Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention

• Sponsor: University of Rochester (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02684344
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This randomized open-label study will be comprised of 2 cohorts: one control group and one treatment group. The trial will be conducted as an open label randomized trial to evaluate the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study will include pre- and post-surgical evaluations of patients including symptoms of urinary retention and any adverse effects contributable to the study medication.

Condition or Disease	Intervention/Treatment	Phase
Post-Operative Urinary Retention	Drug: Tamsulosin; Other: Education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention
• Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tamsulosin Group Subjects will receive: 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery education about signs and symptoms of urinary retention	Drug: Tamsulosin; Tamsulosin may have prophylactic properties against post-operative urinary retention; Other Names: Flomax ; Other: Education; Education about signs and symptoms of urinary retention
Active Comparator: Education Group Subjects will receive: 1) education about signs and symptoms of urinary retention	Other: Education; Education about signs and symptoms of urinary retention

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Post-operative Urinary Retention [5 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Any male age 40 or older

• Scheduled to undergo one of the planned surgeries (thoracic, general, or urologic)

• Ability to give informed consent

Exclusion Criteria:

• Current use of alpha blocker

• Current use of a strong CYP 3A4 inhibitors

• Any allergy to tamsulosin, alpha-blocker medication class, or anaphylaxis allergy to sulfate containing medications

• Patients with any upcoming surgery for cataracts

• Currently enrolled in a clinical trial

• Inability to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester

Investigators

• Principal Investigator: Edward E. Messing, MD, University of Rochester

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 9, 2016

More Information

Publications

None provided.

• Responsible Party: Edward Messing, Principal Investigator, University of Rochester
• ClinicalTrials.gov Identifier: NCT02684344
• Other Study ID Numbers: 59730
• First Posted: Feb 18, 2016
• Last Update Posted: Jan 23, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Edward Messing, Principal Investigator, University of Rochester: Post-Operative Urinary Retention
• Additional relevant MeSH terms: Urinary Retention; Tamsulosin

Study Results

Participant Flow

Arm/Group Title	Tamsulosin Group	Education Group
Arm/Group Description	Subjects will receive: 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery education about signs and symptoms of urinary retention Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention Education: Education about signs and symptoms of urinary retention	Subjects will receive: 1) education about signs and symptoms of urinary retention Education: Education about signs and symptoms of urinary retention
Period Title: Overall Study
STARTED	1	4
COMPLETED	1	3
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Tamsulosin Group	Education Group	Total
Arm/Group Description	Subjects will receive: 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery education about signs and symptoms of urinary retention Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention Education: Education about signs and symptoms of urinary retention	Subjects will receive: 1) education about signs and symptoms of urinary retention Education: Education about signs and symptoms of urinary retention	Total of all reporting groups
Overall Participants	1	4	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	3 75%	3 60%
>=65 years	1 100%	1 25%	2 40%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	1 100%	4 100%	5 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	1 100%	4 100%	5 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	1 100%	4 100%	5 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%	4 100%	5 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Post-operative Urinary Retention
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin Group	Education Group
Arm/Group Description	Subjects will receive: 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery education about signs and symptoms of urinary retention Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention Education: Education about signs and symptoms of urinary retention	Subjects will receive: 1) education about signs and symptoms of urinary retention Education: Education about signs and symptoms of urinary retention
Measure Participants	1	4
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	1 month
Arm/Group Title	Tamsulosin Group		Education Group
Arm/Group Description	Subjects will receive: 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery education about signs and symptoms of urinary retention Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention Education: Education about signs and symptoms of urinary retention		Subjects will receive: 1) education about signs and symptoms of urinary retention Education: Education about signs and symptoms of urinary retention
All Cause Mortality
	Tamsulosin Group		Education Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/4 (0%)
Serious Adverse Events
	Tamsulosin Group		Education Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Tamsulosin Group		Education Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.