Foley Catheterization Following Sacrocolpopexy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01525498
Recruitment Status : Withdrawn (No subject accrual)
First Posted : February 3, 2012
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:

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 or disease
Pelvic Organ Prolapse Catheter Infection Urinary Retention

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.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Urinary Bladder Catheterization Following Sacrocolpopexy
Study Start Date : August 2011
Primary Completion Date : April 2013
Study Completion Date : April 2013

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.

Primary Outcome Measures :
  1. Urinary retention following catheter removal [ Time Frame: 2 days ]
  2. need for repeat catheterization [ Time Frame: 2 days ]
  3. Presence of bacteriuria at catheter removal [ Time Frame: 2 days ]

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01525498

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

Responsible Party: University of Oklahoma Identifier: NCT01525498     History of Changes
Other Study ID Numbers: Foley
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

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

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