Clinical trial NCT01525498: Foley Catheterization Following Sacrocolpopexy
Official title: Urinary Bladder Catheterization Following Sacrocolpopexy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pelvic Organ Prolapse
Catheter Infection
Urinary Retention
Keywords: Pelvic Organ Prolapse
Catheterization
Urinary tract infection
Urinary retention
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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 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

Primary outcomes:
measure: Urinary retention following catheter removal
timeFrame: 2 days
measure: need for repeat catheterization
timeFrame: 2 days
measure: Presence of bacteriuria at catheter removal
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Abbas Shobeiri, MD
role: PRINCIPAL_INVESTIGATOR
References: