Clinical trial NCT03846700: Urodynamic Evaluation of Disobstrucitve Power of Aquablation VS Laser Techniques
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Lead sponsor: University of Bari
Sponsor class: OTHER
Collaborators: name: Gaetano de Rienzo
name: Pasquale Ditonno
name: Francesco Di Modugno
name: Michele Battaglia
name: Giuseppe Lucarelli
name: Marco Spilotros
First posted: 2019-02-20
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non inferiority, blinded, prospective, randomized clinical trial.
Primary purpose: TREATMENT

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: BOOI variations
timeFrame: 6 months
Secondary outcomes:
measure: IPSS score
timeFrame: 1, 3 and 6 months
measure: Qmax
timeFrame: 1, 3 and 6 months
measure: sexual satisfaction
timeFrame: 1, 3 and 6 months
Other outcomes:
measure: PSA
timeFrame: 1, 3 and 6 months
measure: complications
timeFrame: 1, 3 and 6 months
Locations:
city: Bari
country: Italy
facility: University of Bari "Aldo Moro"
Study officials:
References: