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Does Spinal Anesthesia for Prolapse Surgery With Lead to Urinary Retention?
N/A
Waitlist Available
Led By Laura Martin, DO
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the first week after surgery
Awards & highlights
No Placebo-Only Group
Summary
The purpose of the study is to compare the risk of being unable to urinate shortly after surgery, also called acute post-operative urinary retention (POUR) between spinal and general anesthesia in women who undergo outpatient pelvic organ prolapse with stress urinary incontinence surgery.
Eligible Conditions
- Urinary Retention
- Uterine Prolapse
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within the first week after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the first week after surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of postoperative urinary retention
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Spinal anesthesiaExperimental Treatment1 Intervention
Subjects randomized to spinal anesthesia will receive Bupivacaine 0.75%, 8-12.5 mg dose depending on estimated duration of surgery and anesthesiologist decision. In addition to spinal anesthesia, these subjects will possibly have concurrent administration of fentanyl, midazolam, and propofol so that they are mildy sedated or sleeping.
Group II: General anesthesiaActive Control1 Intervention
Subjects randomized to general anesthesia will receive propofol induction, in combination with a muscle relaxant and inhalational gas per anesthesia standard of care at our institution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal anesthesia
2017
Completed Phase 4
~3960
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,404 Total Patients Enrolled
4 Trials studying Urinary Retention
913 Patients Enrolled for Urinary Retention
Laura Martin, DOPrincipal InvestigatorClevland Clinic Florida
2 Previous Clinical Trials
71 Total Patients Enrolled