Comparing two surgical methods for treating prostate enlargement while preserving ejaculation
Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction
This study is testing two different surgical methods for treating prostate enlargement in men to see which one helps improve urinary symptoms while also preserving the ability to ejaculate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 17 sites (Aix-en-Provence and 16 other locations) |
| Trial ID | NCT05574244 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of partial transurethral resection of the prostate with conventional transurethral resection for men suffering from benign prostatic hyperplasia. It focuses on improving lower urinary tract symptoms and preserving ejaculatory function, which is often compromised by traditional surgical methods. The trial employs a multicenter randomized design with single-blinded patients, assessing outcomes at six months post-surgery. Key measures include urinary flow, sexual life quality, and complication rates.
Who should consider this trial
Good fit: Ideal candidates are men over 40 with benign prostatic hyperplasia requiring surgical intervention and meeting specific clinical criteria.
Not a fit: Patients who have no pre-operative ejaculation or sexual activity, or those with certain medical histories such as prostate cancer, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for men by preserving sexual function while effectively treating urinary symptoms.
How similar studies have performed: Previous studies have shown promising results with modified surgical techniques aimed at preserving ejaculation, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Man over 40 years old * Indication of surgical management for BPH * Prostate volume ≥30 cc and ≤150 cc as evaluated by ultrasonography ( or an MRI if available) * IPSS score ≥12 * Qmax ≤15 ml/s * Affiliated to French national social security system * wish and be able to comply with planned visits * Able to express his consent * Signed informed consent form Exclusion Criteria: * Unwillingness to accept the treatment * No pre-operative ejaculation or sexuality * Neurological pathology responsible for micturition disorders * History of prostatic surgery * Stenosis of the urethra symptomatic * History of prostate cancer * History of radiotherapy or pelvic surgery * Patient refusing the principle of partial surgery * Life expectancy \<3 years * Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks. * Participation in another clinical study involving an investigational product within 1 month before study entry.
Where this trial is running
Aix-en-Provence and 16 other locations
- CH Pays d'Aix — Aix-en-Provence, France (Recruiting)
- CHU Angers — Angers, France (Recruiting)
- Centre Hospitalier Universitaire de Bordeaux — Bordeaux, France (Recruiting)
- CHU Mondor — Créteil, France (Withdrawn)
- Hôpital Claude Huriez — Lille, France (Withdrawn)
- CHU de Limoges — Limoges, France (Recruiting)
- Hôpital Nord Marseille — Marseille, France (Recruiting)
- Polyclinique Saint George — Nice, France (Recruiting)
- Hôpital cochin — Paris, France (Recruiting)
- Hôpital Prive Francheville — Périgueux, France (Recruiting)
- Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon Sud — Pierre-Bénite, France (Recruiting)
- Hôpital Privé des Côtes D'Armor — Plérin, France (Recruiting)
- CHU de Reims- Hôpital Robert Debré — Rennes, France (Recruiting)
- CHU de Rennes — Rennes, France (Recruiting)
- Clinique Pasteur — Toulouse, France (Withdrawn)
- CHRU Hôpitaux de tours — Tours, France (Withdrawn)
- Hopital Privé de Versailles, Clinique des Franciscaines — Versailles, France (Recruiting)
Study contacts
- Study coordinator: Grégoire ROBERT
- Email: gregoire.robert@chu-bordeaux.fr
- Phone: 05.57.82.06.87
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.