Trial Outcomes & Findings for Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery (NCT NCT03524339)

NCT ID: NCT03524339

Last Updated: 2021-11-08

Results Overview

Failed voiding trial upon removal of catheter

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 132 participants
• Primary outcome timeframe: Within 72 hours of surgery
• Results posted on: 2021-11-08

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	66	66
Overall Study COMPLETED	57	62
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery

Baseline characteristics by cohort

Measure	Placebo n=57 Participants 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.	Tamsulosin n=62 Participants 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.	Total n=119 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 10.9 • n=93 Participants	61.0 years STANDARD_DEVIATION 9.7 • n=4 Participants	61.3 years STANDARD_DEVIATION 10.3 • n=27 Participants
Sex: Female, Male Female	57 Participants n=93 Participants	62 Participants n=4 Participants	119 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Race (NIH/OMB) White	47 Participants n=93 Participants	56 Participants n=4 Participants	103 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	57 participants n=93 Participants	62 participants n=4 Participants	119 participants n=27 Participants

PRIMARY outcome

Timeframe: Within 72 hours of surgery

Failed voiding trial upon removal of catheter

Outcome measures

Measure	Placebo n=62 Participants 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.	Tamsulosin n=57 Participants 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.
Postoperative Urinary Retention	16 Participants	5 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Placebo n=37 Participants 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.	Tamsulosin n=35 Participants 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.
International Prostate Symptom Score	6 Points Interval 3.0 to 12.5	7 Points Interval 3.0 to 11.0

SECONDARY outcome

Timeframe: Within 6 weeks after surgery

Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection.

Outcome measures

Measure	Placebo n=62 Participants 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.	Tamsulosin n=57 Participants 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.
Postoperative Urinary Tract Infection	6 Participants	4 Participants

SECONDARY outcome

Timeframe: within 6 weeks of surgery

Urinary retention that required homegoing catheterization

Outcome measures

Measure	Placebo n=62 Participants 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.	Tamsulosin n=57 Participants 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.
Sent Home With Catheterization	7 Participants	5 Participants

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Tamsulosin

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=62 participants at risk 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.	Tamsulosin n=57 participants at risk 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.
Cardiac disorders Development of atrial fibrillation	0.00% 0/62 • Three days prior to surgery through five days after surgery (10d total)	1.8% 1/57 • Three days prior to surgery through five days after surgery (10d total)
Respiratory, thoracic and mediastinal disorders Pulmonary edema	1.6% 1/62 • Three days prior to surgery through five days after surgery (10d total)	0.00% 0/57 • Three days prior to surgery through five days after surgery (10d total)
Cardiac disorders Congestive heart failure	1.6% 1/62 • Three days prior to surgery through five days after surgery (10d total)	0.00% 0/57 • Three days prior to surgery through five days after surgery (10d total)

Other adverse events

Measure	Placebo n=62 participants at risk 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.	Tamsulosin n=57 participants at risk 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.
Nervous system disorders Dizziness/lightheadedness	4.8% 3/62 • Three days prior to surgery through five days after surgery (10d total)	5.3% 3/57 • Three days prior to surgery through five days after surgery (10d total)

Additional Information

Graham Chapman

Cleveland Clinic

Phone: 440-312-2229

Email: gchapman5@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place