Urinary Retention Postoperative
Conditions
Brief summary
The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial.
Detailed description
The primary objective is to determine the impact of Tamsulosin on duration of urinary retention following pelvic reconstructive surgery in women. Duration of catheterization via indwelling foley or clean intermittent self-catheterization (CISC), measured in days, will be compared between women receiving Tamsulosin versus placebo after diagnosis of postoperative urinary retention via standardized voiding trial. It is hypothesized that women receiving Tamsulosin will have a shorter duration of urinary retention, fewer urinary tract infections, and improved quality of life as compared with placebo. The Euroqol-5D (EQ-5D) will be used to compare physical, emotional, functional, and social/family well-being between women receiving Tamsulosin and placebo. Upon diagnosis of POUR, women will be offered participation in the study. Once consent is obtained, women will be randomized to tamsulosin 0.4 mg or matching placebo capsules to be used daily until resolution of POUR or a 10 day course, whichever occurs first.
Interventions
DRUGTamsulosin
Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.
DRUGPlacebo
Placebo will be prepared by the IDS pharmacist (or contracted pharmacy) and encapsulated in identical appearing wraps. Subjects will be provided with 10 capsules to be taken daily.
Sponsors
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older * willing and able to provide informed consent * postoperative urinary retention as defined by a failed RGVT prior to hospital discharge * Ability to speak and read English * Tolerate pill ingestion
Exclusion criteria
* allergy/intolerance to Tamsulosin or sulfa drugs * preoperative history of urinary retention as defined by preoperative post void residual of \>150mL * current use of alpha antagonist medication for hypertension * severe dementia * end stage renal or liver disease * history of severe heart failure or major cardiovascular event in the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the impact of Tamsulosin on duration of urinary retention | Date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course | The primary outcome is duration of postoperative urinary retention measured in days following failed retrograde voiding trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the impact of Tamsulosin on rates of urinary tract infection (UTI). | Date of failed the retrograde voiding trial and up to 6 weeks. | The electronic medical record (EMR) will be reviewed to determine if subjects were treated for a urinary tract infection (UTI). UTIs will be diagnosed by a urine culture confirming bacteriuria of at least 10 \^5 CFU/mL. UTIs treated presumptively and without culture will also be included as positive cultures. |
| To quantify the effect of Tamsulosin on patient quality of life. | Prior to discharge and again at 2 weeks follow up | Patients will be asked to complete the Euroqol-5D (EQ-5D) questionnaire to assess quality of life. The EQ-5D is scored with a 5-digit code of index values which reflect how good or bad a health state is (Level 1 indicates no problem where is Level 5 indicates extreme problems). |
Countries
United States
Contacts
CONTACTLindsay Turner
CONTACTAHN Clinical Trials Contact
PRINCIPAL_INVESTIGATORLindsay Turner, MD
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Outcome results
None listed