BridgeMD
New treatment option for Benign Prostatic Hyperplasia
Official title 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
ClinicalTrials.gov ID: NCT05574244
What this study is testing
- What it's testing
- It has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (QoL). Ejaculatory dysfunction (EjD) is the most common side effect of surgical treatment of benign prostatic obstruction (BPO).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, men only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aix-en-Provence, France
- Angers, France
- Bordeaux, France
- Créteil, France
- Lille, France
- Limoges, France
- Marseille, France
- Nice, France
- Paris, France
- Périgueux, France
- Pierre-Bénite, France
- Plérin, France
- Rennes, France
- Toulouse, France
- Tours, France
- Versailles, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aix-en-Provence, France; Angers, France; Bordeaux, France; Créteil, France; Lille, France; Limoges, France and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.