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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02283684
Other study ID # Mans-2014-03
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2014
Est. completion date February 2018

Study information

Verified date June 2019
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight PVP/XPS, it seems to be a real contender in the world of MIS. Contenders of Greenlight laser technology includes bipolar as well as Holmium laser technology.

In this study the investigators planned to test the Greenlight (532-nm) laser PVP using (XPS) 180W system compared to bipolar electro-vaporization, in reduction of LUTS secondary to small to moderate sized BPH in a prospective randomized trial.


Description:

Patients with LUTS due to BPH seen through the outpatient prostate clinic in the Mansoura UNC were assessed to evaluate if the patient is eligible to the study inclusion criteria. Patients who are meeting these criteria were asked to participate in this randomized comparative study and were provided with an informed consent form. Study participants were enrolled and randomized, and the appropriate scheduled procedures were performed.

Preoperatively, all patients were thoroughly evaluated by medical history and physical exam, digital rectal exam (DRE), prostate specific antigen (PSA), urinalysis and urine culture, international index of prostate symptom score (IPSS), Quality of Life (QOL), transrectal ultrasound (TRUS) measurement of prostatic volume and biopsy whenever indicated, measurement of post-void residual assessment (PVR), and maximum urinary flow rate (Qmax). Preoperative flexible urethrocystoscopy was done when hematuria was the presenting symptom.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date February 2018
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility Inclusion Criteria:

1. Patients' age =50 years

2. LUTS secondary to BOO due to BPH who failed medical treatment

3. International prostate symptom scores (IPSS) >15 and bother score (QOL) = 3 (according to IPSS question 8)

4. Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.

5. ASA (American society of anaesthesiologists) score =3.

6. TRUS prostate size (from 30 to 80ml)

Exclusion Criteria:

1. Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease

2. Active urinary tract infection,

3. Presence of active bladder cancer (within the last 2 years)

4. Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.

Study Design


Intervention

Procedure:
Greenlight laser PVP
Vaporization of the prostate adenoma using 532nm laser with 180W XPS system using Moxy fiber
Bipolar TUVP
Bipolar energy is used for generation of plasma that ends up by vaporization of the prostate adenoma

Locations

Country Name City State
Egypt Urology and Nephrology Center Mansoura Aldakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary IPSS change change in the symptoms score over two years post procedure two years
Secondary Reoperation rate need for reintervention post procedure 4 years
Secondary Q.max maximal urine flow rate 2 years
Secondary biopsy clinicopathological outcome one month
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