Urinary Retention
Conditions
Keywords
Postoperative care, Urinary tract infection, Female pelvic reconstructive surgery, Enhanced recovery after surgery, Tamsulosin, Flomax
Brief summary
This is a double-blinded randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery undergoing same-day discharge with an enhanced recovery after surgery protocol.
Detailed description
The primary objective is to determine the effect of Tamsulosin on same-day active voiding trial in women undergoing female pelvic reconstructive surgery with vaginal native tissue repair with same-day discharge planned. Duration of catheterization, postoperative urinary tract infection rates, patient level of satisfaction, Emergency Department (ED) visits and adverse events postoperatively will also be compared between women receiving Tamsulosin versus placebo. Patients will be offered participation in the study at their postoperative visit if they meet study criteria. Once consent is obtained, patients will be randomized to receive Tamsulosin 0.4 mg orally once daily or matching placebo capsules for a total of 10 days starting 5 days pre-operatively.
Interventions
DRUGTamsulosin
Oral drug: 10 days of 0.4 mg of oral Tamsulosin
DRUGPlacebo
Oral drug: 10 days of identical-appearing placebo
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Stage II or greater pelvic organ prolapse in \> 1 vaginal compartment * Plan for multicompartment native tissue vaginal repair (which would include any combination of uterosacral ligament suspension, sacrospinous ligament suspension, cystocele and/or rectocele repair, with or without hysterectomy and with or without concomitant mid-urethral sling) or vaginal closure with female pelvic medicine and reconstructive surgery (FPMRS) - trained surgeons at Wake Forest Baptist Health * Participation in Enhanced-Recovery-After-Surgery protocol with plan for same-day hospital discharge * Willing to remain compliant with Investigation Product (IP)
Exclusion criteria
* Intraoperative complication necessitating prolonged bladder drainage or placement of a vaginal pack x 24 hours (patients would exit study after randomization and will be excluded from the per-protocol analysis) * Patients whose surgical plan would necessitate a voiding trial on postop day \>0 * Less than 21 years of age * Unable to understand English * Patients who are scheduled to undergo combined colorectal procedures such as rectopexy, sphincteroplasty * Patient with known allergy to Tamsulosin or sulfa drugs * Patients with upcoming cataract surgery * Patient with orthostatic hypotension * History of postvoid residual (PVR\>150) prior to surgery with prolapse reduction * Patients with hypertension on alpha-blockers * Single compartment prolapse repair (anterior or posterior repair only) * Use of mesh for prolapse repair * High tone pelvic floor dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative (Day 0) Urinary Retention | Up to 6 weeks postoperatively | Urinary retention can be defined as \>150cc residual volume during an active voiding trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Tract Infection Rate | Week 6 | Urinary tract infection rate |
| Incidence of Delayed Urinary Retention | Week 6 | Delayed urinary retention will be defined as post-void residual \> 150 cc |
| Number Emergency Department (ED) Visits | Up to 30 days postoperatively | — |
| Total Number of Days of Bladder Catheterization | Week 6 | — |
| Patient Level of Satisfaction With Voiding Function | Day 0 and 1 week postoperatively | Patient satisfaction questionnaire: Patient Global Impression of Improvement (PGI-I) - Patient level of satisfaction (scale of 1 -7) - very dissatisfied, moderately dissatisfied, slightly dissatisfied, neutral, slightly satisfied, moderately satisfied, very satisfied - the lower the score denotes the more satisfaction) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tamsulosin Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.
Tamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin | 2 |
| Placebo Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.
Placebo: Oral drug: 10 days of identical-appearing placebo | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Tamsulosin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Lost to follow-up | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 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 | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 1 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Number of Participants With Postoperative (Day 0) Urinary Retention
Urinary retention can be defined as \>150cc residual volume during an active voiding trial
Time frame: Up to 6 weeks postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tamsulosin | Number of Participants With Postoperative (Day 0) Urinary Retention | 1 Participants |
| Placebo | Number of Participants With Postoperative (Day 0) Urinary Retention | 1 Participants |
Secondary
Incidence of Delayed Urinary Retention
Delayed urinary retention will be defined as post-void residual \> 150 cc
Time frame: Week 6
Population: No Data was collected
Secondary
Number Emergency Department (ED) Visits
Time frame: Up to 30 days postoperatively
Population: No Data was collected
Secondary
Patient Level of Satisfaction With Voiding Function
Patient satisfaction questionnaire: Patient Global Impression of Improvement (PGI-I) - Patient level of satisfaction (scale of 1 -7) - very dissatisfied, moderately dissatisfied, slightly dissatisfied, neutral, slightly satisfied, moderately satisfied, very satisfied - the lower the score denotes the more satisfaction)
Time frame: Day 0 and 1 week postoperatively
Population: No Data was collected
Secondary
Total Number of Days of Bladder Catheterization
Time frame: Week 6
Population: No Data was collected
Secondary
Urinary Tract Infection Rate
Urinary tract infection rate
Time frame: Week 6
Population: No Data was collected