Combined Spinal Epidural Urinary Retention

NCT01597791 | Terminated Results

• 1 other identifier: STU00005516
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that many parturients can, in fact, spontaneously micturate with low dose combined spinal epidural analgesic doses given for labor and that Foley catheterization is unnecessary in the majority of these parturients. At Prentice Women's Hospital, almost 9000 women annually receive neuraxial labor analgesia and 98% of those receive Foley catheters. By potentially reducing the necessity for Foley catheters, the investigators should be able to ultimately reduce the rate of bacteriuria, urinary tract infections and urethritis leading to unnecessary treatment with antibiotics, as well as reduce costs of placing unnecessary Foley catheter.The hypothesis is parturients receiving low dose combined spinal epidural analgesia for analgesia after induction of labor who are randomized to a spontaneous micturition protocol will require fewer Foley catheter placements and demonstrate a lower incidence of positive urine culture postpartum than those who undergo standard Foley catheter placement.

Conditions

Anesthesia; Pain; Urinary Retention

Keywords

Urinary Retention; Urinary Catheter; Bacteriuria

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Positive Urine Culture

  This study will be assessed by collecting a twenty-four to forty-eight hour midstream urine sample and performing a urine culture. The clinical and laboratory criteria used to define a urinary tract infection.

  48 Hours

Study Arms (2)

Foley catheter

PLACEBO COMPARATOR

Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution.

Device: Foley catheter

No Foley Catheter

EXPERIMENTAL

Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.

Other: No foley catheter

Interventions

Foley catheter DEVICE

Foley catheter placement after CSE.

Foley catheter

No foley catheter OTHER

Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.

No Foley Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nulliparous
• Term (≥37 week gestation)
• Healthy
• ASA class 1-2
• Who are being induced for labor who request labor analgesia and who successfully receive standard combined spinal epidural analgesia (verbal rating score for pain ≤ 1 after 10 min)

You may not qualify if:

• Women with ASA 3 or greater
• BMI ≥40 kg/m2
• Prior history of urge or stress incontinence or urinary retention before pregnancy
• Women with a history of nephrolithiasis
• Chronic urinary tract infections
• Women whose post-void residual volume as assessed by ultrasonography is found to be \>100ml before epidural placement will be excluded.
• Women with an absolute or relative contraindication to the usual combined spinal epidural technique
• Failed analgesia will be excluded
• Women for whom the anesthesiologist selects an analgesic technique other than combined spinal epidural technique or fail to obtain CSF for CSE will be excluded
• Women with fetal heart rate decelerations before request for analgesia will be excluded due to increased risk of cesarean delivery.
• Women who experience inadequate labor analgesia due to nonfunctioning epidural catheter necessitating epidural replacement will be included but noted as a protocol violation.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pain; Urinary Retention; Bacteriuria

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Tract Infections; Infections

Limitations and Caveats

The study was terminated early because of difficulty using the ultrasound device to estimate urinary bladder capacity and residual levels.

Results Point of Contact

• Title: Paul Fitzgerald
• Organization: Northwestern University

p-fitzgerald2@northwestern.eud

312-695-1064

Study Officials

• Jeanette Bauchat, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 14, 2012
• Study Start: March 22, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 5, 2018
• Results First Posted: October 10, 2017

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)