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Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery
This study is currently recruiting participants.
Verified by University of Rochester, October 2006
Sponsored by: University of Rochester
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00392210
  Purpose

After gynecologic surgery, it may be difficult to void (urinate). This problem is usually short-term with normal function returning within a few days to a few weeks. For this reason, patients may require drainage of their bladder with a catheter immediately after surgery. Currently in our office, we use two different tests to see how well you are able to urinate and how quickly the catheter can be removed. The purpose of this study is to see which voiding test is better after gynecologic surgery.


Condition Intervention
Urinary Incontinence
Procedure: Voiding Trial

MedlinePlus related topics: Urinary Incontinence Urine and Urination
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Historical Control, Crossover Assignment, Efficacy Study
Official Title: Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • The primary hypothesis is that the two tests will have equivalent “fail” rates. If this is not true, the test with the higher “fail” rate would be determined to have a higher false positive rate.

Secondary Outcome Measures:
  • Safety (false negative rate, expected to be near zero) will be assessed as a secondary outcome.

Estimated Enrollment: 400
Study Start Date: October 2006
Detailed Description:

Postoperative voiding dysfunction is commonly encountered following gynecologic surgery. This dysfunction is usually short term, with normal function returning within a few days. Following uro/gynecologic surgery, most patients require drainage with either a transurethral or suprapubic catheter in the immediate postoperative period. Within our practice, we prefer drainage with a transurethral catheter.

At some point after surgery, the urethral catheter is removed and normal bladder function allowed to resume. At present, there is no generally accepted regimen to assess voiding efficiency. In our practice, we currently employ two regimens to both assess voiding efficiency and expedite catheter removal. In one technique, the catheter is removed and the patient’s bladder is allowed to fill spontaneously. Patients are asked to void when they experience a strong urge. The voided volume is recorded and a post-void residual (PVR) is then measured by transurethral straight catheterization.

In the second technique, the patient’s bladder is retrogradely filled with 300 cc of sterile fluid and the catheter removed. They are asked to void within 15 minutes of instillation and the voided volume is measured. The PVR is then obtained by transurethral straight catheterization.

In both cases, if the patient voids >2/3 the total volume (voided volume + residual) the trial is considered “passed” and the catheter is removed. If a patient voids < 2/3 of the total volume, the trial is considered “failed” and indicative of urinary retention. In this case the catheter replaced.

We aim to assess the ability of these techniques to accurately predict voiding efficiency and to determine if one technique is superior to the other.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All women > 18 years of age presenting to the Division of Urogynecology at the University of Rochester Medical Center/Strong Memorial Hospital and undergoing gynecologic surgery which requires postoperative placement of a transurethral catheter.
  • Subjects must be competent to give informed consent.

Exclusion Criteria:

  • Any patient less than 18 years of age.
  • Patients with suprapubic catheters postoperatively.
  • Patients undergoing surgery that does not require transurethral catheterization postoperatively.
  • Patients not competent to give informed consent.
  • Patients who are pregnant.
  • Patients undergoing procedures requiring prolonged bladder decompression (i.e. fistula repair).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392210

Contacts
Contact: Mare Perevich, RN 585-273-2996 mare_perevich@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: James Q. Pulvino, MD     585-273-3312     james_pulvino@urmc.rochester.edu    
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: James Q. Pulvino, MD University of Rochester
  More Information

Study ID Numbers: 15107
Study First Received: October 23, 2006
Last Updated: April 23, 2007
ClinicalTrials.gov Identifier: NCT00392210  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Signs and Symptoms
Urologic Diseases
Urination Disorders
Urinary Incontinence

Additional relevant MeSH terms:
Urological Manifestations

ClinicalTrials.gov processed this record on January 14, 2009