Urinary Retention Clinical Trial
Official title:
A Randomized Control Trial Assessing Pyridium for Post-Sling Urinary Retention
Verified date | October 2019 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | July 1, 2019 |
Est. primary completion date | July 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Day 1 | |
Primary | Incidence of Urinary Retention | Incidence of participants that do not pass their voiding trial and go home with an indwelling foley | Day 1 | |
Secondary | Pain Scale | Pain scale from 0-10. 0-being no pain, 10-being the most pain | Day 1: 6-8 hours after surgery |
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