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

 Transurethral resection of the prostate (TURP) is considered the treatment of choice for
 patients suffering from benign prostatic hyperplasia (BPH) refractory to medical treatments
 or in patients with refractory urinary retention (1). It involves complete resection of the
 transitional zone of the prostate from the verumontanum to the bladder neck (2). Classical
 TURP has a high risk of ejaculatory dysfunction (65-70%) (2), and a 7% to 13% risk of
 bleeding that requires transfusion (3). To reduce these complications, newer technologies
 have been introduced to lower these associated risks, such as greenlight laser, Rezum, and
 Urolift (1).

 The dynamic of bladder outlet obstruction related to BPH adenoma site and distribution has
 not been completely elucidated. In a study that looked into this relationship, it suggested
 that the presence of intravesical prostatic protrusion (IPP) has been associated with the
 presence of prostatic adenoma with high sensitivity (95.4%), a high specificity (100%), and a
 high positive predictive value (100%), with the negative predictive value of (50%).
 Furthermore, the mean maximum flow rate (Qmax) in patients with only lateral lobe prostatic
 adenoma evaluated by cystoscopy was 16ml/s, while patients with middle lobe only adenoma have
 a flow max of 11.6 ml/s. When patients have both middle and lateral lobes, the mean Qmax was
 8.9 ml/sec (4). These findings highlight the major role of middle lobe adenoma and
 intravesical prostatic protrusion (which is usually an extension of the middle lobe), into
 the urodynamics of bladder outlet obstruction. Also, the intravesical prostatic extension has
 been suggested to cause a "ball-valve" effect that contributes significantly to the
 urodynamic bladder outlet obstruction (5). In a retrospective study, middle lobe only TURP
 for patients with prominent middle lobe adenoma and IPP of more than 10 mm, in patients with
 bothersome BPH symptoms or urinary retention, was associated with improvement in Qmax,
 Post-void residual and reduction of the international prostate symptoms score (IPSS), over a
 follow-up period up to 12 years. The urodynamic outcomes were comparable to traditional TURP
 results but with no change in ejaculatory bother scores pre and postoperatively. It also
 enabled including patients with larger prostate sizes (up to 178 g) that would require open
 prostatectomy or complete laser enucleation of the prostate (5).

 Rationale:

 Middle-lobe only TURP procedure has demonstrated durable, successful urodynamic outcomes in
 patients with significant bladder outlet obstruction caused by middle lobe with IPP of more
 than 10 mm, with no change in ejaculatory status after such procedure in retrospective
 fashion (5). No prospective studies have been done to document this effect. Also, the use of
 this procedure in patients with predominant meddle-lobe prostatic adenoma with minimal or no
 IPP has not been evaluated. Furthermore, the use of greenlight vaporization, which is proven
 to cause a significant reduction in blood loss, blood transfusion, and reduced hospital stay
 when compared to traditional TURP (6).

 This project will investigate the efficacy and durability of laser vaporization of the middle
 lobe only laser vaporization of prostate in patients with middle-lobe predominant prostatic
 adenoma occlusion, causing bothersome lower urinary tract symptoms (LUTS) or urinary
 retention that are refractory to medical treatment. The results of those patients will be
 compared to patients who will go complete PVP.

 Study Objectives:

 Primary objectives:

 -  To determine the difference in the incidence of inability to void that needs surgical
 intervention after a middle lobe only PVP compared to complete PVP.

 -  To determine the improvement in IPSS, Qmax, and post-void residual (PVR) in patients
 with bladder outlet obstruction caused by middle-lobe predominant prostatic adenoma
 leading to refractory bothersome LUTS or urinary retention, who will undergo middle lobe
 only greenlight photoselective vaporization of the prostate (PVP) or complete PVP in a
 prospective fashion.

 -  Compare the difference IPSS improvement in patients who underwent Middle lobe only PVP
 and patients who underwent complete PVP

 -  To evaluate the change in ejaculatory status before and after the procedure Male Sexual
 Health Questionnaire to Assess Ejaculatory Dysfunction (MSHQ-EjD) and compare the scores
 between the groups.

 Secondary Objectives:

 -  Subset analysis of the efficacy and change of treatment urodynamic outcomes based on
 prostate size, PSA, and the presence or absence of IPP and/or lateral lobe adenomas.

 -  Documenting of the need for additional treatment of interventions

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

 -  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

 -  Documentation of changes in erectile function using the Male Sexual Health Questionnaire
 (MSHQ)

 -  Determination of the need to be on BPH medication in both groups at each follow up
 visit.

 -  Documentation of the presence of dysuria and compare it between the groups.

 Investigational Plan:

 Overall Study Design and Plan: Description:

 -  We will conduct a prospective cohort study collecting patients with middle-lobe
 predominant prostatic adenoma causing BOO who failed medical treatment and need surgical
 intervention.

 -  Patients who tried medical treatment and have significant LUTS or urinary retention and
 require surgical intervention will require cystoscopy examination, PSA and ultrasound
 sizing of prostate as standard of care for this subset of patients.

 -  If the patient fits the inclusion and exclusion criteria for this study, the patient
 will be recruited, and he will sign an informed consent form if he agrees to participate
 in this study.

 -  We will also collect:

 1. Patient's demographic data, such as age, co-morbidities and BMI

 2. IPSS, MSHQ-EjD, and MSHQ scores.

 3. Pre-operative Q-max and PVR results.

 4. Pre-operative BPH and/or erectile dysfunction medical treatment, used prior to the
 surgical intervention.

 5. Pre-operative PSA, transabdominal ultrasound sizing of the prostate, serum
 creatinine and hemoglobin, urinalysis and culture, cystoscopy findings including
 the anatomical distribution of prostatic adenomas

 Procedure :

 -  Patient will undergo Middle-Lobe only PVP procedure. At the end of the vaporization of
 the middle lobe, the surgeon will evaluate prostatic urethra at its distal end to
 evaluate the opening created into the prostate.

 1. If the endoscopic view shows absence of obstructing prostatic adenoma, the
 procedure will be terminated and the patient will be included in the Middle lobe
 only group

 2. If the endoscopic view shows significant obstruction caused by lateral prostatic
 lobe, completion of lateral lobes vaporization will be carried out and the patient
 will be included in the complete PVP group

 -  The postoperative stay and perioperative complications will be documented, including the
 postoperative hemoglobin, and the need for transfusion.

 -  Medical treatment discontinuation: Alpha-blockers and 5-alpha reductase inhibitors will
 be stopped prior to discharge for all patients.

 -  Investigators will document the success of the tria-of-void (TOV) prior to discharge

 1. Patients with successful TOV, the first follow up will be in 2 months as a standard
 of care.

 2. Patients who will have a failed TOV prior to discharge will undergo the standard of
 care protocol for failed TOV used in standard PVP and TURP.

 2a. Patients will be discharged home with a Foley catheter 2b. We will book a second
 trial of void in the clinic within 5 to 7 days after surgery 2b1. If 2nd TOV is
 successful, patient will be followed 2 months after the procedure as the rest of
 patients 2b2. If the 2nd TOV failed, we will reinsert a foley catheter and we will
 arrange cystoscopy to reevaluate the prostatic urethra and the bladder followed by a 3rd
 TOV.

 2b2a. If successful TOV, patient will be back to the regular follow up. 2b2b. If there
 is a significant obstruction and failed TOV, a completion PVP will suggested as a
 standard of care.

 2b2c. If there is no blockage and a failed TOV, patient will be given the standard
 options of clean intermittent catheterization, indwelling suprapubic catheter, and
 indwelling urethral catheter.

 2b3. The data of patients who will fail TOV and their final outcomes will be collected
 and reported in the study.

 -  Post-operative follow-up protocol for included patients will be done at 2 months
 post-operatively, then at 6 months, then at 1 year then yearly, after. This is like
 standard of care in patients after PVP. A postoperative visit will document the
 following:

 1. IPSS, OABSS, MSHQ-EjD and MSHQ scores in each visit

 2. Symptoms improvement and overall satisfaction with the procedure in each visit as
 standard of care

 3. Recurrence of any LUTS as the standard of care

 4. Presence of urine culture-proven UTI The use of any BPH or OAB medications as the
 standard of care

 5. The presence or resolution of dysuria as standard of care

 6. Presence or absence of Incontinence, and type of incontinence, and treatment
 response to incontinence.

 7. Qmax and PVR

 8. PSA in the 2 months visit, then annually as per standard of care

 9. Serum creatinine level if indicated as standard of care

 10. Repeat cystoscopy and/or ultrasound if indicated as standard of care

 -  Researchers will collect patients' data and present initial results at 5 years and will
 continue collecting data after the initial reporting for future follow up studies.

 Number of Patients to be enrolled:

 Investigators will enroll at least 140 patients in the middle-lobe only PVP group and at
 least 140 patients in the complete PVP group.

 Study Duration:

 The study recruitment will continue until reaching the target sample size. Follow up the
 patients will continue until at least 5 years. Data will be collected beyond 5 years for
 possible future studies if the patient agrees up to 10 years.

 Study Conduct:

 Description of Activities:

 -  Research team will recruit patients from clinical encounters, including clinic,
 cystoscopy.

 -  If the patient meets the inclusion and exclusion criteria, the patient will be asked if
 he wants to participate in this study.

 -  If he agrees, the patient will sign the informed consent and fill the questionnaires.

 -  Patients will be allocated into either group based on intraoperative findings

 -  Post-operative care and follow up will be carried out based on the study protocol.

 Patient Discontinuation from the Study:

 If a patient wants to withdraw from the study after signing the consent form and before the
 procedure, the patient will not be included, and standard PVP procedure will be carried out
 as a standard of care.

 If a patient after completing the procedure wishes to withdraw from the study, we will
 discontinue his follow up but we will keep the data up to his discontinuation. the
 withdrawals will be counted, and we will ask the patient about the reason for withdrawal if
 he wishes, which will be documented in the research results. The follow up for such patients
 will continue as the standard of care.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  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

 -  Patients who have a large prostate (more than 120 g on trans-abdominal ultrasound
 prostate sizing).

 -  Patients who have renal impairment secondary to BPH

 -  Patients with proven or suspicion of prostate cancer based on clinical examination
 and/or PSA level

 -  Patients with refractory hematuria secondary to BPH

 -  Patients with urethral strictures

 -  Patients with bladder cancer

 -  Patients with history of pelvic radiotherapy