Urinary Retention
Conditions
Keywords
Midurethral sling, Pyridium
Brief summary
There has been preliminary data showing that pyridium can decrease the risk of difficulty urinating after midurethral sling. This study is designed to have two groups of patients. One group will receive pyridium pre-operatively, while the other group will have routine preoperative care. Both groups will have their bladder tested prior to going home. It will be evaluated if there is a difference in the difficulty to urinate post-operatively in both groups.
Detailed description
This is a prospective randomized controlled trial. It will have two arms with 48 patients in each arm, a total of 98 patients. Patients will be randomized with a block randomization schedule generated by computerized random numbers using a 1:1 allocation to pyridium and routine perioperative care. The study is powered to see a difference in incidence of urinary retention after midurethral sling using 25% as the historic control for our institution. Statistical sample size was based on a decrease in incidence to 5% in the pyridium arm. This is with 80% power and alpha 0.05. After the patient's surgery, including a midurethral sling, the patient will have an active voiding trial performed as described by Pulvino et al. The patient's bladder will be backfilled with 300cc of sterile saline. If the patient cannot tolerate 300cc, the patient will be filled to maximum capacity. The patient will be allowed 20 minutes to void. The patient must void greater than two thirds the volume that was instilled in the bladder to consider it a passed voiding trial. The timing of the voiding trial will be at the discretion of the surgeon, accounting for factors such as complexity of concomitant surgery, the patient being alert, ambulating, with tolerable pain.
Interventions
DRUGPhenazopyridine
to be given preoperatively
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any female patient undergoing a midurethral sling surgery, regardless of concomitant pelvic reconstructive or gynecological surgery
Exclusion criteria
* Patients with complications from surgery requiring indwelling catheter, bladder/urethral perforation requiring indwelling catheter * Acute bleeding requiring indwelling catheter for accurate urine output calculation * Patients undergoing concomitant surgery other than gynecological, preoperative voiding dysfunction defined as postvoid residual \>150cc, or spinal anesthesia * Women who are pregnant, including women of childbearing age who test positive on preoperative urine pregnancy test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Considered to Have Passed Their Voiding Trial | Day 1 | Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial. |
| Incidence of Urinary Retention | Day 1 | Incidence of participants that do not pass their voiding trial and go home with an indwelling foley |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scale | Day 1: 6-8 hours after surgery | Pain scale from 0-10. 0-being no pain, 10-being the most pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pyridium Arm Phenazopyridine 200mg tablet, once prior to surgery
Phenazopyridine: to be given preoperatively | 46 |
| Control Arm No intervention in this group. Routine perioperative care. | 45 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 3 | 4 |
Baseline characteristics
| Characteristic | Pyridium Arm | Total | Control Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 28 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 63 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 28 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 63 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| History of abdominal or pelvic surgery | 13 Participants | 22 Participants | 9 Participants |
| Menopausal status | 22 Participants | 50 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 28 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 53 Participants | 24 Participants |
| Region of Enrollment United States | 46 participants | 91 participants | 45 participants |
| Sex: Female, Male Female | 46 Participants | 91 Participants | 45 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Tobacco user | 7 Participants | 7 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 0 / 49 | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
Incidence of Urinary Retention
Incidence of participants that do not pass their voiding trial and go home with an indwelling foley
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pyridium Arm | Incidence of Urinary Retention | 16 Participants |
| Control Arm | Incidence of Urinary Retention | 15 Participants |
Primary
Number of Participants Considered to Have Passed Their Voiding Trial
Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pyridium Arm | Number of Participants Considered to Have Passed Their Voiding Trial | 30 Participants |
| Control Arm | Number of Participants Considered to Have Passed Their Voiding Trial | 30 Participants |
Secondary
Pain Scale
Pain scale from 0-10. 0-being no pain, 10-being the most pain
Time frame: Day 1: 6-8 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pyridium Arm | Pain Scale | 3 score on a scale |
| Control Arm | Pain Scale | 3 score on a scale |