Clinical trial NCT02918227: Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia
Official title: Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate
Ejaculation
Benign Prostatic Hyperplasia
Keywords: Ejaculation
Benign Prostatic Hyperplasia
Prostate
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Every year in France, more than 60 000 people are operated for benign prostatic hyperplasia (BPH). This surgery is accompanied by a change or even a loss of ejaculations externalized what constitutes the main constraint for patients. Empirically, the investigators talk to the patient "retrograde ejaculation" to explain a possible loss of ejaculation. Yet the underlying mechanism of this modification or loss of ejaculation remains completely unknown. Yet the underlying mechanism of this modification or loss of ejaculation remains completely unknown. No study could not determine whether the predominant mechanism was a real retrograde ejaculation or aspermia. Moreover, technical changes are sometimes tempted to preserve antegrade ejaculation but no scientific rationale can not validate.

Detailed description: Every year in France, more than 60 000 people are operated for benign prostatic hyperplasia (BPH). This surgery is accompanied by a change or even a loss of ejaculations externalized what constitutes the main constraint for patients. Empirically, the investigators talk to the patient "retrograde ejaculation" to explain a possible loss of ejaculation. Yet the underlying mechanism of this modification or loss of ejaculation remains completely unknown. No study could not determine whether the predominant mechanism was a real retrograde ejaculation or aspermia. Moreover, technical changes are sometimes tempted to preserve antegrade ejaculation but no scientific rationale can not validate.

Eligibility criteria: Inclusion Criteria:

* Man, at least 18 years, which is scheduled for a BPH surgery
* Sexually active
* Measurement of Residual postvoid less than 6 months
* Patients accepting the constraints of the study
* Signed Consent
* Affiliate or beneficiary of social security system.

Exclusion Criteria:

* Patients unable to understand the study or to give consent
* Patients with known infertility
* Patients previously operated prostate
* Patients previously treated with a natural prostate treatment (radiotherapy, microwave, radio frequency, ultrasound)
* Patients with known urethral stenosis before surgery
* Patient with impaired preoperative in ejaculation
* Patient under guardianship or under judicial protection
* Patient subject to psychiatric care

Primary outcomes:
measure: Sperm count
timeFrame: Baseline and 9 months
measure: aspermia (A)
timeFrame: Baseline and 9 months
measure: retrograde ejaculation (R)
timeFrame: Baseline and 9 months
measure: Evaluation of the coefficient C
timeFrame: 9 months
Secondary outcomes:
measure: Type of surgery
timeFrame: 9 months
measure: Preoperative prostate volume
timeFrame: 9 months
measure: Evaluation of the coefficient C depending on changing sexual symptoms relating to the change of sexuality questionary (IIEF15) before and after surgery
timeFrame: Baseline and 9 months
measure: Changing in urinary output before and after surgery
timeFrame: Baseline and 9 months
measure: Evaluation of urinary symptoms questionary (IPSS) before and after surgery
timeFrame: Baseline and 9 months
measure: Degree of resection evaluated by pre/postoperative prostate volume ratio, ratio of prostatic specific antigen (PSA) preoperative / postoperative and measurement of the resected weight (or the number of joules used in case of laser vaporization).
timeFrame: Baseline and 9 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de LIMOGES
city: Nîmes
country: France
facility: CHU de Nîmes
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: Limoges Univerity Hospital
name: Aurélien DESCAZEAUD, MD
role: PRINCIPAL_INVESTIGATOR
References: