Clinical trial NCT06091618: Laser Vaporization of the Prostate: Comparing Between Ejaculatory Preserving and Non-ejaculatory Preserving Technique
Official title: Laser Vaporization of the Prostate: Comparative Study Between Ejaculatory Preserving and Non-ejaculatory Preserving Technique
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostatic Hyperplasia
Keywords: ejaculatory preserving
laser vaporization of the prostate
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 120
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

Detailed description: Benign prostate hyperplasia (BPH) is a histological diagnosis which is identified by non-malignant hyperplasia of prostatic tissue due to smooth muscle and epithelial cell proliferation in the prostate transition zone.

The prevalence of histologically diagnosed (BPH) increases from 8% in men aged 31 to 40 years old to 40-50% in men aged 51 to 60 years old. This increases to over 80% in men older than 80 years old.

Bladder outlet obstructions (BOO) are one of the major disorders in the aging male, The most common aetiology of BOO in elderly men above the age of 60 years is (BPH), but younger men (\< 50 years old) can also experience infra vesical obstruction from a small but obstructive prostate.

Ejaculation is one of the fundamental domains of male sexual function An almost inevitable adverse event of the conventional TURP is the loss of antegrade ejaculation, seen in 65%-80% of patients.

The use of alpha receptor antagonists is also known to cause a loss in antegrade ejaculation. Aside from peri- and postoperative morbidities, such as bleeding and TURP syndrome, the loss of ejaculation represents a major reason for the avoidance of surgical treatment. This is a particular issue among young people who hesitate to agree to the TURP procedure due to the fear of loss of ejaculation. Losing the ability to ejaculate often leads to a subsequent decrease in sexual pleasure, which has psychosocial implications but can also impact on aspects related to their cultural background, desire for children, and sexual life.

According to the current theory of ejaculation, the loss of antegrade ejaculation is attributed to the loss of bladder neck function after resection.

Even though TURP has a high success rate, the perioperative morbidity and operative safety specially in relation to bleeding pose serious concerns In addition to bleeding, retrograde ejaculation and TURP syndrome due to irrigant absorption are also relevant to intra and postoperative complications.

Despite technical advancements in TURP, blood transfusion rates are still 2 % to 7 %, TUR syndrome occurs in 2 %, stress urinary incontinence in 2 %, retrograde ejaculation in 65 % to 70.0%, urethral strictures in 4 %, bladder neck contractures in 4 % and early revision rates are 3 % to 5 %. These, along with prolonged catheterization time, advocate for alternatives to this treatment modality that offer similar clinical results but fewer complications

Laser vaporization of prostate is one of these methods. Lasers generate different effects in tissues, like coagulation and vaporization. Different types of laser like potassium-titanyl phosphate (KTP), holmium, diode and thulium are available. Of these, those gaining more popularity are the photoselective vaporization of the prostate (PVP) using the KTP laser, and holmium laser enucleation of the prostate (HOLEP).

The semiconductor diode laser is thought to be the best in relation to its haemostatic properties, but due to postoperative dysuria, pain, and storage urinary symptoms, it was less acceptable , A newly introduced diode laser, operating on the wavelength of 980 nm, is different in terms of its new fiber design, greater ablative properties of tissues, and efficient haemostasis due to its significant simultaneous absorption in water and Haemoglobin

The conventional technique of laser prostatectomy is traditionally performed with careful vaporization of apical tissue around the verumontanum.

To preserve the antegrade ejaculation, the paracollicular and the situated tissue, which is located 1 cm proximal to the verumontanum should not be vaporized. This is mainly related to the importance of the musculus ejaculatorius and verumontanum for ejaculation.

Based on this clearer understanding of the process of ejaculation, a new technique of trans urethral laser vaporization of the prostate , termed ejaculation-preserving technique was developed with the overarching aim of preserving antegrade ejaculation with comparable functional outcome for micturition parameters to regular technique.

Eligibility criteria: Inclusion criteria:

* 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

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.

Primary outcomes:
measure: compare between The Outcomes of conventional technique of laser prostatectomy versus the new ejaculatory sparing technique regarding semen volume
timeFrame: one year
measure: maximum flow rate of the urine after the procedure (Qmax )
timeFrame: one year
measure: international prostate symptoms score (IPSS)
timeFrame: one year
measure: post voiding residual urine
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
References:
citation: 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.
citation: 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.