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Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery

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ClinicalTrials.gov Identifier: NCT00392210
Recruitment Status : Completed
First Posted : October 25, 2006
Results First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
University of Rochester

Brief Summary:
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 or disease Intervention/treatment Phase
Urinary Incontinence Genetic: Voiding Trial Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery
Study Start Date : October 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Spontaneous Fill
Active Comparator: Retrograde Fill Genetic: Voiding Trial
Post-void residual and uroflow study will be done twice




Primary Outcome Measures :
  1. Number of Participants Who Passed Bladder Trial [ Time Frame: postoperatively after surgery on day1 or 2 ]
    Voiding trial 1 was performed according to the patient assignment to group 1 or 2. Voiding trial 2 was done immediately after completion of trial 1. A successful trial was defined as a void of greater than two-thirds of total bladder volume (voided volume + post-void residual urine).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392210


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Michael K. Flynn, MD University of Rochester
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Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00392210    
Other Study ID Numbers: 15107
First Posted: October 25, 2006    Key Record Dates
Results First Posted: April 27, 2017
Last Update Posted: April 27, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms