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Does Spinal Anesthesia for Prolapse Surgery With Lead to Urinary Retention?

Primary Purpose

Urinary Retention, Uterine Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal anesthesia
General anesthesia
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Retention

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Women over the age of 40
  2. Women scheduled for pelvic organ prolapse surgery as well as concomitant incontinence sling surgery
  3. Post-void residual <150 cc prior to surgery
  4. Surgery length of at least 1 hour
  5. BMI <40
  6. ASA class 1-2

Exclusion Criteria:

  1. Contraindications to surgery
  2. Contraindications to outpatient surgery, and requiring inpatient stay for medical comorbidities. The decision for a required inpatient stay will be decided prior to surgery based on the recommendations of the patient's primary care physician or specialist, such as cardiology or pulmonology.
  3. BMI >40
  4. ASA class 3 or 4 that would be a contraindiction to both spinal or general anesthesia
  5. Evidence of voiding dysfunction or urinary retention on pre-operative urodynamics, including PVR >150, or dyssynergic sphincter dyssynergia
  6. Neurological diseases that can interfere with spinal anesthesia
  7. Anticoagulation therapy within a week of surgery
  8. History of back surgery that would prevent successful spinal anesthesia
  9. History of back deformity, such as scoliosis that would prevent successful spinal anesthesia

Sites / Locations

  • Cleveland Clinic FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spinal anesthesia

General anesthesia

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Incidence of postoperative urinary retention
bladder emptying completeness after surgery

Secondary Outcome Measures

Full Information

First Posted
July 15, 2015
Last Updated
April 19, 2017
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02547155
Brief Title
Does Spinal Anesthesia for Prolapse Surgery With Lead to Urinary Retention?
Official Title
Does Spinal Anesthesia for Prolapse Surgery With Concomitant Sling Procedures Lead to an Increase in Urinary Retention Compared to General Anesthesia?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
A randomized trial to compare urinary retention rates between spinal and general anesthesia in women who undergo outpatient pelvic organ prolapse surgery with concomitant incontinence surgery. Randomization Randomization will be done in the pre-operative area, on the day of surgery. Computer generated randomization will be done in blocks of 4. Sealed numbered envelopes will be opened prior to surgery and the subject will then be assigned to spinal or general anesthesia. Patient randomization on day of surgery was discussed with anesthesia and it thought that randomizing on the same day would be safe. Preoperatively Subjects will be asked to complete a validated questionnaire, the Quality of Recovery 15 (QoR-15) prior to surgery, at their preoperative visit. Anesthesia Subjects randomized to general anesthesia will receive propofol induction, in combination with a muscle relaxant and inhalational gas per anesthesia standard of care at the investigators' institution. Subjects randomized to spinal anesthesia will receive Bupivacaine 0.75%, 8-12 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. Voiding Trial A voiding trial will be performed in the PACU once the subjects are able to stand and ambulate to the bathroom. Voiding trial will consist of removing the vaginal packing and back filling the bladder with 300cc of saline or less if subject has urgency or a smaller bladder capacity. A voiding trial is considered successful if the subject voids at least 2/3 of the total volume instilled and has a bladder scan showing less than 1/3 remaining. If a subject is unable to void after an hour, an additional hour will be permitted. However, after 2 hours from when the bladder was backfilled the subject is still unable to void, the Foley will be replaced and the subjects will be discharged home with a Foley leg bag and leg bag teaching. An office nurse will call the subject and schedule an office nurse visit to remove the Foley between post-operative day number 5 to 7. If the subject goes home with a Foley this will be considered acute POUR. Follow Up Subjects will receive a phone call from either a nurse or fellow, between 48 to 72 hours post-operatively to make sure they are having no symptoms of urinary retention, are doing well and are not having any complications. A telephone survey will be administered during this follow up phone call using a validated questionnaire, the QoR-15. They will have received a copy of this survey to refer to at the time of their hospital discharge. Subjects who were admitted to the hospital will have the same follow up, including a phone call 48 to 72 hours after their surgery, including the validated questionnaire, the QoR-15. In addition, subjects will have a 6 week follow up visit in the clinic and will be asked to complete the QoR-15.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Uterine Prolapse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal anesthesia
Arm Type
Experimental
Arm Description
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.
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia
Intervention Description
8-12.5 mg of bupivacaine will be administered for spinal anesthesia
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
propofol induction, in combination with a muscle relaxant and inhalational gas
Primary Outcome Measure Information:
Title
Incidence of postoperative urinary retention
Description
bladder emptying completeness after surgery
Time Frame
within the first week after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women over the age of 40 Women scheduled for pelvic organ prolapse surgery as well as concomitant incontinence sling surgery Post-void residual <150 cc prior to surgery Surgery length of at least 1 hour BMI <40 ASA class 1-2 Exclusion Criteria: Contraindications to surgery Contraindications to outpatient surgery, and requiring inpatient stay for medical comorbidities. The decision for a required inpatient stay will be decided prior to surgery based on the recommendations of the patient's primary care physician or specialist, such as cardiology or pulmonology. BMI >40 ASA class 3 or 4 that would be a contraindiction to both spinal or general anesthesia Evidence of voiding dysfunction or urinary retention on pre-operative urodynamics, including PVR >150, or dyssynergic sphincter dyssynergia Neurological diseases that can interfere with spinal anesthesia Anticoagulation therapy within a week of surgery History of back surgery that would prevent successful spinal anesthesia History of back deformity, such as scoliosis that would prevent successful spinal anesthesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Maritn, DO
Phone
954-659-5559
Email
martinl4@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
G Willy Davila, MD
Phone
954-659-5559
Email
davilag@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Martin, DO
Organizational Affiliation
Clevland Clinic Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Martin, MD
Phone
954-659-5559
Email
martinl4@ccf.org
First Name & Middle Initial & Last Name & Degree
Laura Martin, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30904934
Citation
Alas A, Martin L, Devakumar H, Frank L, Vaish S, Chandrasekaran N, Davila GW, Hurtado E. Anesthetics' role in postoperative urinary retention after pelvic organ prolapse surgery with concomitant midurethral slings: a randomized clinical trial. Int Urogynecol J. 2020 Jan;31(1):205-213. doi: 10.1007/s00192-019-03917-w. Epub 2019 Mar 23.
Results Reference
derived

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Does Spinal Anesthesia for Prolapse Surgery With Lead to Urinary Retention?

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