Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

— EMMECH  

Official title:

Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02918227
• Other study ID #: I15028 (EMMECH)
• Status: Terminated
• Phase: N/A
• Start date: December 8, 2016
• Est. completion date: June 11, 2018

Study information

• Verified date: June 2019
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 11, 2018
• Est. primary completion date: June 11, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Ejaculation
• Hyperplasia
• Prostate
• Prostatic Hyperplasia

Intervention

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.

Locations

Country	Name	City	State
France	CHU de LIMOGES	Limoges
France	CHU de Nîmes	Nîmes
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	retrograde ejaculation (R)	retrograde ejaculation is determined by the difference in percentage of retrograde ejaculation between postoperative and preoperative	Baseline and 9 months
Primary	Evaluation of the coefficient C	A and R will be subtracted to obtain the coefficient C	9 months
Secondary	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
Secondary	Preoperative prostate volume	determination of factors influencing the ejaculation changing mechanism after BPH surgery by preoperative prostate volume measurement by ultrasound	9 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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