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

Primary Purpose

Prostate, Ejaculation, Benign Prostatic Hyperplasia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Search retrograde ejaculation
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate focused on measuring Ejaculation, Benign Prostatic Hyperplasia, Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de LIMOGES
  • CHU de Nîmes
  • CHU de Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Search retrograde ejaculation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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
retrograde ejaculation (R)
retrograde ejaculation is determined by the difference in percentage of retrograde ejaculation between postoperative and preoperative
Evaluation of the coefficient C
A and R will be subtracted to obtain the coefficient C

Secondary Outcome Measures

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
Preoperative prostate volume
determination of factors influencing the ejaculation changing mechanism after BPH surgery by preoperative prostate volume measurement by ultrasound
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
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
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
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

Full Information

First Posted
September 27, 2016
Last Updated
June 4, 2019
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT02918227
Brief Title
Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia
Acronym
EMMECH
Official Title
Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Not enough patient
Study Start Date
December 8, 2016 (Actual)
Primary Completion Date
June 11, 2018 (Actual)
Study Completion Date
June 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate, Ejaculation, Benign Prostatic Hyperplasia
Keywords
Ejaculation, Benign Prostatic Hyperplasia, Prostate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Search retrograde ejaculation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Search retrograde ejaculation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sperm count
Description
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.
Time Frame
Baseline and 9 months
Title
aspermia (A)
Description
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
Time Frame
Baseline and 9 months
Title
retrograde ejaculation (R)
Description
retrograde ejaculation is determined by the difference in percentage of retrograde ejaculation between postoperative and preoperative
Time Frame
Baseline and 9 months
Title
Evaluation of the coefficient C
Description
A and R will be subtracted to obtain the coefficient C
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Type of surgery
Description
determination of factors influencing the ejaculation changing mechanism after BPH surgery by evaluation of the coefficient C depending of type of surgery
Time Frame
9 months
Title
Preoperative prostate volume
Description
determination of factors influencing the ejaculation changing mechanism after BPH surgery by preoperative prostate volume measurement by ultrasound
Time Frame
9 months
Title
Evaluation of the coefficient C depending on changing sexual symptoms relating to the change of sexuality questionary (IIEF15) before and after surgery
Description
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
Time Frame
Baseline and 9 months
Title
Changing in urinary output before and after surgery
Description
determination of factors influencing the ejaculation changing mechanism after BPH surgery by changing in urinary output before and after surgery
Time Frame
Baseline and 9 months
Title
Evaluation of urinary symptoms questionary (IPSS) before and after surgery
Description
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
Time Frame
Baseline and 9 months
Title
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).
Description
determination of factors influencing the ejaculation changing mechanism after BPH surgery by assessment of degree of resection
Time Frame
Baseline and 9 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélien DESCAZEAUD, MD
Organizational Affiliation
Limoges Univerity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de LIMOGES
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CHU de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia

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