Foley Catheterization Following Sacrocolpopexy

Pelvic Organ Prolapse Clinical Trial

Official title:

Urinary Bladder Catheterization Following Sacrocolpopexy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01525498
• Other study ID #: Foley
• Status: Withdrawn
• Phase: N/A
• First received: January 19, 2012
• Last updated: October 15, 2013
• Start date: August 2011
• Est. completion date: April 2013

Study information

• Verified date: October 2013
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Catheter Infection
• Pelvic Organ Prolapse
• Prolapse
• Urinary Retention

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary retention following catheter removal		2 days	No
Primary	need for repeat catheterization		2 days	No
Primary	Presence of bacteriuria at catheter removal		2 days	No