Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia (EMMECH)

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.

Study Overview

• Status: Terminated
• Conditions: Benign Prostatic Hyperplasia; Ejaculation; Prostate
• Intervention / Treatment: Procedure: Search retrograde ejaculation

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • CHU de Limoges
  • Nîmes, France, 30029
    • CHU de Nîmes
  • Toulouse, France, 31059
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Search retrograde ejaculation; Sperm count (spz) after orgasm achieved by masturbation will be measured, corresponding to the sum of spz collected in the ejaculate (E) and the first urine after orgasm (U). These measures will be made before surgery (E1 and U1) and after surgery (E2 and U2). The values E1, E2, U1 and U2 will be achieved by multiplying the concentration of spz per unit volume by the total volume of collection.

Procedure: Search retrograde ejaculation; Sperm count (spz) after orgasm achieved by masturbation will be measured, corresponding to the sum of spz collected in the ejaculate (E) and the first urine after orgasm (U). These measures will be made before surgery (E1 and U1) and after surgery (E2 and U2). The values E1, E2, U1 and U2 will be achieved by multiplying the concentration of spz per unit volume by the total volume of collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm count	Sperm count (spz) after orgasm achieved by masturbation will be measured, corresponding to the sum of spz collected in the ejaculate (E) and the first urine after orgasm (U). These measures will be made before surgery (E1 and U1) and after surgery (E2 and U2). The values E1, E2, U1 and U2 will be achieved by multiplying the concentration of spz per unit volume by the total volume of collection.	Baseline and 9 months
aspermia (A)	Aspermia is determined by the ratio of the difference of total spz between before surgery and after surgery on the number of spz before surgery	Baseline and 9 months
retrograde ejaculation (R)	retrograde ejaculation is determined by the difference in percentage of retrograde ejaculation between postoperative and preoperative	Baseline and 9 months
Evaluation of the coefficient C	A and R will be subtracted to obtain the coefficient C	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of surgery	determination of factors influencing the ejaculation changing mechanism after BPH surgery by evaluation of the coefficient C depending of type of surgery	9 months
Preoperative prostate volume	determination of factors influencing the ejaculation changing mechanism after BPH surgery by preoperative prostate volume measurement by ultrasound	9 months
Evaluation of the coefficient C depending on changing sexual symptoms relating to the change of sexuality questionary (IIEF15) before and after surgery	determination of factors influencing the ejaculation changing mechanism after BPH surgery by changing sexual symptoms relating to the change of sexuality questionary (IIEF15) before and after surgery	Baseline and 9 months
Changing in urinary output before and after surgery	determination of factors influencing the ejaculation changing mechanism after BPH surgery by changing in urinary output before and after surgery	Baseline and 9 months
Evaluation of urinary symptoms questionary (IPSS) before and after surgery	determination of factors influencing the ejaculation changing mechanism after BPH surgery by changing in urinary symptoms corresponding to the change in score in the evaluation of urinary symptoms questionary (IPSS) before and after surgery	Baseline and 9 months
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).	determination of factors influencing the ejaculation changing mechanism after BPH surgery by assessment of degree of resection	Baseline and 9 months

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Aurélien DESCAZEAUD, MD, Limoges Univerity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2016
• Primary Completion (Actual): June 11, 2018
• Study Completion (Actual): June 11, 2018

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: September 27, 2016
• First Posted (Estimate): September 28, 2016

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; Prostate; Ejaculation
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: I15028 (EMMECH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No