Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05617261 |
| Other study ID # |
HS25658 (B2022:092) |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 13, 2022 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
November 2022 |
| Source |
University of Manitoba |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Background:
The current standard of care for the vast majority of urological procedures is the
administration of general anesthesia, spinal anesthesia, or anesthesia-delivered sedation -
requiring the operating room. However, this poses significant challenges associated with
operating room costs, resources, and patient wait times. Given lengthy surgical backlogs,
priority is focused on more acute conditions such as malignancies that require immediate
intervention. Procedures for non-acute conditions, such as penile and scrotal procedures,
have wait times that can exceed six months. Since most treatment for penile and scrotal cases
tends to be surgical intervention, delays in these procedures may significantly negatively
impact patients' sexual health, relationships, mental health, and quality of life. The
ability to perform these procedures outside of the operating room using local anesthesia with
or without conscious sedation may significantly reduce patient wait times and the costs of
surgical intervention. Furthermore, the use of conscious sedation would allow for faster
post-operative recovery, shorter procedural times, and decreased risks/side effects
associated with general anesthesia.
Fields such as plastic surgery have successfully transitioned certain procedures into a
clinic- based setting and the field of urology had also shown a similar interest. The
investigators research team has been at the forefront of this transition - previously
demonstrating the efficacy of distal ureteroscopy under nursing administered conscious
sedation and other common urologic procedures. However, these studies were limited as they
did not examine invasive scrotal and penile procedures, which have an extraordinary impact on
the sexual health of patients.
Significance:
This project will provide evidence on the efficacy and characteristics of successful penile
and scrotal procedures conducted under the administration of local anesthesia with or without
conscious sedation. The findings of this study will help transition additional urological
procedures into a clinic-based setting safely: improving the sexual and mental health of
patients while decreasing cost, wait times, procedure duration, recovery times, and
anesthetic-related complications.
Methods:
The proposed study is a prospective study. Eligible patients at the Manitoba Men's Health
Clinic (Winnipeg, MB, Canada) will be approached for potential enrollment. Procedures with or
without conscious sedation are routinely performed at this clinic with volumes of 15-20
procedures performed weekly.
Patients will be approached individually for potential recruitment into the study. Prior to
their urological procedure, patients will be seen by a member of the research team to
determine if they are willing to participate in the study. These meetings will occur in the
pre-operative waiting room at the Manitoba Men's Health Clinic where a member of the research
team who is involved in the care of that patient, will review the medical chart to ensure the
candidate meets the inclusion and exclusion criteria of the study. After discussing the
study, potential participants will have the opportunity to decide whether they would like to
be involved or not. Those who choose to be involved in the study will have to sign an
informed consent form. Patients may withdraw consent and terminate participation at any time.
Each participant will be assigned a study number to track them over time. Electronic data
forms will be used to collect preliminary information for all patients who consent to the
study. Baseline variables for collection will include patient age, sex, BMI, co-morbidities,
medications, smoking/drinking/illicit substance use, and family history of notable diseases.
Clinical variables collected will include procedure side (where applicable), medication dose
used for sedation, quantity and type of local anesthetic, procedural and recovery times,
patient-reported and surgeon-reported visual analogue scale pre-, intra-, and post-operation.
The statistical tests will include univariable and multivariable analyses. All the variables
defined above in the data collection section will be analyzed to determine if there is an
association between any of these variables and the patient-reported outcomes after the
urological procedure. Normally distributed continuous data will be reported as the mean ± the
standard deviation. Non-normally distributed data will be presented using the median and the
interquartile range. Multivariable adjusted logistic regression analysis will be used to
assess predictors of whether a patient would opt for conscious sedation again as opposed to
general/spinal anesthesia. SPSS Version 24.0 (SPSS Inc, IBM, Chicago, IL) will be used for
data analysis.
Personal Health Information Act (PHIA) compliance of the investigators database will be
ensured by preventing unauthorized access and implementing security measures such as password
protecting the electronic database and never permanently storing the database on a mobile
device or flash drive. Data will only be stored on the desktop computer enclosed in the
Manitoba Men's Health Clinic. Database information will only be emailed using a password-
protected, encrypted file. Information presented at meetings and conferences will be de-
identified and anonymous. The Research Ethics Board has approved this study at the University
of Manitoba.
