Urodynamic Evaluation of Disobstrucitve Power of Aquablation VS Laser Techniques

Benign Prostatic Hyperplasia (BPH) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03846700
• Other study ID #: 001
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2019
• Source: University of Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• aquablation
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
• holep
holmium laser enucleation of prostate
• pvp
photoselectivevaporization of prostate

Locations

Country	Name	City	State
Italy	University of Bari "Aldo Moro"	Bari

Sponsors (7)

Lead Sponsor	Collaborator
University of Bari	Francesco Di Modugno, Gaetano de Rienzo, Giuseppe Lucarelli, Marco Spilotros, Michele Battaglia, Pasquale Ditonno

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PSA	Evaluation of total-PSA variation in two groups	1, 3 and 6 months
Other	complications	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
Primary	BOOI variations	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	IPSS score	Evaluation of the IPSS score variations in two groups of patients,	1, 3 and 6 months
Secondary	Qmax	Evaluation of Qmax variations with uroflowmetry and post-voiding residue in two groups;	1, 3 and 6 months
Secondary	sexual satisfaction	Evaluation of sexual satisfaction by IIEF-5 survey and evaluation of presence of anejaculation in two groups;	1, 3 and 6 months