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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Partial surgery preserving the prostatic apex, Conventional endoscopic prostatic surgery.
- Who it may be relevant to
- Registry conditions: Benign Prostatic Hyperplasia. Basic parameters: from 40 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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). It has been considered for decades to be an inevitable consequence of restoring micturition comfort. EjD can have a substantial deleterious effect on the QoL of men with previously maintained regular sexual activity, inducing decreased orgasmic intensity and increased levels of anxiety and depression. A better understanding of the physiology of ejaculation has enabled the emergence of modified surgical techniques that aim to preserve antegrade ejaculation. Our hypothesis is that conservation of ejaculation can be achieved by modified surgical procedures without compromising functional outcomes.
Detailed description
The aim of this study is To compare the efficacy of partial trans urethral resection of the prostate versus conventional resection of the prostate in improvement of lower urinary tract symptoms related to benign prostatic hyperplasia at 6 months. The secondary objectives are to compare the impacts of partial prostatic endoscopic surgery versus conventional endoscopic surgery on ejaculatory function, lower urinary tract symptoms, Global sexual life, Urinary flow, complication related to the surgery and the rates of re-treatment.
Investigators use a non-inferiority comparative single blinded (patient) multicenter randomized clinical trial in two parallel groups (Conventional endoscopic prostatic surgery Vs Partial surgery preserving the prostatic apex.
Interventions
- Procedure Partial surgery preserving the prostatic apex
Partial Endoscopic resection of prostate to conserve apex - Procedure Conventional endoscopic prostatic surgery
Endoscopic resection of prostate.
Primary outcome measures
- Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months [Time frame: 6 months after surgery]
Secondary outcome measures (8)
- Evaluation of ejaculation and global sexual life [Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
- Evaluation of lower urinary tract symptoms [Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
- Evaluation of complication rates [Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
- Evaluation of ejaculation and global sexual life [Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
- Evaluation of ejaculation and global sexual life [Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
- Evaluation of lower urinary tract symptoms [Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
- Evaluation of lower urinary tract symptoms [Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
- Evaluation of complication rates [Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
France · 17 centers
- CH Pays d'Aix — Aix-en-Provence
- CHU Angers — Angers
- Centre Hospitalier Universitaire de Bordeaux — Bordeaux
- CHU Mondor — Créteil
- Hôpital Claude Huriez — Lille
- CHU de Limoges — Limoges
- Hôpital Nord Marseille — Marseille
- Polyclinique Saint George — Nice
- … and 9 more centers
Identifiers
NCT: NCT05574244 · CHUBX 2019/57