Urodynamic Evaluation of Disobstrucitve Power of Aquablation VS Laser Techniques

February 18, 2019 updated by: Paolo Minafra, University of Bari

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

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:

  1. 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);
  2. Evaluation of the IPSS score variations in two groups of patients,
  3. Evaluation of Qmax variations with uroflowmetry and post-voiding residue in two groups;
  4. Evaluation of sexual satisfaction by IIEF-5 survey and evaluation of presence of anejaculation in two groups;
  5. Evaluation of total-PSA variation in two groups;
  6. Evaluation of operative times, hospitalization and variations of haemoglobin and haematocrit value in two groups;
  7. 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

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bari, Italy, 70124
        • Recruiting
        • University of Bari "Aldo Moro"
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2019

Primary Completion (ANTICIPATED)

October 1, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

February 15, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (ACTUAL)

February 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 001 (NavyGHB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Benign Prostatic Hyperplasia (BPH)

Clinical Trials on aquablation

Subscribe