About this trial
The investigator aims to prospectively investigate the efficacy and durability of the middle lobe only versus traditional complete photoselective greenlight vaporization of the prostate in patients with prominent middle lobe. The investigator will select patients based on pre-op cystoscopy if patients have a prominent middle lobe to participate in this study. Researches will start to vaporize only the middle lobe then, at the end of this step, The investigator will look at the verumontanum into the prostatic fossa and determine if the patient is having adequate opened prostatic fossa or not. Patients with unsatisfactory opened fossa will have a complete PVP of lateral lobes, while patients with a satisfactory channel will not receive a complete PVP. Primary objectives of the study are to look into pre and post-operative uroflowmetry and post-void residual, International prostate symptoms scores, need of catheterization, and need for secondary interventions over five then ten years. Secondary objectives are to look into erectile and ejaculatory status using the Male Sexual Health Questionnaire (MSHQ) and MSHQ-EjD Short Form for Assessing EjD. Researchers will follow the patients at three months, six months, one year then yearly for five years then an extension to up to 10 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult males (18-year-old and more)
Suffering bothersome LUTS or urinary retention secondary to BPH
Cystoscopic examination documenting the predominant middle lobe prostatic adenoma that is considered to be the primary cause of BOO.
Disqualifiers
Patients neurogenic lower urinary tract dysfunction (Neurogenic Bladder)
Not competent to give consent and/or inability to provide answers to the questionnaire
Patient who refuse to participate in the study
Patients without a median lobe
Trial design
Parallel
Treatments tested in this trial
Middle lobe only Photoselective vaporization of the prostate (PVP)
Procedure/SurgeryMiddle lobe only Photoselective vaporization of the prostate (PVP) without vaporization of the lateral lobes
Complete PVP
Procedure/SurgeryTraditional Photoselective vaporization of the prostate PVP
Treatment groups
Trial outcomes
Primary outcomes
Inability to void
incidence of inability to void that needs surgical intervention after Middle lobe only PVP compared to complete PVP
IPSS
The difference in international prostate symptoms score (IPSS) pre and post interventions and compare it between groups
Qmax
The difference in Maximal flow rate (Qmax) pre and post interventions and compare it between groups
PVR
The difference in Post void residual pre and post interventions and compare it between groups
Secondary outcomes
Efficaciy of MLO based on prostate size, PSA, IPP and/or lateral lobes adenine
Subset analysis of the efficacy and change of treatment urodynamic outcomes based prostate size, PSA, and presence or absence of IPP and/or lateral lobe adenomas.
additional treatment
Documenting of the need for additional treatment of interventions
bleeding
The documentation of the blood loss and the need for blood transfusion
rate of patients with prominent middle lobe who needs MLO PVP
• Determination of the rate of patients that initially thought to have middle lobe predominant obstruction on pre-operative cystoscopy but needed complete PVP due to inadequate removal of adenoma after completing middle-lobe only PVP
Locations
Sponsors and contacts
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