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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 (PARTURP)

Primary Purpose

Benign Prostatic Hyperplasia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Partial surgery preserving the prostatic apex
Conventional endoscopic prostatic surgery
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Benign Prostatic Hyperplasia focused on measuring Lower Urinary Tract Symptoms, Transurethral resection of prostate, Partial Transurethral resection of prostate, quality of life, Ejaculation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • CH Pays d'Aix
  • CHU AngersRecruiting
  • Centre Hospitalier Universitaire de BordeauxRecruiting
  • CHU MondorRecruiting
  • Hôpital Claude Huriez
  • CHU de LimogesRecruiting
  • Polyclinique Saint GeorgeRecruiting
  • Hôpital cochinRecruiting
  • Hôpital Tenon
  • Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon SudRecruiting
  • Hôpital Privé des Côtes D'ArmorRecruiting
  • Hôpital Prive FranchevilleRecruiting
  • Clinique Pasteur
  • CHRU Hôpitaux de tours
  • Hopital Privé de Versailles, Clinique des FranciscainesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional endoscopic prostatic surgery

Partial surgery preserving the prostatic apex

Arm Description

Endoscopic resection of prostate.

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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
Evaluation of complication rates
Complications based on Clavien Dindo classification
Evaluation of ejaculation and global sexual life
IIEF-15 (including orgasmic function: questions 9 and 10), auto-questionnaire (superiority test)
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
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.
Evaluation of lower urinary tract symptoms
Qmax (non-inferiority test) not performed at 1 month
Evaluation of complication rates
Re-intervention rate

Full Information

First Posted
September 13, 2022
Last Updated
June 7, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT05574244
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2022 (Actual)
Primary Completion Date
March 29, 2024 (Anticipated)
Study Completion Date
April 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Lower Urinary Tract Symptoms, Transurethral resection of prostate, Partial Transurethral resection of prostate, quality of life, Ejaculation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 apex
Masking
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.
Allocation
Randomized
Enrollment
336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional endoscopic prostatic surgery
Arm Type
Experimental
Arm Description
Endoscopic resection of prostate.
Arm Title
Partial surgery preserving the prostatic apex
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Partial surgery preserving the prostatic apex
Intervention Description
Partial Endoscopic resection of prostate to conserve apex
Intervention Type
Procedure
Intervention Name(s)
Conventional endoscopic prostatic surgery
Intervention Description
Endoscopic resection of prostate.
Primary Outcome Measure Information:
Title
Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months
Description
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).
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Evaluation of ejaculation and global sexual life
Description
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
Time Frame
1 month, 3 months, 6 months,12 months, and 36 months after surgery
Title
Evaluation of lower urinary tract symptoms
Description
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
Time Frame
1 month, 3 months, 6 months,12 months, and 36 months after surgery
Title
Evaluation of complication rates
Description
Complications based on Clavien Dindo classification
Time Frame
1 month, 3 months, 6 months,12 months, and 36 months after surgery
Title
Evaluation of ejaculation and global sexual life
Description
IIEF-15 (including orgasmic function: questions 9 and 10), auto-questionnaire (superiority test)
Time Frame
1 month, 3 months, 6 months,12 months, and 36 months after surgery
Title
Evaluation of ejaculation and global sexual life
Description
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
Time Frame
1 month, 3 months, 6 months,12 months, and 36 months after surgery
Title
Evaluation of lower urinary tract symptoms
Description
IPSS = International Prostate Score Symptom Scale score [0-35]. The higher score mean that the subject have important lower urinary tract symptoms.
Time Frame
1 month, 3 months, 6 months,12 months, and 36 months after surgery
Title
Evaluation of lower urinary tract symptoms
Description
Qmax (non-inferiority test) not performed at 1 month
Time Frame
1 month, 3 months, 6 months,12 months, and 36 months after surgery
Title
Evaluation of complication rates
Description
Re-intervention rate
Time Frame
1 month, 3 months, 6 months,12 months, and 36 months after surgery

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Man over 40 years old
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grégoire ROBERT
Phone
05.57.82.06.87
Email
gregoire.robert@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Méric BEN BOUJEMA
Phone
05.57.82.06.87
Email
meric.ben-boujema@chu-bordeaux.fr
Facility Information:
Facility Name
CH Pays d'Aix
City
Aix-en-Provence
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FOURMARIER Marc, Dr
Facility Name
CHU Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LEBDAI Souhil, Dr
Facility Name
Centre Hospitalier Universitaire de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire ROBERT
Phone
05.57.82.06.87
Email
gregoire.robert@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Méric BEN BOUJEMA
Phone
05.57.82.06.87
Email
meric.ben-boujema@chu-bordeaux.fr
Facility Name
CHU Mondor
City
Créteil
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingels Alexandre, Dr
Facility Name
Hôpital Claude Huriez
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
OLIVIER Jonathan, Dr
Facility Name
CHU de Limoges
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DESCAZEAUD Aurélien, Pr
Facility Name
Polyclinique Saint George
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROUSCOFF Yohan, Dr
Email
yohann.ouscoff@clinique-saint-george.com
Facility Name
Hôpital cochin
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BARY DELONGCHAMPS Nicolas, Pr
Email
nicolas.barry-delongchamps@aphp.fr
Facility Name
Hôpital Tenon
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doizi Steeve, Dr
Email
steeve.doizi@aphp.fr
Facility Name
Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruffion Alain, Pr
Email
alain.ruffion@chu-lyon.fr
Facility Name
Hôpital Privé des Côtes D'Armor
City
Plérin
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DELLA NEGRA Emmanuel, Dr
Facility Name
Hôpital Prive Francheville
City
Périgueux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mallet Richard, Dr
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Misrai Vincent, Dr
Facility Name
CHRU Hôpitaux de tours
City
Tours
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruyere Franck, Pr
Facility Name
Hopital Privé de Versailles, Clinique des Franciscaines
City
Versailles
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benchikh Amine, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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