Clinical trial NCT00392210: Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery
Official title: Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2006-10-25
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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 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).

Primary outcomes:
measure: Number of Participants Who Passed Bladder Trial
timeFrame: postoperatively after surgery on day1 or 2
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Michael K. Flynn, MD
role: PRINCIPAL_INVESTIGATOR
References: