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

NCT05617261 | Unknown

• 1 other identifier: HS25658 (B2022:092)
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Conscious sedation; Local anesthesia; Penile; Scrotal; Patient reported outcomes

Outcome Measures

Primary Outcomes (1)

• Patient reported tolerability

  Patient tolerability as assessed using a standardized questionnaire administered to patients. Key questions of interest are if patients would opt for conscious sedation for a repeat procedure or general anesthesia, recommend conscious sedation to a friend undergoing a similar procedure, and a scale question with self-reported tolerability ranging from 0-10 with a higher value corresponding to an excellent experience.

  Standardized questionnaire will be administered to patients 4-6 weeks after their individual procedure.

Interventions

Conscious sedation OTHER

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).

Eligibility Criteria

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

Study Population

Patients undergoing: hydrocelectomy, spermatocelectomy, varicocelectomy, epididymectomy, testicular biopsy, adult circumcision, frenulectomy, penile plication, orchiectomy, and vasectomy reversal at the Manitoba Men's Health Clinic (Winnipeg, MB, Canada) will be approached for potential enrolment.

You may qualify if:

• patients over the age of 18
• undergoing one of the previously mentioned procedures under local anesthesia with or without conscious sedation
• having a minimum follow-up of 4-6 weeks.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Men's Health Clinic Manitoba

Winnipeg, Manitoba, Canada

Location

Related Publications (1)

• Bal DS, Chung D, Urichuk M, Shah J, Fidel MG, Panchendrabose K, Sidhom K, Bard R, Nayak JG, Patel P. Utilizing Local Anesthesia Only for Penile and Scrotal Urologic Surgery: A Prospective Study on Patient Tolerability and Surgical Outcomes for a Sedation-free Option. Urology. 2024 Dec;194:7-13. doi: 10.1016/j.urology.2024.08.051. Epub 2024 Aug 28.

  PMID: 39208947 DERIVED

MeSH Terms

Conditions

Testicular Hydrocele; Spermatocele; Varicocele; Testicular Diseases; Penile Diseases

Interventions

Conscious Sedation

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases; Cysts; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Premal Patel, MD

  Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 15, 2022
• Study Start: November 13, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

CA (1)