Comparing two techniques for laser treatment of prostate enlargement
Laser Vaporization of the Prostate: Comparative Study Between Ejaculatory Preserving and Non-ejaculatory Preserving Technique
This study is testing a new laser treatment for prostate enlargement to see if it can help men keep their ability to ejaculate while also improving their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 45 Years and up |
| Sex | Male |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06091618 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the outcomes of a conventional laser prostatectomy technique with a new ejaculatory preserving technique for treating benign prostatic hyperplasia (BPH). BPH is a common condition in older men that can lead to bladder outlet obstruction, significantly affecting quality of life. The study will evaluate the effectiveness and safety of both techniques, focusing on preserving the ability to ejaculate, which is often lost with traditional methods. Participants will be men over 45 years old with specific criteria related to their prostate health and sexual function.
Who should consider this trial
Good fit: Ideal candidates are men over 45 years old with a clinical diagnosis of bladder outlet obstruction and a desire to maintain ejaculation.
Not a fit: Patients with ejaculatory dysfunction, prostate cancer, or significant urinary tract issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a surgical option that preserves ejaculation for men undergoing treatment for BPH.
How similar studies have performed: Other studies have shown promising results with ejaculatory preserving techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Ain Shams University Hospital — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: kirolos N habib, MD
- Email: kirolos.nabil@med.asu.edu.eg
- Phone: 01220357684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.