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NCT05617261

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

Status unknown Last updated 15 November 2022
What this trial tests

trial testing Conscious sedation in Hydrocele in 150 participants. Status unknown.

Timeline
13 November 2022
Primary endpoint
1 June 2023
1 June 2023

Quick facts

Lead sponsorUniversity of Manitoba
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment150
Start date13 November 2022
Primary completion1 June 2023
Estimated completion1 June 2023
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of Manitoba

Who can join

18 and older, male only, with Hydrocele or Spermatocele. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Utilizing Local Anesthesia Only for Penile and Scrotal Urologic Surgery: A Prospective Study on Patient Tolerability and Surgical Outcomes for a Sedation-free Option.
    Bal DS, Chung D, Urichuk M, Shah J, et al · · 2024 · cited 5× · PMID 39208947 · DOI 10.1016/j.urology.2024.08.051
  2. Poster Session 11: Sexual Health, Infertility : Monday, July 1, 2024 • 7:00–8:30
    Sljivich M, Kahan D, Allan C, Djordjevic M, et al · · 2024
  3. CUA 2023 Annual Meeting Abstracts – Poster Session 4: Transplant, Other : Saturday, June 24, 2023 • 16:10–17:40
    Taka M, Sener A, Koven A, Hysi E, et al · · 2023

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Other trials of Conscious sedation

Trials testing the same drug.

Other University of Manitoba trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05617261.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing