PARTURP: 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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Recruiting

CT.gov ID

NCT05574244

Collaborator

(none)

336

Enrollment

Location

Arms

54.5

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Procedure: Partial surgery preserving the prostatic apex Procedure: Conventional endoscopic prostatic surgery	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

336 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 apexNon 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

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Other

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

Actual Study Start Date :

Sep 29, 2022

Anticipated Primary Completion Date :

Apr 15, 2023

Anticipated Study Completion Date :

Apr 15, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Conventional endoscopic prostatic surgery Endoscopic resection of prostate.	Procedure: Conventional endoscopic prostatic surgery Endoscopic resection of prostate.
Experimental: Partial surgery preserving the prostatic apex 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 Partial Endoscopic resection of prostate to conserve apex

Arm

Intervention/Treatment

Experimental: Conventional endoscopic prostatic surgery

Endoscopic resection of prostate.

Procedure: Conventional endoscopic prostatic surgery

Endoscopic resection of prostate.

Experimental: Partial surgery preserving the prostatic apex

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

Partial Endoscopic resection of prostate to conserve apex

Outcome Measures

Primary Outcome Measures

Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months [6 months after surgery]
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).

Secondary Outcome Measures

Evaluation of ejaculation and global sexual life [1 month, 3 months, 6 months,12 months, and 36 months after surgery]
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
Evaluation of lower urinary tract symptoms [1 month, 3 months, 6 months,12 months, and 36 months after surgery]
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
Evaluation of complication rates [1 month, 3 months, 6 months,12 months, and 36 months after surgery]
Complications based on Clavien Dindo classification
Evaluation of ejaculation and global sexual life [1 month, 3 months, 6 months,12 months, and 36 months after surgery]
IIEF-15 (including orgasmic function: questions 9 and 10), auto-questionnaire (superiority test)
Evaluation of ejaculation and global sexual life [1 month, 3 months, 6 months,12 months, and 36 months after surgery]
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
Evaluation of lower urinary tract symptoms [1 month, 3 months, 6 months,12 months, and 36 months after surgery]
IPSS = International Prostate Score Symptom Scale score [0-35]. The higher score mean that the subject have important lower urinary tract symptoms.
Evaluation of lower urinary tract symptoms [1 month, 3 months, 6 months,12 months, and 36 months after surgery]
Qmax (non-inferiority test) not performed at 1 month
Evaluation of complication rates [1 month, 3 months, 6 months,12 months, and 36 months after surgery]
Re-intervention rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.