Clinical trial NCT05657990: Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery
Official title: Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Urinary Retention
Keywords: Urinary Retention
post surgery Urinary Retention
thoracic surgery
spontaneous voiding
bladder retention
Tamsulosin (FlomaxTM)
kidney injury
men undergoing thoracic oncological surgical procedure
BladderScanner
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 46
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants that were able to spontaneously void after surgery completion
timeFrame: 6-8 hours post operative
measure: Time of the void
timeFrame: Within 24 hours post operative
measure: Volume of urine
timeFrame: Within 24 hours post operative
measure: Amount of residual urine
timeFrame: Within 24 hours post operative
measure: Number of participants that needed an intervention due to failure to spontaneously urinate
timeFrame: Within 24 hours post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Brick
country: United States
facility: Ocean University Medical Center
state: New Jersey
city: Manahawkin
country: United States
facility: South Ocean University Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Thomas Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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