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Prostatic HyperplasiaNCT06091618

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

A study testing new technique of ejaculatory preserving laser prostatectomy and conventional technique of laser vaporization of the prostate in people with Prostatic Hyperplasia, run by Ain Shams University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The present work aimed to compare between The Outcomes of conventional technique of laser prostatectomy versus the new ejaculatory sparing technique . Read more about this study

Who is it for?
Ages 45 years and older, men only
Conditions the study is for
Prostatic Hyperplasia
What is being tested?
new technique of ejaculatory preserving laser prostatectomy and conventional technique of laser vaporization of the prostate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteEgypt
Study dates
1 Aug 2022to 27 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

kirolos N habib, MD contact

01220357684

kirolos.nabil@med.asu.edu.eg

Ahmed Emam, PHD contact

01228770965

Egypt1 site, 1 recruiting
  • Ain Shams University Hospital

    Cairo, 11741

    ahmed emam, doctorate, 01228770965

    Recruiting

Other trials in Egypt

About this study

Official title: Laser Vaporization of the Prostate: Comparative Study Between Ejaculatory Preserving and Non-ejaculatory Preserving Technique

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

Read the 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.

Being tested
new technique of ejaculatory preserving laser prostatectomy, conventional technique of laser vaporization of the prostate
Keywords
ejaculatory preserving, laser vaporization of the prostate
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • new technique of ejaculatory preserving laser prostatectomyProcedure or surgery

    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.

  • conventional technique of laser vaporization of the prostateProcedure or surgery

    conventional laser vaporization of the prostate

Study groups in NCT06091618
Study groupRoleWhat they receive
new technique of ejaculatory preserving laser vaporization prostatectomyActive comparatorlaser 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.
Receives: Procedure: new technique of ejaculatory preserving laser prostatectomy
conventional technique laser vaporization prostatectomyActive comparatornon ejaculatory preserving laser vaporization of the prostate
Receives: Procedure: conventional technique of laser vaporization of the prostate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    decreased,vanished or the same

    Measured: one year

  2. 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

    Measured: one year

  3. 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

    Measured: one year

  4. 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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2023
  2. Study start1 Aug 2022
  3. Primary completion27 Mar 2024 (estimated)
  4. Study completion27 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06091618
Sponsor's protocol ID
ejaculatory sparing laser turp
Status last verified
Sep 2023
First submitted
26 Sep 2023
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34091741
  • 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.

    PubMed 32711008

Questions about this trial

What is this clinical trial studying?

A study testing new technique of ejaculatory preserving laser prostatectomy and conventional technique of laser vaporization of the prostate in people with Prostatic Hyperplasia, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact kirolos N habib, MD (01220357684, kirolos.nabil@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

compare between The Outcomes of conventional technique of laser prostatectomy versus the new ejaculatory sparing technique regarding semen volume (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06091618, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

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