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OpenTrials
Completed

NCT Number: NCT00392210

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Voiding Trial

Genetic

Post-void residual and uroflow study will be done twice

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 25, 2006
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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