Trial Outcomes & Findings for Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin (NCT NCT04994431)

NCT ID: NCT04994431

Last Updated: 2024-11-07

Results Overview

Proportion of Participants experiencing Post-Operative Urinary Retention (POUR) following thoracic surgery as compared to historic controls.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 109 participants
• Primary outcome timeframe: 5 days
• Results posted on: 2024-11-07

Participant Flow

Participant milestones

Measure	Perioperative Tamsulosin Hydrochloride Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery. Tamsulosin Hydrochloride: 0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.	Historical Comparator Participants who underwent thoracic surgery (historical). Information about occurrence of Peri-Operative Urinary Retention in thoracic surgery patients will be obtained via retrospective chart review.
Overall Study STARTED	8	101
Overall Study COMPLETED	7	101
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Perioperative Tamsulosin Hydrochloride Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery. Tamsulosin Hydrochloride: 0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.	Historical Comparator Participants who underwent thoracic surgery (historical). Information about occurrence of Peri-Operative Urinary Retention in thoracic surgery patients will be obtained via retrospective chart review.
Overall Study Adverse Event	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Perioperative Tamsulosin Hydrochloride n=7 Participants Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery. Tamsulosin Hydrochloride: 0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.	Historical Comparator n=101 Participants Participants who underwent thoracic surgery (historical). Information about occurrence of Peri-Operative Urinary Retention in thoracic surgery patients will be obtained via retrospective chart review.	Total n=108 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=101 Participants	0 Participants n=108 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=7 Participants	27 Participants n=101 Participants	29 Participants n=108 Participants
Age, Categorical >=65 years	5 Participants n=7 Participants	74 Participants n=101 Participants	79 Participants n=108 Participants
Age, Continuous	70 years STANDARD_DEVIATION 8 • n=7 Participants	70 years STANDARD_DEVIATION 7 • n=101 Participants	70 years STANDARD_DEVIATION 7 • n=108 Participants
Sex: Female, Male Female	0 Participants n=7 Participants	0 Participants n=101 Participants	0 Participants n=108 Participants
Sex: Female, Male Male	7 Participants n=7 Participants	101 Participants n=101 Participants	108 Participants n=108 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	7 participants n=7 Participants	101 participants n=101 Participants	108 participants n=108 Participants

PRIMARY outcome

Timeframe: 5 days

Proportion of Participants experiencing Post-Operative Urinary Retention (POUR) following thoracic surgery as compared to historic controls.

Outcome measures

Measure	Perioperative Tamsulosin Hydrochloride n=7 Participants Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery. Tamsulosin Hydrochloride: 0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.	Historical Comparator n=101 Participants Participants who underwent thoracic surgery (historical). Information about occurrence of Peri-Operative Urinary Retention in thoracic surgery patients will be obtained via retrospective chart review.
Participants With Post-Operative Urinary Retention (Pour)	1 participants	32 participants

Adverse Events

Perioperative Tamsulosin Hydrochloride

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Historical Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Perioperative Tamsulosin Hydrochloride n=7 participants at risk Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery. Tamsulosin Hydrochloride: 0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.	Historical Comparator n=101 participants at risk Participants who underwent thoracic surgery (historical). Information about occurrence of Peri-Operative Urinary Retention in thoracic surgery patients will be obtained via retrospective chart review.
Respiratory, thoracic and mediastinal disorders Aspiration	14.3% 1/7 • Number of events 1 • 5 Days	0.00% 0/101 • 5 Days

Other adverse events

Adverse event data not reported

Additional Information

Feiran Lou

UMass Memorial Health Care

Phone: 5083348996

Email: feiran.lou@umassmemorial.org

Results disclosure agreements

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