Foley Catheterization Following Sacrocolpopexy

Urinary Bladder Catheterization Following Sacrocolpopexy

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.

Study Overview

• Status: Withdrawn
• Conditions: Pelvic Organ Prolapse; Urinary Retention; Catheter Infection

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

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary retention following catheter removal	2 days
need for repeat catheterization	2 days
Presence of bacteriuria at catheter removal	2 days

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Abbas Shobeiri, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 19, 2012
• First Submitted That Met QC Criteria: January 31, 2012
• First Posted (Estimate): February 3, 2012

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 15, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Urinary retention; Pelvic Organ Prolapse; Urinary tract infection; Catheterization
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse; Urinary Retention
• Other Study ID Numbers: Foley