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NCT Number: NCT07243795

Ejaculatory Behavior and Seminal Vesicle Size During Radical Prostatectomy

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

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Cancer Center

Taipei, Outside U.S./Canada, 106, Taiwan

Location contact

Yen Ho, M.D.

CONTACT

[email protected]

886933092258

About this study

Radical prostatectomy (RP) remains a cornerstone treatment for localized prostate cancer. During RP, the anatomical dissection of seminal vesicles (SVs) can be challenging, and SV volume may influence intraoperative visibility, dissection ease, and the risk of complications.

Recent imaging studies suggest that ejaculatory activity significantly affects SV size. In particular, abstinence has been associated with larger SV volumes on MRI and TRUS, while ejaculation may lead to temporary SV shrinkage. These physiological changes, though well-documented radiologically, have not been systematically studied in a surgical setting.

This trial aims to explore whether ejaculatory behavior in the days before RP alters the surgical anatomy and impacts dissection-related metrics. Forty adult male patients with biopsy-confirmed prostate cancer, scheduled for RP, will be randomized in a 1:1 ratio into two groups:

Ejaculation group: At least one ejaculation within 36 hours preoperatively.

Abstinence group: No ejaculation for ≥72 hours before surgery.

Under anesthesia and prior to surgery, transrectal ultrasound (TRUS) will be performed to measure bilateral SV dimensions. The average volume will serve as the primary endpoint. Intraoperative outcomes include dissection time, visual clarity, and perceived difficulty rated by the primary surgeon using a Likert scale. SV volume from final pathology reports will also be collected and compared.

This is a low-risk, behavior-based interventional study involving no experimental drug or device. The main purpose is to assess whether preoperative sexual behavior can be optimized to improve surgical planning and efficiency. Alpha-blocker usage and other potential confounders will be documented and adjusted for in the analysis.

If significant anatomical or procedural differences are observed, findings from this study may inform future multicenter research and guide preoperative patient counseling for RP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Willing to complete preoperative questionnaire
  • Willing to undergo transrectal ultrasound (TRUS) 12-14 hours before surgery
  • Able to understand and sign informed consent

Exclusion criteria

  • 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
  • Inability to follow behavioral instructions or TRUS protocol
  • Severe anorectal disease or history of anorectal surgery preventing TRUS
  • Cognitive or psychiatric conditions impairing informed consent
  • Incomplete data or poor-quality imaging
  • Prior prostate cancer treatment
  • Belonging to a vulnerable population (e.g., minors, prisoners, pregnant individuals, cognitively impaired, etc.)

Treatment and study plan

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.

Other names: Ejaculation within 36 hours before surgery

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.

Other names: Ejaculatory Abstinence ≥72 hours

Primary outcomes

  1. Seminal vesicle volume measured by preoperative transrectal ultrasound (TRUS)

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

    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.

Secondary outcomes

  1. Dissection time of seminal vesicles during radical prostatectomy

    Time frame: During surgery (intraoperative)

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

  2. Surgical difficulty score of seminal vesicle dissection

    Time frame: Immediately after SV dissection during surgery

    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.

  3. Intraoperative visual clarity score of seminal vesicles

    Time frame: During SV dissection, intraoperatively

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

  4. Seminal vesicle volume reported in postoperative pathology

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yen Ho, M.D.

CONTACT

[email protected]

+886933092258

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Impact of Preoperative Ejaculation or Abstinence on Seminal Vesicle Size and Intraoperative Dissection Parameters During Radical Prostatectomy: A Randomized Controlled Trial

Acronym: PreRP-EJAC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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