Laser Vaporization of the Prostate: Comparing Between Ejaculatory Preserving and Non-ejaculatory Preserving Technique

NCT06091618 | Unknown

• 1 other identifier: ejaculatory sparing laser turp
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The present work aimed to compare between The Outcomes of conventional technique of laser prostatectomy versus the new ejaculatory sparing technique .

Conditions

Prostatic Hyperplasia

Keywords

ejaculatory preserving; laser vaporization of the prostate

Outcome Measures

Primary Outcomes (4)

• compare between The Outcomes of conventional technique of laser prostatectomy versus the new ejaculatory sparing technique regarding semen volume

  decreased,vanished or the same

  one year

• maximum flow rate of the urine after the procedure (Qmax )

  maximum flow rate increased or decreased or the same Qmax Interpretation \* is higher than 15ml/sec Normal 10-15ml/sec Equivocal is lower than 10ml/sec Obstruction or weak detrusor

  one year

• international prostate symptoms score (IPSS)

  Score: 1-7: Mild 8-19: Moderate 20-35: Severe 1. Incomplete Emptying How often have you had the sensation of not emptying your bladder? 0 1 2 3 4 5 2. Frequency How often have you had to urinate less than every two hours? 0 1 2 3 4 5 3. Intermittency How often have you found you stopped and started again several times when you urinated? 0 1 2 3 4 5 4. Urgency How often have you found it difficult to postpone urination? 0 1 2 3 4 5 5. Weak Stream How often have you had a weak urinary stream? 0 1 2 3 4 5 6. Straining How often have you had to strain to start urination? 0 1 2 3 4 5 None 1 Time 2 Times 3 Times 4 Times 5 Times 7. Nocturia How many times did you typically get up at night to urinate? 0 1 2 3 4 5

  one year

• post voiding residual urine

  Post-void residual urine (PVR) is the amount of urine that remains in the bladder after urinating. It can be estimated by ultrasound or measured by catheterization1. A small amount of PVR is normal, but a high amount can indicate a urinary obstruction or other problems

  1 year

Study Arms (2)

new technique of ejaculatory preserving laser vaporization prostatectomy

ACTIVE COMPARATOR

laser will be employed to preform vaporization. The ejaculatory preserving procedure will be done in the following steps: 1. Setting a mark cut 1 cm proximal of the verumontanum as orientation. 2. Complete resection of the middle lobe to the abovementioned mark. 3. Vaporization of lateral lobes to the capsule and the ventral side to the level of the verumontanum with avoidance of paracollicular digging. 4. Circular resection of the internal bladder neck. 5. Apical resection utilizing the colliculus seminalis as a distal resection border and maintaining a 1cm safety area for preservation of ejaculation. 6. Total removal of prostate cuts and final check to confirm that there are no obstructive components.

Procedure: new technique of ejaculatory preserving laser prostatectomy

conventional technique laser vaporization prostatectomy

ACTIVE COMPARATOR

non ejaculatory preserving laser vaporization of the prostate

Procedure: conventional technique of laser vaporization of the prostate

Interventions

new technique of ejaculatory preserving laser prostatectomy PROCEDURE

laser will be employed to preform vaporization. The ejaculatory preserving procedure will be done in the following steps: Setting a mark cut 1 cm proximal of the verumontanum as orientation. Complete resection of the middle lobe to the abovementioned mark. Vaporization of lateral lobes to the capsule and the ventral side to the level of the verumontanum with avoidance of paracollicular digging. Circular resection of the internal bladder neck. Apical resection utilizing the colliculus seminalis as a distal resection border and maintaining a 1cm safety area for preservation of ejaculation. Total removal of prostate cuts and final check to confirm that there are no obstructive components.

new technique of ejaculatory preserving laser vaporization prostatectomy

conventional technique of laser vaporization of the prostate PROCEDURE

conventional laser vaporization of the prostate

conventional technique laser vaporization prostatectomy

Eligibility Criteria

• Age: 45 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>45 years old, clinical diagnosis of BOO by medical history and physical examination (including digital rectal examination)
• International prostate symptoms score (IPSS) \>14 points
• Normal PSA (PSA\<4 ng / ml or free/ total PSA \>0.25)
• Prostate size \< 80 gm
• Men with recurrent urinary retention (drug-refractory), urinary infection, or haematuria who had failed standard medical therapy (alpha-blockers, 5-alpha reductive inhibitors)
• Patients were also required to have an active and healthy sexual life, the ability to ejaculate and a desire to preserve ejaculation

You may not qualify if:

• Major psychiatric and somatic diseases and the use of drugs that affect sexual function
• Patients with ejaculatory dysfunction or no ejaculation
• Patients with documented or suspected prostate cancer
• Patients with neurogenic bladder, voiding dysfunction, urethral strictures, and malignancies of the upper or lower urinary tract,
• Prostates sized more than 80 CC, severe comorbidities or high surgical risk patients.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, 11741, Egypt

RECRUITING

Related Publications (2)

• Elshazly M, Sultan S, Shaban M, Zanaty F. Evaluation of a novel technique of bladder neck and supramontanal sparing ejaculatory preserving transurethral prostatectomy. World J Urol. 2021 Nov;39(11):4215-4219. doi: 10.1007/s00345-021-03752-z. Epub 2021 Jun 6.

  PMID: 34091741 BACKGROUND

• Brant A, Cho A, Posada Calderon L, Te A, Kashanian J, Chughtai B. Ejaculatory Hood-Sparing Vaporization of the Prostate and Its Impact on Erectile, Ejaculatory, and Sexual Function. Urology. 2020 Oct;144:177-181. doi: 10.1016/j.urology.2020.06.072. Epub 2020 Jul 23.

  PMID: 32711008 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

kirolos N habib, MD

CONTACT

01220357684; kirolos.nabil@med.asu.edu.eg

Ahmed Emam, PHD

CONTACT

01228770965

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized clinical study. Exclusion criteria * Major psychiatric and somatic diseases and the use of drugs that affect sexual function * Patients with ejaculatory dysfunction or no ejaculation * Patients with documented or suspected prostate cancer * Patients with neurogenic bladder, voiding dysfunction, urethral strictures, and malignancies of the upper or lower urinary tract, * Prostates sized more than 80 CC, severe comorbidities or high surgical risk patients.

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 19, 2023
• Study Start: August 1, 2022
• Primary Completion: March 27, 2024
• Study Completion: April 27, 2024
• Last Updated: March 20, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)