Benign Prostatic Hyperplasia Clinical Trial
Official title:
Green Light Laser (XPS) Photoselective Vaporization of the Prostate (PVP) Versus Bipolar Transurethral Vaporization (B.TUVP) of the Prostate for Treatment of Small to Moderate Sized Benign Prostate Hyperplasia: A Randomized Study
Verified date | June 2019 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Urology and Nephrology Center | Mansoura | Aldakahlia |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
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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