Urinary RetentionPhase 1/2POURNCT03609580
Post-operative Urinary Retention (POUR) Following Thoracic Surgery
A Phase 1/2 study testing Tamsulosin - 1 week and Tamsulosin - 3 days in people with Urinary Retention, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
Inability to urinate a common complication that happens to many patients after a surgery, especially in men over 60 years of age who undergo surgery on their chest. Urinary retention is uncomfortable, increases anxiety, increases hospital length of stay, and leads to more procedures such as putting in a bladder… Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Tamsulosin - 1 week and Tamsulosin - 3 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 30 Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males
- ≥50 years old Planned surgical procedure of a minimally invasive thoracic surgical procedure (wedge resection, segmentectomy, lobectomy, pleural biopsy, or pleurodesis) Surgery scheduled more than 3 days from the time of consent
Who cannot join
- Using Flomax already
- Allergy to Flomax or sulfa drugs
- Current use of alpha blockers or alpha agonists
- Resting systolic blood pressure <100
- Orthostatic hypotension of >20mm Hg (millimeters of mercury) Systolic and/or 10mm Hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent
- Known diagnosis of congestive heart failure and valvular heart disease
- History of prostate surgery (prostatectomy, trans-urethral resection)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Michael Spallone
Hackensack, New Jersey, 07601
Michael Spallone, MD, 551-996-2000 ext. 5960, michael.spallone@hmhn.org
Michael Spallone, MD
About this study
Inability to urinate a common complication that happens to many patients after a surgery, especially in men over 60 years of age who undergo surgery on their chest. Urinary retention is uncomfortable, increases anxiety, increases hospital length of stay, and leads to more procedures such as putting in a bladder catheter (Foley). This is uncomfortable, and can lead to bleeding, infection, damage to the urethra and/or bladder and bladder spasm. The goal of this study is to attempt to prevent inability to urinate by giving patients a medication called Flomax (Tamusolin) every day beginning a week before surgery. That medication relaxes the prostate. It's approved by the Food and Drug Administration (FDA) to improve urinary flow in those with enlarged prostates. It is also commonly used in patients with bladder problems due to inability to urinate who have required a Foley.
Read the detailed description
Post-operative urinary retention (POUR) in older men who undergo a thoracic surgical procedure occurs in a significant proportion of patients (25% at Hackensack University Medical Center in men >60) and is a significant management problem. Typically, this complication needs to be treated with placement of a bladder catheter (foley). In addition to the discomfort of placing a foley in an awake patient, these patients are at a significantly increased risk of a catheter associated urinary tract infection (CAUTI), potential genito-urinary injury during the placement, and bladder muscle damage due to distention.
The goal of this study is to investigate whether the use of Tamusolin could lower the high incidence of POUR in older men undergoing a thoracic surgical procedure.
The investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 1 week), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure.
- Conditions
- Urinary Retention
- Being tested
- Tamsulosin - 1 week, Tamsulosin - 3 days
- Keywords
- post operative urinary retention, inability to urinate, urinary retentions, lung cancer, VATs, Robotic Lung Surgery, lung resections
- Medical subject headings
- Urinary Retention, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin - 1 weekDrug
The investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 1 week), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure.
Tamsulosin - 3 daysDrug
The investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 3 days), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| 1 week Pre-operative Tamsulosin administration | Experimental | Not described Receives: Drug: Tamsulosin - 1 week |
| 3 days Pre-operative Tamsulosin administration | Experimental | Not described Receives: Drug: Tamsulosin - 3 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of urine (cc) post thoracic surgery in patients that received Flomax, 0.4mg/day for a week before surgery
The absence of voiding naturally after undergoing thoracic surgery needing an intervention as a Foley catheter or a catheterization. Documentation for first void, Post bladder scan showing more that 300cc of residual urine in the bladder (failure to urinate), or following spontaneous urination if there is more than 300cc of residual urine in the bladder (inadequate urination)
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start7 May 2018
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Spallone, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609580
- Sponsor's protocol ID
- PRO#2017-0687
- Acronym
- POUR
- Status last verified
- Jun 2026
- First submitted
- 12 Jul 2018
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Urinary Retention (POUR) Following Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03609580
- Acronym / sponsor ID
- POUR / PRO#2017-0687
- Conditions
- Urinary Retention
- Keywords
- post operative urinary retention, inability to urinate, urinary retentions, lung cancer, VATs, Robotic Lung Surgery, lung resections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inability to urinate a common complication that happens to many patients after a surgery, especially in men over 60 years of age who undergo surgery on their chest. Urinary retention is uncomfortable, increases anxiety, increases hospital length of stay, and leads to more procedures such as putting in a bladder catheter (Foley). This is uncomfortable, and can lead to bleeding, infection, damage to the urethra and/or bladder and bladder spasm. The goal of this study is to attempt to prevent inability to urinate by giving patients a medication called Flomax (Tamusolin) every day beginning a week before surgery. That medication relaxes the prostate. It's approved by the Food and Drug Administration (FDA) to improve urinary flow in those with enlarged prostates. It is also commonly used in patients with bladder problems due to inability to urinate who have required a Foley.
Detailed description
Post-operative urinary retention (POUR) in older men who undergo a thoracic surgical procedure occurs in a significant proportion of patients (25% at Hackensack University Medical Center in men >60) and is a significant management problem. Typically, this complication needs to be treated with placement of a bladder catheter (foley). In addition to the discomfort of placing a foley in an awake patient, these patients are at a significantly increased risk of a catheter associated urinary tract infection (CAUTI), potential genito-urinary injury during the placement, and bladder muscle damage due to distention.
The goal of this study is to investigate whether the use of Tamusolin could lower the high incidence of POUR in older men undergoing a thoracic surgical procedure.
The investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 1 week), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 week Pre-operative Tamsulosin administration | Experimental | Drug: Tamsulosin - 1 week |
| 3 days Pre-operative Tamsulosin administration | Experimental | Drug: Tamsulosin - 3 days |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males
- ≥50 years old Planned surgical procedure of a minimally invasive thoracic surgical procedure (wedge resection, segmentectomy, lobectomy, pleural biopsy, or pleurodesis) Surgery scheduled more than 3 days from the time of consent
Key exclusion criteria (7 listed)
- Using Flomax already
- Allergy to Flomax or sulfa drugs
- Current use of alpha blockers or alpha agonists
- Resting systolic blood pressure <100
- Orthostatic hypotension of >20mm Hg (millimeters of mercury) Systolic and/or 10mm Hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamsulosin - 1 weekThe investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 1 week), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure. | Drug | 1 week Pre-operative Tamsulosin administration |
| Tamsulosin - 3 daysThe investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 3 days), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure. | Drug | 3 days Pre-operative Tamsulosin administration |
Primary outcome
Volume of urine (cc) post thoracic surgery in patients that received Flomax, 0.4mg/day for a week before surgery
Time frame: 8 hours
The absence of voiding naturally after undergoing thoracic surgery needing an intervention as a Foley catheter or a catheterization. Documentation for first void, Post bladder scan showing more that 300cc of residual urine in the bladder (failure to urinate), or following spontaneous urination if there is more than 300cc of residual urine in the bladder (inadequate urination)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Urinary Retention
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Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention
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Pelvic Health Electrically Evoked Recording (PEER) 2 Study
Overactive Bladder, Fecal Incontinence
Not yet recruitingObservational study
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
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Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Spallone, MD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tamsulosin - 1 week and Tamsulosin - 3 days in people with Urinary Retention, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Spallone, MD (551-996-2000 ext. 5960, michael.spallone@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of urine (cc) post thoracic surgery in patients that received Flomax, 0.4mg/day for a week before surgery (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.