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)

April 8, 2026 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

336

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Aix-en-Provence, France
        • Recruiting
        • CH Pays d'Aix
        • Contact:
          • FOURMARIER Marc, Dr
      • Angers, France
        • Recruiting
        • CHU Angers
        • Contact:
          • LEBDAI Souhil, Dr
      • Bordeaux, France, 33000
      • Créteil, France
        • Withdrawn
        • CHU Mondor
      • Lille, France
        • Withdrawn
        • Hopital Claude Huriez
      • Limoges, France
        • Recruiting
        • CHU de Limoges
        • Contact:
          • DESCAZEAUD Aurélien, Pr
      • Marseille, France
        • Recruiting
        • Hôpital Nord Marseille
        • Contact:
          • BABOUDJIAN Michael, Dr
      • Nice, France
      • Paris, France
      • Pierre-Bénite, France
        • Recruiting
        • Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon Sud
        • Contact:
      • Plérin, France
        • Recruiting
        • Hôpital privé des Côtes d'Armor
        • Contact:
          • DELLA NEGRA Emmanuel, Dr
      • Périgueux, France
        • Recruiting
        • Hôpital Privé Francheville
        • Contact:
          • Mallet Richard, Dr
      • Rennes, France
      • Rennes, France
        • Recruiting
        • CHU de Reims- Hôpital Robert Debré
        • Contact:
          • TAHA Fayek
      • Toulouse, France
        • Withdrawn
        • Clinique Pasteur
      • Tours, France
        • Withdrawn
        • CHRU Hôpitaux de Tours
      • Versailles, France
        • Recruiting
        • Hopital Privé de Versailles, Clinique des Franciscaines
        • Contact:
          • Benchikh Amine, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months
Time Frame: 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).
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of ejaculation and global sexual life
Time Frame: 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
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

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
Evaluation of complication rates
Time Frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Complications based on Clavien Dindo classification
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
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
Evaluation of ejaculation and global sexual life
Time Frame: 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
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
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
Evaluation of lower urinary tract symptoms
Time Frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Qmax (non-inferiority test) not performed at 1 month
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
Re-intervention rate
1 month, 3 months, 6 months,12 months, and 36 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2022

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2019/57

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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