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NCT Number: NCT05574244

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CH Pays d'Aix, Aix-en-Provence, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Partial surgery preserving the prostatic apex

Procedure

Partial Endoscopic resection of prostate to conserve apex

Conventional endoscopic prostatic surgery

Procedure

Endoscopic resection of prostate.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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.

  7. 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

  8. Evaluation of complication rates

    Time frame: 1 month, 3 months, 6 months,12 months, and 36 months after surgery

    Re-intervention rate

Study contacts

Contact information is provided by the study sponsor or research team.

Grégoire ROBERT

CONTACT

[email protected]

05.57.82.06.87

Méric BEN BOUJEMA

CONTACT

[email protected]

05.57.82.06.87

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: PARTURP

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Oct 10, 2022
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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