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Evaluating Patient Tolerability and Success for Penile and Scrotal Urologic Procedures Under Conscious Sedation: A Prospective Study

NCT05617261 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2022-11-15

No results posted yet for this study

Summary

The goal of this observational study is to evaluate patient reported outcomes and tolerability of scrotal and penile urologic procedures under the administration of minimal conscious sedation. This will be assessed at 4-6 weeks post-procedure where patients will be followed up with a questionnaire assessing how well patients tolerated the procedure and if patients would opt for conscious sedation again in a similar, future procedure. The investigators will secondarily be assessing the associated cost savings as compared to having these procedures performed under general anesthesia at a tertiary care hospital.

Conditions

  • Hydrocele
  • Spermatocele
  • Varicocele
  • Epididymal Cyst
  • Testicular Biopsy
  • Circumcision
  • Frenulectomy
  • Penile Plication
  • Orchiectomy
  • Vasectomy Reversal
  • Testicular Diseases
  • Penile Diseases

Interventions

OTHER

Conscious sedation

Conscious sedation is a combination of medications to help you relax (a sedative, for example nitrous gas) and to block out pain (commonly known as freezing, for example lidocaine).

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Premal Patel, MD · Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-13
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05617261 on ClinicalTrials.gov