiority Clinical Randomized Trial Comparing Disobstrucitve Power in Patients With LUTS by BHP (Evaluated With Invasive Advanced Urodynamic Tests) That Underwent to Aquablation, Holep and PVP
in the last decade, lots of attemps have been done to identify new technologies able to reply the efficacy of gold standard technique for treating BPH, but with a better safety profile. The introduction of laser techniques allowed to reduce complication rates. Among these, considerable importance had Holep and PVP. Aquablation is a recent technique for LUTS treatment. It is minimally invasive, robot-assisted and ultrasound-guided to ablate the prostate in targeted way and in "heat-free" way. It works with high pression water jet. However, in literature informations about disobstructive capacity of minimally invasive techniques, evaluated with invasive urodynamic tests, are low.
The enrolled subjects will undergo surgical treatment with one of the techniques under study: Aquablation, HoLEP or PVP.
Outpatient visits will be performed at 1, 3 and 6 months after the surgical treatment. During the sixth month visit an invasive urodynamic examination will be performed
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
in the last decade, lots of attemps have been done to identify new technologies able to reply the efficacy of gold standard technique for treating BPH, but with a better safety profile. The introduction of laser techniques allowed to reduce complication rates. Among these, considerable importance had Holep and PVP. Aquablation is a recent technique for LUTS treatment. It is minimally invasive, robot-assisted and ultrasound-guided to ablate the prostate in targeted way and in "heat-free" way. It works with high pression water jet.
However, in literature informations about disobstructive capacity of minimally invasive techniques, evaluated with invasive urodynamic tests, are low.
In particular, about Aquablation, just in one trial is reported the reduction of BOOI, from 49 to 24 in 6 months after surgery, but this information is not associated with standard deviation and statistical significance.
Perreira-Carreia, J.A. et al, in 2012 reported a medium BOOI variation after 6 months by surgery, from 60 to 8,7 (p<0,001) even if procedure was conducted with laser 120 W.
In 2014 Know, O. and coll., reported BOOI reduction after Holep from 54,9 ± 30,2 to 3,4 ± 17,4 (p<0,001).
Actually, there are not trials comparing Aquablation with others mininvasive techniques to treat LUTS by BHP (in particular Holep and PVP).
This comparison is very interesting because of the specific benefits of each technique.
General and specific aims:
- non inferiority evaluation of the BOOI variations in patients with LUTS caused by cervico-urethral obstruction by BHP undergone to endoscopic surgery with aquablation versus patients operated with laser endoscopic surgery (primary goal);
- Evaluation of the IPSS score variations in two groups of patients,
- Evaluation of Qmax variations with uroflowmetry and post-voiding residue in two groups;
- Evaluation of sexual satisfaction by IIEF-5 survey and evaluation of presence of anejaculation in two groups;
- Evaluation of total-PSA variation in two groups;
- Evaluation of operative times, hospitalization and variations of haemoglobin and haematocrit value in two groups;
- Evaluation of appearing of side effects (grade 1 and ≥ 2 by Clavien-Dindo) occurred in perioperative period and at 1, 3 and 6 months after surgery;
Inclusion criteria:
- age ≥ 40 years and <90 years;
- moderate-to-severe lower urinary tract symptoms (IPSS ≥ 12)
- poor efficacy or tolerance to medical therapy for BPH
- transrectal ultrasound prostate volume between 30 and 120 ml
- ability to express written informed consent.
Exclusion criteria:
- previous surgical treatments for BPH
- indwelling bladder catheter or clean intermittent catheterization
- bladder stones
- severe detrusor hypocontractility (BCI <50) or detrusorial acontractility
- urethral strictures
- neurological bladder
- not replaceable anticoagulant or antiplatelet drugs for severe cardiological comorbidity
- bladder cancer;
- diagnosis or clinical suspicion of prostatic cancer;
Treatment The enrolled subjects will undergo surgical treatment with one of the techniques under study: Aquablation, HoLEP or PVP.
The study population will be divided into two cohorts based on prostate volume measured by transrectal ultrasound. Thereafter, patients with a prostate volume between 30 and 65 ml will be assigned to the aquablation arm or PVP arm, while patients with a prostate volume over 65 ml will be subjected to aquablation or HoLEP. The assignment to each of the arms will be randomized, using an on-line software for block randomization.
Follow-up:
Follow-up visits will be conducted by a blinded research team. Outpatient visits will be performed at 1, 3 and 6 months after the surgical treatment. During the sixth month visit an invasive urodynamic examination will be performed with cystomanometry and pressure-flow study.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bari, Italy, 70124
- Recruiting
- University of Bari "Aldo Moro"
-
Contact:
- Paolo PM Minafra, resident doctor
- Phone Number: 0039 3893472729
- Email: minafra.p@gmail.com
-
Contact:
- Francesco FDM Di Modugno, resident doctor
- Phone Number: 0039 3315667900
- Email: f.dimodugno1@virgilio.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- moderate-to-severe lower urinary tract symptoms (IPSS ≥ 12)
- poor efficacy or tolerance to medical therapy for BPH
- transrectal ultrasound prostate volume between 30 and 120 ml
- ability to express written informed consent.
Exclusion Criteria:
- previous surgical treatments for BPH
- indwelling bladder catheter or clean intermittent catheterization
- bladder stones
- severe detrusor hypocontractility (BCI <50) or detrusorial acontractility
- urethral strictures
- neurological bladder
- not replaceable anticoagulant or antiplatelet drugs for severe cardiological comorbidity
- bladder cancer;
- diagnosis or clinical suspicion of prostatic cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: aquablation
patients with prostatic volume included between 30 and 120 ml will be treated with water jet (aquablation).
patients with prostatic volume > 65 ml will be compared with holep arm and patients with prostatic volume included between 30 and 65 ml will be compared with pvp arm.
|
minimally invasive, robot-assisted and ultrasound-guided ablation of the prostate in targeted way and in "heat-free" way working by high pression water jet
|
ACTIVE_COMPARATOR: holep
patients with prostatic volume > 65 ml will be treated with holmium laser technique (Holep)
|
holmium laser enucleation of prostate
|
ACTIVE_COMPARATOR: pvp
patients with prostatic volume included between 30 and 65 ml will be treated with photoselective vaporization of prostate (pvp).
|
photoselectivevaporization of prostate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BOOI variations
Time Frame: 6 months
|
non inferiority evaluation of the BOOI variations in patients with LUTS caused by cervico-urethral obstruction by BHP undergone to endoscopic surgery with aquablation versus patients operated with laser endoscopic surgery
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IPSS score
Time Frame: 1, 3 and 6 months
|
Evaluation of the IPSS score variations in two groups of patients,
|
1, 3 and 6 months
|
Qmax
Time Frame: 1, 3 and 6 months
|
Evaluation of Qmax variations with uroflowmetry and post-voiding residue in two groups;
|
1, 3 and 6 months
|
sexual satisfaction
Time Frame: 1, 3 and 6 months
|
Evaluation of sexual satisfaction by IIEF-5 survey and evaluation of presence of anejaculation in two groups;
|
1, 3 and 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PSA
Time Frame: 1, 3 and 6 months
|
Evaluation of total-PSA variation in two groups
|
1, 3 and 6 months
|
complications
Time Frame: 1, 3 and 6 months
|
Evaluation of appearing of side effects (grade 1 and ≥ 2 by Clavien-Dindo) occurred in perioperative period and at 1, 3 and 6 months after surgery;
|
1, 3 and 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (NavyGHB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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