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

NCT05574244 | Recruiting

• 1 other identifier: CHUBX 2019/57
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Lower Urinary Tract Symptoms; Transurethral resection of prostate; Partial Transurethral resection of prostate; quality of life; Ejaculation

Outcome Measures

Primary Outcomes (1)

• Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months

  the mean IPSS score measured at 6 months, to compare the efficacy of partial endoscopic resection versus complete endoscopic resection in improvement of lower urinary tract symptoms related to BPH. IPSS scores are categorised as 'asymptomatic' (0 points), 'mildly symptomatic' (1-7 points), 'moderately symptomatic' (8-19 points), and 'severely symptomatic' (20-35 points).

  6 months after surgery

Secondary Outcomes (8)

• Evaluation of ejaculation and global sexual life

  1 month, 3 months, 6 months,12 months, and 36 months after surgery

• Evaluation of lower urinary tract symptoms

  1 month, 3 months, 6 months,12 months, and 36 months after surgery

• Evaluation of complication rates

  1 month, 3 months, 6 months,12 months, and 36 months after surgery

• Evaluation of ejaculation and global sexual life

  1 month, 3 months, 6 months,12 months, and 36 months after surgery

• Evaluation of ejaculation and global sexual life

  1 month, 3 months, 6 months,12 months, and 36 months after surgery

Study Arms (2)

Conventional endoscopic prostatic surgery

EXPERIMENTAL

Endoscopic resection of prostate.

Procedure: Conventional endoscopic prostatic surgery

Partial surgery preserving the prostatic apex

EXPERIMENTAL

Patients randomised to the partial endoscopic resection group will undergo surgical treatment that preserves the apex area of the prostate (tissue located 1 cm around the veru montanum).

Procedure: Partial surgery preserving the prostatic apex

Interventions

Partial surgery preserving the prostatic apex PROCEDURE

Partial Endoscopic resection of prostate to conserve apex

Partial surgery preserving the prostatic apex

Conventional endoscopic prostatic surgery PROCEDURE

Endoscopic resection of prostate.

Conventional endoscopic prostatic surgery

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Man over 40 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify 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
• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (17)

CH Pays d'Aix

Aix-en-Provence, France

RECRUITING

CHU Angers

Angers, France

RECRUITING

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, 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

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Grégoire ROBERT

CONTACT

05.57.82.06.87; gregoire.robert@chu-bordeaux.fr

Méric BEN BOUJEMA

CONTACT

05.57.82.06.87; meric.ben-boujema@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: * The clinical research assistant will fill-out the electronic case report form (eCRF) "randomisation" page and perform the randomisation. The site will immediately provide the study identification number for the patient and the allocation group. * The clinical research assistant will print the result of the randomisation. The printed document will be placed in a sealed envelope that will be stored in the patient's file. * The surgeon will open the envelope in the operating theatre once the patient has been placed under general anaesthesia. To prevent breaking the blinding post-operatively, the complete or partial aspect of endoscopic resection will not be mentioned in the surgical report (the patient will be specifically informed of that particular point before signing the informed consent). The complete or partial aspect of surgery will be revealed to patients at the end of follow-up, and in case of any surgical problem (e.g. need for re-intervention) or consent withdrawal.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non inferiority Comparative single-blinded (patient) multicentre randomised clinical trial in two parallel groups: * Group 1: Conventional endoscopic prostatic surgery * Group 2: Partial surgery preserving the prostatic apex

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: October 10, 2022
• Study Start: September 29, 2022
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 9, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (17)