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Foley Catheterization

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01525498
First received: January 19, 2012
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

The objective of this study is to prospectively evaluate the effects of early versus delayed removal of transuretheral catheters following sacrocolpopexy. The investigators specific aim is to determine the optimal time of removal of an indwelling transurethral catheter postoperatively in an effort to reduce the risk of postoperative urinary retention and urinary tract infection associated with catheter use. The investigators hypotheses are as follows:

Hypothesis 1: Longer duration of postoperative catheter use will result in decreased postoperative urinary retention.

Hypothesis 2: Shorter duration of postoperative catheter use will result in lower incidence of urinary tract infection.


Condition
Pelvic Organ Prolapse
Catheter Infection
Urinary Retention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Urinary Bladder Catheterization Following Sacrocolpopexy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Urinary retention following catheter removal [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • need for repeat catheterization [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Presence of bacteriuria at catheter removal [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 584
Study Start Date: August 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1 day catheter removal
Participants randomized to group 1 will have their catheter removed 1 day after surgery.
2 day catheter removal
Participants randomized to group 2 will have their catheter removed 2 days after surgery.

Detailed Description:

Patients scheduled to undergo sacrocolpopexy for pelvic organ prolapse at the University of Oklahoma Health Sciences Center will be recruited for this study. Written informed consent will be obtained from all participants prior to the scheduled surgery and before the randomization process. This study will contain two arms, each with two groups. The first arm will have participants receiving sacrocolpopexy for pelvic organ prolapse; the second arm will consist of participants receiving sacrocolpopexy plus a concomitant procedure for stress urinary incontinence. Each participant will be assigned to the arm that matches their scheduled procedure; they will then be randomized into one of the two study groups within that arm. Randomization will be performed by placing note cards in sealed envelopes with "Group A" or "Group B" listed on the card. One envelope will be placed with each participant's preoperative packet and opened on the day of surgery after the operation is complete.On the date of the procedure, a urinalysis will be performed prior to the routine administration of prophylactic antibiotics. At the beginning of the procedure, a transurethral catheter will be placed as is routine for this procedure. At the conclusion of the procedure, the sealed envelope containing the participant's group designation will be opened and she will be assigned to one of two groups. Group A participants will have their catheter removed on postoperative day 1 and Group B will have their catheter removed on postoperative day 2.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The projected sample size is 584 participants. Participants will be drawn from the University of Oklahoma Urogynecology clinics. Our catchment area includes OU Physicians clinic (private clinic) and Presbyterian Professional Building (resident clinic).

Criteria

Inclusion Criteria:

  • Age at least 21
  • Scheduled to undergo sacrocolpopexy at the University of Oklahoma Health Sciences Center

Exclusion Criteria:

  • Age < 21
  • Elevated postvoid residual measurement on preoperative exam
  • History of urinary retention
  • Medical or surgical indication for prolonged catheterization
  • History of neurologic problems
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525498

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Abbas Shobeiri, MD University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01525498     History of Changes
Other Study ID Numbers: Foley
Study First Received: January 19, 2012
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Pelvic Organ Prolapse
Catheterization
Urinary tract infection
Urinary retention

Additional relevant MeSH terms:
Prolapse
Urinary Retention
Pelvic Organ Prolapse
 Pathological Conditions, Anatomical
Urination Disorders
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013