ProstateEMMECHNCT02918227
Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia
A study testing Search retrograde ejaculation in people with Prostate and Ejaculation, run by University Hospital, Limoges at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate, Ejaculation, Benign Prostatic Hyperplasia
- What is being tested?
- Search retrograde ejaculation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Dec 2016to 11 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de LIMOGES
Limoges, 87042
CHU de Nîmes
Nîmes, 30029
CHU de Toulouse
Toulouse, 31059
About this study
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.
Read the 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.
- Conditions
- Prostate, Ejaculation, Benign Prostatic Hyperplasia
- Being tested
- Search retrograde ejaculation
- Keywords
- Ejaculation, Benign Prostatic Hyperplasia, Prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Search retrograde ejaculationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Search retrograde ejaculation | Experimental | 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. Receives: Procedure: Search retrograde ejaculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline and 9 months
retrograde ejaculation (R)
retrograde ejaculation is determined by the difference in percentage of retrograde ejaculation between postoperative and preoperative
Measured: Baseline and 9 months
Evaluation of the coefficient C
A and R will be subtracted to obtain the coefficient C
Measured: 9 months
Secondary outcomes (6)
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
Measured: 9 months
Preoperative prostate volume
determination of factors influencing the ejaculation changing mechanism after BPH surgery by preoperative prostate volume measurement by ultrasound
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start8 Dec 2016
- Primary completion11 Jun 2018
- Study completion11 Jun 2018
Why it stopped: Not enough patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstateStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien DESCAZEAUD, MD, Principal investigator, Limoges Univerity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918227
- Sponsor's protocol ID
- I15028 (EMMECH)
- Acronym
- EMMECH
- Status last verified
- Jun 2019
- First submitted
- 27 Sep 2016
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT02918227
- Acronym / sponsor ID
- EMMECH / I15028 (EMMECH)
- Conditions
- Prostate, Ejaculation, Benign Prostatic Hyperplasia
- Keywords
- Ejaculation, Benign Prostatic Hyperplasia, Prostate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patient
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 11 Jun 2018 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Search retrograde ejaculation | Experimental | Procedure: Search retrograde ejaculationSperm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Search retrograde ejaculationSperm 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 or surgery | Search retrograde ejaculation |
Primary outcome
Sperm count
Time frame: Baseline and 9 months
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)
Time frame: Baseline and 9 months
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)
Time frame: Baseline and 9 months
retrograde ejaculation is determined by the difference in percentage of retrograde ejaculation between postoperative and preoperative
Evaluation of the coefficient C
Time frame: 9 months
A and R will be subtracted to obtain the coefficient C
6 secondary outcomes
Type of surgery
Time frame: 9 months
Preoperative prostate volume
Time frame: 9 months
Evaluation of the coefficient C depending on changing sexual symptoms relating to the change of sexuality questionary (IIEF15) before and after surgery
Time frame: Baseline and 9 months
Changing in urinary output before and after surgery
Time frame: Baseline and 9 months
Evaluation of urinary symptoms questionary (IPSS) before and after surgery
Time frame: 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).
Time frame: Baseline and 9 months
Results and safety
The study was stopped early (reason given: Not enough patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélien DESCAZEAUD, MD principal investigator
Limoges Univerity Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Search retrograde ejaculation in people with Prostate and Ejaculation, run by University Hospital, Limoges at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough patient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm count (time frame: Baseline and 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019; AzTrials last refreshed its copy on 3 Nov 2026.