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Trial record 12 of 58 for:    Recruiting, Not yet recruiting, Available Studies | "Prostatic Hyperplasia"

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

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ClinicalTrials.gov Identifier: NCT02918227
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

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.

Condition or disease Intervention/treatment Phase
Prostate Ejaculation Benign Prostatic Hyperplasia Procedure: Search retrograde ejaculation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia
Actual Study Start Date : December 8, 2016
Estimated Primary Completion Date : June 8, 2019
Estimated Study Completion Date : December 8, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. Evaluation of the coefficient C [ Time Frame: 9 months ]
    A and R will be subtracted to obtain the coefficient C


Secondary Outcome Measures :
  1. Type of surgery [ Time Frame: 9 months ]
    determination of factors influencing the ejaculation changing mechanism after BPH surgery by evaluation of the coefficient C depending of type of surgery

  2. Preoperative prostate volume [ Time Frame: 9 months ]
    determination of factors influencing the ejaculation changing mechanism after BPH surgery by preoperative prostate volume measurement by ultrasound

  3. 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 ]
    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

  4. Changing in urinary output before and after surgery [ Time Frame: Baseline and 9 months ]
    determination of factors influencing the ejaculation changing mechanism after BPH surgery by changing in urinary output before and after surgery

  5. Evaluation of urinary symptoms questionary (IPSS) before and after surgery [ Time Frame: Baseline and 9 months ]
    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

  6. 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 ]
    determination of factors influencing the ejaculation changing mechanism after BPH surgery by assessment of degree of resection



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918227


Contacts
Contact: Aurélien DESCAZEAUD, MD +33555058015 aureliendescazeaud@gmail.com

Locations
France
CHU de LIMOGES Recruiting
Limoges, France, 87042
Contact: Aurélien DESCAZEAUD, MD    +33555058015    aureliendescazeaud@gmail.com   
Parc Euromédecine - Centre de Santé de Languedoc Mutualité Euromédecine Not yet recruiting
Montpellier, France, 34090
Contact: Antoine FAIX, MD    +33467029222    a.faix@languedoc-mutualite.fr   
CHU de Nîmes Recruiting
Nîmes, France, 30029
Contact: Stéphane Droupy, MD    +33466683353    stephane.droupy@chu-nimes.fr   
Aphp - Hôpital Cochin Recruiting
Paris, France, 75679
Contact: Nicolas Barry Delongchamps, MD    +33158412756    nicolas.barry-delongchamps@aphp.fr   
CHU de Toulouse Suspended
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Aurélien DESCAZEAUD, MD Limoges Univerity Hospital

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02918227     History of Changes
Other Study ID Numbers: I15028 (EMMECH)
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Limoges:
Ejaculation
Benign Prostatic Hyperplasia
Prostate

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male