Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery

Sponsor

Hackensack Meridian Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05657990

Collaborator

(none)

Enrollment

Locations

Arm

46.4

Anticipated Duration (Months)

11.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a feasibility study looking at whether the use of Tamsulosin could lower the high incidence of postoperative urinary retention (POUR) in older men who undergo an oncological thoracic surgical procedure for suspected or confirmed cancer. In addition, the study will try to identify the time of resumption of presurgical urinary function post Tamsulosin administration.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention	Drug: Tamsulosin	Early Phase 1

Detailed Description

Post-operative urinary retention (POUR) is a significant problem in post-operative patients. The incidence varies, but can reach up to 70%, which most commonly affects older men with enlarged prostates. Even after adjusting for the modifiable risk factors, such as decreased intraoperative foley use and post-operative narcotic use, the incidence remains high. This causes an increase in urinary tract infections, patient discomfort, longer hospital stays, and occasionally further urologic complications. Studies have shown that the use of tamsulosin, an alpha1-adrenergic receptor blocker, may decrease the incidence of POUR by improving urinary flow via relaxation of the smooth muscle tissue. Therefore, the goal of our study is to investigate whether Tamsulosin (Flomax) can be used to lower incidence of POUR in older men undergoing an oncological thoracic surgical procedure.

This is a pilot/feasibility/ early efficacy study to determine if treating men > 55 years of age with Tamsulosin prior to a thoracic oncological surgery will prevent postoperative urinary retention (POUR).

Subjects will be provided with a prescription for Tamsulosin (generic) to be taken 7 days prior to scheduled surgery. For research purposes, post-surgical spontaneous voids will be measured, and any residual urine in the bladder will be assessed and measured using a BladderScanner. This data will be used to determine postoperative urinary retention (POUR). Additionally, standard of care bladder management will be used if the subject did not spontaneously void or had excess urine residual. The algorithm in the table below will guide bladder management decisions.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery

Anticipated Study Start Date :

Jan 20, 2023

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pre-operative Tamsulosin administration Subjects will be provided with a prescription for Tamsulosin (generic) to be taken 7 days prior to scheduled surgery for thoracic cancer. Tamsulosin dose is set at 0.4mg/day and should be taken daily for seven days prior to their planned surgery date. Study subjects will also be given a diary to record their daily usage. Study subjects should take Tamsulosin on the day of the surgery with a sip of water.	Drug: Tamsulosin Tamsulosin 0.4 mg one time daily after a meal for seven days prior to surgery. Post-surgery, an ultrasound of the bladder will be completed approximately six hours after surgery to assess the bladder. If the bladder ultrasound shows more than 400 cc of urine in the bladder, or if the study subject passes urine on his own and there is more than 100cc or less than 400 cc of urine left in the bladder, he will be encouraged to try to pass urine. Study subject will be monitored for two additional hours. If a study subject is unable to pass urine at this time or the bladder has 400 cc or more of urine left in it, he will have an intermittent catheter (in and out) to drain urine. If the bladder has greater than 500 cc (which is approximately 16 and two-thirds ounces) per catheterization for more than 24 hours, and the study subject cannot pass urine, an indwelling catheter may be considered. Other Names: Flomax

Arm

Intervention/Treatment

Experimental: Pre-operative Tamsulosin administration

Subjects will be provided with a prescription for Tamsulosin (generic) to be taken 7 days prior to scheduled surgery for thoracic cancer. Tamsulosin dose is set at 0.4mg/day and should be taken daily for seven days prior to their planned surgery date. Study subjects will also be given a diary to record their daily usage. Study subjects should take Tamsulosin on the day of the surgery with a sip of water.

Drug: Tamsulosin

Tamsulosin 0.4 mg one time daily after a meal for seven days prior to surgery. Post-surgery, an ultrasound of the bladder will be completed approximately six hours after surgery to assess the bladder. If the bladder ultrasound shows more than 400 cc of urine in the bladder, or if the study subject passes urine on his own and there is more than 100cc or less than 400 cc of urine left in the bladder, he will be encouraged to try to pass urine. Study subject will be monitored for two additional hours. If a study subject is unable to pass urine at this time or the bladder has 400 cc or more of urine left in it, he will have an intermittent catheter (in and out) to drain urine. If the bladder has greater than 500 cc (which is approximately 16 and two-thirds ounces) per catheterization for more than 24 hours, and the study subject cannot pass urine, an indwelling catheter may be considered.

Other Names:

Flomax

Outcome Measures

Primary Outcome Measures

Number of participants that were able to spontaneously void after surgery completion [6-8 hours post operative]
Self-reported void within 6-8 hours post operative
Time of the void [Within 24 hours post operative]
Time (number of minutes) to first postoperative spontaneous urination post operation
Volume of urine [Within 24 hours post operative]
Volume of urine during the first postoperative spontaneous urination post operation.
Amount of residual urine [Within 24 hours post operative]
Patients will receive a bladder scan post their first postoperative spontaneous urination and the amount of residual urine will be measured.
Number of participants that needed an intervention due to failure to spontaneously urinate [Within 24 hours post operative]
Patients that did not spontaneously urinate within 6-8 hours post operative will have an intervention. Potential interventions include : a) Prompted voiding and rescanning in 2 hours; b) Intermittent catheterization and patient prompting; c) Indwelling catheter inserted.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Males
≥55 years old
Planned thoracic oncological surgical procedure of a video assisted oncological surgical procedure for suspected or confirmed cancer.
Surgery scheduled more than 7 days from the time of consent

Exclusion Criteria:

Using Tamsulosin already
Known allergy to Tamsulosin or sulfa drugs
Current use of Boceprevir
Resting systolic blood pressure <100
Orthostatic hypotension of >20mm Hg systolic and/or 10mm Hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent
Known history of hypotension
Known diagnosis of congestive heart failure (CHF) and valvular heart disease
History of prior prostate surgery (prostatectomy, trans-urethral resection)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ocean University Medical Center	Brick	New Jersey	United States	08724
2	South Ocean University Medical Center	Manahawkin	New Jersey	United States	08050
3	Jersey Shore University Medical Center	Neptune	New Jersey	United States	07753
4	Riverview Medical Center	Red Bank	New Jersey	United States	07701