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

Primary Purpose

Prostatic Hyperplasia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
new technique of ejaculatory preserving laser prostatectomy
conventional technique of laser vaporization of the prostate
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring ejaculatory preserving, laser vaporization of the prostate

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

new technique of ejaculatory preserving laser vaporization prostatectomy

conventional technique laser vaporization prostatectomy

Arm Description

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.

non ejaculatory preserving laser vaporization of the prostate

Outcomes

Primary Outcome Measures

compare between The Outcomes of conventional technique of laser prostatectomy versus the new ejaculatory sparing technique regarding semen vloume
decreased,vanished or the same
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
international prostate symptoms scrore (IPSS)
Score: 1-7: Mild 8-19: Moderate 20-35: Severe Incomplete Emptying How often have you had the sensation of not emptying your bladder? 0 1 2 3 4 5 Frequency How often have you had to urinate less than every two hours? 0 1 2 3 4 5 Intermittency How often have you found you stopped and started again several times when you urinated? 0 1 2 3 4 5 Urgency How often have you found it difficult to postpone urination? 0 1 2 3 4 5 Weak Stream How often have you had a weak urinary stream? 0 1 2 3 4 5 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 Nocturia How many times did you typically get up at night to urinate? 0 1 2 3 4 5
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

Secondary Outcome Measures

Full Information

First Posted
September 26, 2023
Last Updated
October 14, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT06091618
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
November 27, 2023 (Anticipated)
Study Completion Date
December 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia
Keywords
ejaculatory preserving, laser vaporization of the prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
new technique of ejaculatory preserving laser vaporization prostatectomy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
conventional technique laser vaporization prostatectomy
Arm Type
Active Comparator
Arm Description
non ejaculatory preserving laser vaporization of the prostate
Intervention Type
Procedure
Intervention Name(s)
new technique of ejaculatory preserving laser prostatectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional technique of laser vaporization of the prostate
Intervention Description
conventional laser vaporization of the prostate
Primary Outcome Measure Information:
Title
compare between The Outcomes of conventional technique of laser prostatectomy versus the new ejaculatory sparing technique regarding semen vloume
Description
decreased,vanished or the same
Time Frame
one year
Title
maximum flow rate of the urine after the procedure (Qmax )
Description
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
Time Frame
one year
Title
international prostate symptoms scrore (IPSS)
Description
Score: 1-7: Mild 8-19: Moderate 20-35: Severe Incomplete Emptying How often have you had the sensation of not emptying your bladder? 0 1 2 3 4 5 Frequency How often have you had to urinate less than every two hours? 0 1 2 3 4 5 Intermittency How often have you found you stopped and started again several times when you urinated? 0 1 2 3 4 5 Urgency How often have you found it difficult to postpone urination? 0 1 2 3 4 5 Weak Stream How often have you had a weak urinary stream? 0 1 2 3 4 5 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 Nocturia How many times did you typically get up at night to urinate? 0 1 2 3 4 5
Time Frame
one year
Title
post voiding residual urine
Description
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
Time Frame
1 year

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
kirolos N habib, masters
Phone
01220357684
Email
kirolos.nabil@med.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed emam, doctorate
Phone
01228770965
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
ZIP/Postal Code
11741
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed emam, doctorate
Phone
01228770965

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34091741
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.
Results Reference
background
PubMed Identifier
32711008
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.
Results Reference
background

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

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