NCT02547155

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

2.8 years

First QC Date

July 15, 2015

Last Update Submit

April 19, 2017

Conditions

Urinary RetentionUterine Prolapse

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative urinary retention

    bladder emptying completeness after surgery

    within the first week after surgery

Study Arms (2)

Spinal anesthesia

EXPERIMENTAL

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.

Procedure: Spinal anesthesia

General anesthesia

ACTIVE COMPARATOR

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

Procedure: General anesthesia

Interventions

Spinal anesthesiaPROCEDURE

8-12.5 mg of bupivacaine will be administered for spinal anesthesia

Spinal anesthesia
General anesthesiaPROCEDURE

propofol induction, in combination with a muscle relaxant and inhalational gas

General anesthesia

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30904934DERIVED

MeSH Terms

Conditions

Urinary RetentionUterine Prolapse

Interventions

Anesthesia, SpinalAnesthesia, General

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Laura Martin, DO

    Clevland Clinic Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Maritn, DO

CONTACT

954-659-5559martinl4@ccf.org

G Willy Davila, MD

CONTACT

954-659-5559davilag@ccf.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urogynecology Fellow in the Department of Gynecology

Study Record Dates

First Submitted

July 15, 2015

First Posted

September 11, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 20, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)