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

Benign Prostatic Hyperplasia Clinical Trial

— PARTURP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574244
• Other study ID #: CHUBX 2019/57
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2022
• Est. completion date: April 15, 2027

Study information

• Verified date: June 2023
• Source: University Hospital, Bordeaux
• Contact: Grégoire ROBERT
• Phone: 05.57.82.06.87
• Email: gregoire.robert[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: April 15, 2027
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Man over 40 years old

• Indication of surgical management for BPH

• Prostate volume =30 cc and =100 cc as evaluated by ultrasonography

• 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

• History of prostatic arterial embolisation

• Stenosis of the urethra

• 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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• Partial surgery preserving the prostatic apex
Partial Endoscopic resection of prostate to conserve apex
• Conventional endoscopic prostatic surgery
Endoscopic resection of prostate.

Locations

Country	Name	City	State
France	CH Pays d'Aix	Aix-en-Provence
France	CHU Angers	Angers
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	CHU Mondor	Créteil
France	Hôpital Claude Huriez	Lille
France	CHU de Limoges	Limoges
France	Polyclinique Saint George	Nice
France	Hôpital cochin	Paris
France	Hôpital Tenon	Paris
France	Hôpital Prive Francheville	Périgueux
France	Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon Sud	Pierre-Bénite
France	Hôpital Privé des Côtes D'Armor	Plérin
France	Clinique Pasteur	Toulouse
France	CHRU Hôpitaux de tours	Tours
France	Hopital Privé de Versailles, Clinique des Franciscaines	Versailles

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of ejaculation and global sexual life	MSHQ ejd= Male Sexual Health Questionnaire for Ejaculatory Dysfonction Scale score : [1-20] : a higher score mean that the subject have a ejaculatory dysfunction and sexual troubles	1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary	Evaluation of lower urinary tract symptoms	Urinary Symptom Profile (USP) : 1a+1b+1C [0-9]. A higher score mean that the subject have urinary leakage; 2+3+4+4bis+5+6+7 [0-21]. A higher score mean that the subject have voiding urgency; 8+9+10 [0-9]. A higher score mean that the subject have voiding problem	1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary	Evaluation of complication rates	Complications based on Clavien Dindo classification	1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary	Evaluation of ejaculation and global sexual life	IIEF-15 (including orgasmic function: questions 9 and 10), auto-questionnaire (superiority test)	1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary	Evaluation of ejaculation and global sexual life	DAN PPS-SEX= Danish Prostatic Symptom Score -Sexual Questions 1A And B are question about erectyl function Questions 2A, 2B, 3A and 3B are questions about ejaculatory function Questions 4A is a question about global sexual quality of life	1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary	Evaluation of lower urinary tract symptoms	IPSS = International Prostate Score Symptom Scale score [0-35]. The higher score mean that the subject have important lower urinary tract symptoms.	1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary	Evaluation of lower urinary tract symptoms	Qmax (non-inferiority test) not performed at 1 month	1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary	Evaluation of complication rates	Re-intervention rate	1 month, 3 months, 6 months,12 months, and 36 months after surgery