Urinary Incontinence
Conditions
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.
Interventions
GENETICVoiding Trial
Post-void residual and uroflow study will be done twice
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Passed Bladder Trial | 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). |
Countries
United States
Participant flow
Recruitment details
271 potential subjects were identified. 192 declined participation so 79 were enrolled.
Pre-assignment details
10 subjects were withdrawn prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| Auto Fill Followed by Back Fill The Auto fill-method was performed immediately followed by the back-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first. | 41 |
| Back Fill Followed by Auto Fill The back fill-method was performed immediately followed by the auto-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first. | 38 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Voiding Trial | Physician Decision | 2 | 2 |
Baseline characteristics
| Characteristic | Back Fill Followed by Auto Fill | Auto Fill Followed by Back Fill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 16 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 25 Participants | 46 Participants |
| Age, Continuous | 57.58 years STANDARD_DEVIATION 10.04 | 60.73 years STANDARD_DEVIATION 12.05 | 59.02 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 38 participants | 41 participants | 79 participants |
| Sex: Female, Male Female | 38 Participants | 41 Participants | 79 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 69 | 0 / 69 |
| serious Total, serious adverse events | 0 / 69 | 0 / 69 |
Outcome results
Primary
Number of Participants Who Passed Bladder Trial
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).
Time frame: postoperatively after surgery on day1 or 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Auto Fill Intervention | Number of Participants Who Passed Bladder Trial | 25 participants |
| Back Fill Intervention | Number of Participants Who Passed Bladder Trial | 39 participants |