Middle Lobe Only Laser Vaporization or Total Prostate Vaporization of the Prostate, Prospective Cohort Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-100
SponsorJewish General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Middle lobe only Photoselective vaporization of the prostate (PVP)

    Procedure/Surgery

    Middle lobe only Photoselective vaporization of the prostate (PVP) without vaporization of the lateral lobes

  • Complete PVP

    Procedure/Surgery

    Traditional Photoselective vaporization of the prostate PVP

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Prominent middle lobe BPH satisfactory channel after MLO PVPExperimental treatment 1 intervention
Group B: Prominent middle lobe BPH unsatisfactory channel after MLO PVPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Inability to void

incidence of inability to void that needs surgical intervention after Middle lobe only PVP compared to complete PVP

Time frame
3 months
2

IPSS

The difference in international prostate symptoms score (IPSS) pre and post interventions and compare it between groups

Time frame
3 months to 5 years
3

Qmax

The difference in Maximal flow rate (Qmax) pre and post interventions and compare it between groups

Time frame
3 months to 5 years
4

PVR

The difference in Post void residual pre and post interventions and compare it between groups

Time frame
3 months to 5

Secondary outcomes

1

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.

Time frame
3 months to 5 years
2

additional treatment

Documenting of the need for additional treatment of interventions

Time frame
3 months to 5 years
3

bleeding

The documentation of the blood loss and the need for blood transfusion

Time frame
3 months
4

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

Time frame
3 months to 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: