Health TrialsbyHealthPanel

Ejaculatory Behavior and Seminal Vesicle Size During Radical Prostatectomy

ConditionProstate Cancer Patients Undergoing Radical Prostatectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorNational Taiwan University Hospital

About this trial

The goal of this clinical trial is to learn if recent ejaculation or abstinence before surgery affects seminal vesicle size and dissection-related surgical factors in adult men with prostate cancer undergoing radical prostatectomy. The main questions it aims to answer are:

Does ejaculation within 36 hours before surgery reduce seminal vesicle size compared to abstinence of 72 hours or more?

Does seminal vesicle size affect the ease or difficulty of surgical dissection during radical prostatectomy?

Researchers will compare an ejaculation group to an abstinence group to see if seminal vesicle volume and intraoperative surgical parameters differ between them.

Participants will:

Follow specific instructions to either ejaculate or abstain before surgery

Undergo a transrectal ultrasound (TRUS) to measure seminal vesicle size after anesthesia but before surgery

Have their surgical dissection time and difficulty rated by the operating surgeon

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male patients aged 18 years or older

Histologically confirmed prostate cancer

Scheduled for radical prostatectomy

Able and willing to comply with assigned ejaculation or abstinence protocol

Disqualifiers

Prior bilateral seminal vesicle resection or congenital absence of seminal vesicles

Anatomical abnormalities preventing SV identification

Hormone therapy within 6 months before surgery

Inability to recall ejaculation history in the past 3 days

Trial design

Design model

Parallel

Treatments tested in this trial

  • Recent Ejaculation

    Behavioral

    Participants are instructed to ejaculate at least once within 36 hours prior to radical prostatectomy. This behavioral intervention is used to evaluate its effect on seminal vesicle volume and intraoperative dissection parameters.

  • Preoperative Abstinence

    Behavioral

    Participants are instructed to abstain from ejaculation for at least 72 hours prior to radical prostatectomy. This behavioral intervention is used to assess whether prolonged seminal vesicle filling affects intraoperative anatomy and dissection.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Recent Ejaculation GroupExperimental treatment 1 intervention
Group B: Abstinence GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Seminal vesicle volume measured by preoperative transrectal ultrasound (TRUS)

Seminal vesicle volume is measured by the research investigator using transrectal ultrasound (TRUS) in the outpatient ultrasound room approximately 12-14 hours before surgery. Both vesicles are measured in three dimensions (length × width × height), and the average volume is calculated using the ellipsoid formula (L × W × H × 0.52). The values will be compared between groups with recent ejaculation versus abstinence.

Time frame
12-14 hours before surgery (afternoon prior to operation)

Secondary outcomes

1

Dissection time of seminal vesicles during radical prostatectomy

The time required for bilateral seminal vesicle dissection is recorded in minutes from surgical video or intraoperative notes.

Time frame
During surgery (intraoperative)
2

Surgical difficulty score of seminal vesicle dissection

The primary surgeon rates the difficulty of SV dissection on a Likert scale from 1 (very easy) to 5 (very difficult), based on anatomical clarity and tissue handling.

Time frame
Immediately after SV dissection during surgery
3

Intraoperative visual clarity score of seminal vesicles

The operating surgeon rates visual clarity of the surgical field (especially SV region) using a Likert scale from 1 (very poor) to 5 (excellent).

Time frame
During SV dissection, intraoperatively
4

Seminal vesicle volume reported in postoperative pathology

Pathology reports include three-dimensional measurements of both SVs. Final volume is calculated using the same ellipsoid formula and compared with TRUS findings.

Time frame
Within 7 days after surgery (postoperative pathology report)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: