Urodynamic Evaluation of Disobstrucitve Power of Aquablation VS Laser Techniques

NCT03846700 | Unknown FDA Device

• 1 other identifier: 001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• IPSS score

  1, 3 and 6 months

• Qmax

  1, 3 and 6 months

• sexual satisfaction

  1, 3 and 6 months

Other Outcomes (2)

• PSA

  1, 3 and 6 months

• complications

  1, 3 and 6 months

Study Arms (3)

aquablation

EXPERIMENTAL

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.

Device: aquablation

holep

ACTIVE COMPARATOR

patients with prostatic volume \> 65 ml will be treated with holmium laser technique (Holep)

Device: holep

pvp

ACTIVE COMPARATOR

patients with prostatic volume included between 30 and 65 ml will be treated with photoselective vaporization of prostate (pvp).

Device: pvp

Interventions

aquablation DEVICE

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

aquablation

holep DEVICE

holmium laser enucleation of prostate

holep

pvp DEVICE

photoselectivevaporization of prostate

pvp

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bari: lead
• Gaetano de Rienzo: collaborator
• Pasquale Ditonno: collaborator
• Francesco Di Modugno: collaborator
• Michele Battaglia: collaborator
• Giuseppe Lucarelli: collaborator
• Marco Spilotros: collaborator

Study Sites (1)

University of Bari "Aldo Moro"

Bari, 70124, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Aquablation

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Model Details: non inferiority, blinded, prospective, randomized clinical trial.

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 20, 2019
• Study Start: March 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: December 31, 2019
• Last Updated: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)