Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia

NCT02918227 | Terminated

• 1 other identifier: I15028 (EMMECH)
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate; Ejaculation; Benign Prostatic Hyperplasia

Keywords

Ejaculation; Benign Prostatic Hyperplasia; Prostate

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Type of surgery

  9 months

• Preoperative prostate volume

  9 months

• Evaluation of the coefficient C depending on 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

  Baseline and 9 months

• Evaluation of urinary symptoms questionary (IPSS) before and after surgery

  Baseline and 9 months

Study Arms (1)

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.

Procedure: Search retrograde ejaculation

Interventions

Search retrograde ejaculation PROCEDURE

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.

Search retrograde ejaculation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (3)

CHU de LIMOGES

Limoges, 87042, France

Location

CHU de Nîmes

Nîmes, 30029, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Aurélien DESCAZEAUD, MD

  Limoges Univerity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: September 28, 2016
• Study Start: December 8, 2016
• Primary Completion: June 11, 2018
• Study Completion: June 11, 2018
• Last Updated: June 6, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)