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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unwillingness to accept the treatment

No pre-operative ejaculation or sexuality

Neurological pathology responsible for micturition disorders

History of prostatic surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Partial surgery preserving the prostatic apex

    Procedure/Surgery

    Partial Endoscopic resection of prostate to conserve apex

  • Conventional endoscopic prostatic surgery

    Procedure/Surgery

    Endoscopic resection of prostate.

Treatment groups

336 Participants
are divided into 2 treatment groups
Group A: Conventional endoscopic prostatic surgeryExperimental treatment 1 intervention
Group B: Partial surgery preserving the prostatic apexExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
6 months after surgery

Secondary outcomes

1

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

Time frame
1 month, 3 months, 6 months,12 months, and 36 months after surgery
2

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

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

Evaluation of complication rates

Complications based on Clavien Dindo classification

Time frame
1 month, 3 months, 6 months,12 months, and 36 months after surgery
4

Evaluation of ejaculation and global sexual life

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

Other outcomes

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