Lower Urinary Tract Symptoms, Pelvic Organ Prolapse, Stress Urinary Incontinence, Urinary Retention
Conditions
Brief summary
This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.
Interventions
DRUGPlacebo oral capsule
Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
DRUGTamsulosin
Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients must be 18 years or older as well as willing and able to provide informed consent * Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence * Standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1.
Exclusion criteria
* Patient unable or unwilling to provide informed consent * Severe allergy to sulfa drugs * Known allergy to tamsulosin or another alpha antagonist medication * History of urinary retention * Planned bladder catheterization greater than 24 hours after surgery * Current use of alpha antagonist medication for hypertension * End stage renal or liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Urinary Retention | Within 72 hours of surgery | Failed voiding trial upon removal of catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score | Within 1 week of surgery | Total and subscale scores reported. Total score range 0-35, with 0 being less symptomatic and 35 being more symptomatic. Total score is sum of individual questions. Seven subgroups address incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia. Each subgroup is scored 0-5 with 5 being most symptomatic. The last question is independent, rates quality of life from 0 (best) to 6 (worst) |
| Postoperative Urinary Tract Infection | Within 6 weeks after surgery | Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection. |
| Sent Home With Catheterization | within 6 weeks of surgery | Urinary retention that required homegoing catheterization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo oral capsule: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention. | 57 |
| Tamsulosin Tamsulosin: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention. | 62 |
| Total | 119 |
Baseline characteristics
| Characteristic | Placebo | Total | Tamsulosin |
|---|---|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 10.9 | 61.3 years STANDARD_DEVIATION 10.3 | 61.0 years STANDARD_DEVIATION 9.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 14 Participants | 6 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 | 47 Participants | 103 Participants | 56 Participants |
| Region of Enrollment United States | 57 participants | 119 participants | 62 participants |
| Sex: Female, Male Female | 57 Participants | 119 Participants | 62 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 / 62 | 0 / 57 |
| other Total, other adverse events | 3 / 62 | 3 / 57 |
| serious Total, serious adverse events | 2 / 62 | 1 / 57 |
Outcome results
Primary
Postoperative Urinary Retention
Failed voiding trial upon removal of catheter
Time frame: Within 72 hours of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Postoperative Urinary Retention | 16 Participants |
| Tamsulosin | Postoperative Urinary Retention | 5 Participants |
Secondary
International Prostate Symptom Score
Total and subscale scores reported. Total score range 0-35, with 0 being less symptomatic and 35 being more symptomatic. Total score is sum of individual questions. Seven subgroups address incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia. Each subgroup is scored 0-5 with 5 being most symptomatic. The last question is independent, rates quality of life from 0 (best) to 6 (worst)
Time frame: Within 1 week of surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | International Prostate Symptom Score | 6 Points |
| Tamsulosin | International Prostate Symptom Score | 7 Points |
Secondary
Postoperative Urinary Tract Infection
Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection.
Time frame: Within 6 weeks after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Postoperative Urinary Tract Infection | 6 Participants |
| Tamsulosin | Postoperative Urinary Tract Infection | 4 Participants |
Secondary
Sent Home With Catheterization
Urinary retention that required homegoing catheterization
Time frame: within 6 weeks of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Sent Home With Catheterization | 7 Participants |
| Tamsulosin | Sent Home With Catheterization | 5 Participants |