Foley Catheterization Following Sacrocolpopexy

NCT01525498 | Withdrawn

• 1 other identifier: Foley
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse; Catheter Infection; Urinary Retention

Keywords

Pelvic Organ Prolapse; Catheterization; Urinary tract infection; Urinary retention

Outcome Measures

Primary Outcomes (3)

• Urinary retention following catheter removal

  2 days

• need for repeat catheterization

  2 days

• Presence of bacteriuria at catheter removal

  2 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• Age \< 21
• Elevated postvoid residual measurement on preoperative exam
• History of urinary retention
• Medical or surgical indication for prolonged catheterization
• History of neurologic problems

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Retention; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Study Officials

• Abbas Shobeiri, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: February 3, 2012
• Study Start: August 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

US (1)