Urinary RetentionPhase 3POURNCT02486653
Prevention of Post-operative Urinary Retention
A Phase 3 study testing Tamsulosin in people with Urinary Retention and Urinary Tract Infections, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to determine if tamsulosin ("FLOMAX") is effective in preventing post-operative urinary retention following abdominal surgery. Post-operative urinary retention is a common post-operative complication, occurring in up to 30% of patients undergoing abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Retention, Urinary Tract Infections
- What is being tested?
- Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 2 May 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Able to provide informed consent
- Scheduled to undergo an elective, complex intra-abdominal operation with a planned postoperative inpatient stay of at least 1 night
Who cannot join
- Less than age 18
- Allergy or contraindication to tamsulosin
- Serious sulfa allergy
- Current use of alpha blocker (alfuzosin, doxazosin, prazosin, silodosin, terazosin, verapamil, tamsulosin) or oral alpha agonist (midodrine), or initiation of one of these medications during the intervention phase of the study will result in subject withdrawal from the study
- Current warfarin use
- Pre-existing indwelling urinary catheter, suprapubic catheter, or urostomy
Show all 15Show fewer
- End stage renal disease or dialysis-dependence
- Sitting systolic blood pressure in the upper extremity of less than 100mm Hg at time of eligibility screening
- Presence of orthostatic hypotension at the time of eligibility screening (orthostatic hypotension is defined as a drop in systolic blood pressure of 20mm Hg from sitting to standing, or drop in diastolic BP of 10 mm Hg from sitting to standing after 2-3 minutes of standing after being in a sitting position)
- Anticipated inability to take oral medications on post-operative day #0
- Anticipated requirement for indwelling urinary catheter beyond post-operative day #2
- Non-English speaking
- Pregnant or breast-feeding
- Unwillingness to answer all 7 questions on the IPSS (International Prostate Symptom Score) survey
- Lacking capacity to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: Pre-operative Tamsulosin for the Prevention of Post-operative Urinary Retention: a Randomized, Double-blind, Placebo-controlled Trial
The purpose of this study is to determine if tamsulosin ("FLOMAX") is effective in preventing post-operative urinary retention following abdominal surgery. Post-operative urinary retention is a common post-operative complication, occurring in up to 30% of patients undergoing abdominal surgery. It can be described as the inability to initiate urination or properly empty one's bladder following surgery. It is usually self-limited, but it requires the use of catheterization to empty the bladder in order to prevent further injury to the bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a medication that is commonly used in men with urinary symptoms related to an enlarged prostate. There is some evidence to suggest that it may also potentially be beneficial for preventing post-operative urinary retention. Therefore, in this research study, subjects scheduled for abdominal surgery will be randomly assigned to take either tamsulosin once-daily or placebo once-daily for one week leading up to surgery, and up to several days after surgery. Urinary function will be assessed and compared between these two treatments. The hypothesis is that tamsulosin will reduce the rate of postoperative urinary retention compared to placebo.
Read the detailed description
Postoperative urinary retention (POUR) complicates up to 30% of general abdominal operations. It results in patient discomfort, embarrassment, interference with therapies, and significant nursing burden. More importantly, urinary retention necessitates use of intermittent catheterization or placement of an indwelling urinary catheter, which exposes the patient to an increased risk of urinary tract infection (UTI), urethral injury, and potentially increased hospital length of stay and cost. For these reasons, a safe and effective intervention for preventing POUR would be highly valuable. Despite such a need, no contemporary studies exist evaluating medications that can be used to prevent POUR in broad general surgery populations. To address this gap, the investigators have designed a prospective, randomized, double-blind, placebo-controlled trial to test the hypothesis that preoperative loading with tamsulosin will prevent POUR in patients undergoing elective, inpatient complex intra-abdominal surgery and thereby lead to improved short-term outcomes.
Tamsulosin is a safe and widely-used selective alpha-1-A adrenergic blocker commonly used for the treatment of lower urinary tract symptoms in men with benign prostatic hypertrophy. It has also been shown to have some benefit in reducing POUR and need for catheterization in men undergoing inguinal hernia repair and other outpatient urologic procedures. This study is a randomized, double-blind, placebo-controlled trial in which patients scheduled for inpatient complex intra-abdominal surgery will be randomized to receive either tamsulosin or placebo for 7 days pre-operatively, and up to several days post-operatively, and then rates of POUR will be compared between the two groups (Aim 1). A retrospective analysis of the data will be used to identify risk factors for POUR and subgroups of patients that would derive the greatest benefit from preoperative tamsulosin (Aim 2). Furthermore, short-term outcomes, including rate of urinary tract infection (UTI) and hospital length of stay, will be compared between the tamsulosin and placebo groups (Aim 3).
Enrolled subjects will be randomized using a blocked, stratified randomization process to either tamsulosin or placebo. Stratification variables include gender, pelvic vs non-pelvic surgery, and International Prostate Symptom Score (IPSS) survey results (which is a measure of baseline lower urinary tract symptoms). After a 7-day treatment period, subjects will undergo surgery as scheduled, and then the assigned treatment will be continued for up to a total of 14 days until the subject either has return of normal voiding function, has required replacement of an indwelling urinary catheter, or is discharged from the hospital.
- Conditions
- Urinary Retention, Urinary Tract Infections
- Being tested
- Tamsulosin, Placebo
- Keywords
- tamsulosin, randomized controlled trials as topic, double-blind method, random allocation, placebos, Adrenergic alpha-Antagonists, urinary retention, urinary tract infections, urinary catheters, catheter-related infections, postoperative complications
- Medical subject headings
- Urinary Retention, Urinary Tract Infections, Catheter-Related Infections, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Flomax
Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
Outline of schedule:
- Day 1-7: tamsulosin 0.4mg in the evening
- Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol
- Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual <200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.
PlaceboDrug
Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
Outline of schedule:
- Day 1-7: placebo in the evening
- Day 8: surgery; placebo in the evening if the subject has not yet completed the bladder management protocol
- Day 9-14: placebo in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual <200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Experimental | Not described Receives: Drug: Tamsulosin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome
need for any intermittent catheterization after leaving the operating room or after initial indwelling urinary catheter (IUC) removal; subjects will be straight catheterized if the subject either 1) reports bladder discomfort, or 2) has a bladder scan for >500milliliters; or 3) has a post-void residual volume >500milliliters
Measured: within 0-7 days after surgery
Secondary outcomes (8)
Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome
Need for replacement of an IUC after surgery or after initial removal of an IUC that was placed at the time of surgery; replacement of IUC is dictated by the institutional bladder management protocol after requiring the use of straight catheterization for 24 hours
Measured: within 0-7 days after surgery
Time Until First Spontaneous Void
time from IUC removal, last intermittent catheterization (if performed in the operating room or post-anesthesia care unit), or departure from the operating room (if no IUC placed intraoperatively) until first spontaneous void
Measured: within 0-7 days after surgery
Total Number of Intermittent Catheterizations Required Per Subject
total number of intermittent catheterizations required, as dictated by the institutional bladder management protocol
Measured: within 0-7 days after surgery
First Post-void Residual Urine Volume
The post-void residual (PVR) urine volume as measured by bedside hand-held bladder scanning immediately following the first spontaneous void
Measured: within 0-7 days after surgery
Discharge From Hospital With Indwelling Urinary Catheter
Does the subject have a urinary catheter in place at the time of discharge from the hospital? This is a binary outcome measure of whether or not the subject is discharged from the hospital with an indwelling urinary catheter in place due to inadequate voiding function.
Measured: up to 30 days after surgery
Urinary Tract Infection (UTI)
Either a culture-positive UTI prior to discharge from the hospital or subject self-reported clinician-diagnosed UTI occurring within 30 days of surgery
Measured: up to 30 days after surgery
Hospital Length of Stay in Days
Collected after the participant is discharged from the hospital, total number of consecutive days (including day of surgery) until the participant is discharged from the hospital
Measured: up to 30 days after surgery
Number of Participants Who Experienced Adverse Events
Adverse events, systematically collected. Summary results reported here, please refer to Adverse Events section of the results record for detailed reporting.
Measured: treatment day 1 (7 days before surgery) until 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion1 Apr 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evie H Carchman, MD, Principal investigator, University of Wisconsin - Madison School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486653
- Sponsor's protocol ID
- 2014-1494
- Acronym
- POUR
- Status last verified
- Sep 2019
- First submitted
- 25 Jun 2015
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Buckley BS, Lapitan MC. Drugs for treatment of urinary retention after surgery in adults. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD008023. doi: 10.1002/14651858.CD008023.pub2.
PubMed 20927768Choi S, Awad I. Maintaining micturition in the perioperative period: strategies to avoid urinary retention. Curr Opin Anaesthesiol. 2013 Jun;26(3):361-7. doi: 10.1097/ACO.0b013e32835fc8ba.
PubMed 23492981Lo E, Nicolle LE, Coffin SE, Gould C, Maragakis LL, Meddings J, Pegues DA, Pettis AM, Saint S, Yokoe DS. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 May;35(5):464-79. doi: 10.1086/675718. No abstract available.
PubMed 24709715Hollingsworth JM, Rogers MA, Krein SL, Hickner A, Kuhn L, Cheng A, Chang R, Saint S. Determining the noninfectious complications of indwelling urethral catheters: a systematic review and meta-analysis. Ann Intern Med. 2013 Sep 17;159(6):401-10. doi: 10.7326/0003-4819-159-6-201309170-00006.
PubMed 24042368O'Leary MP. Tamsulosin: current clinical experience. Urology. 2001 Dec;58(6 Suppl 1):42-8; discussion 48. doi: 10.1016/s0090-4295(01)01346-2.
PubMed 11750250Madani AH, Aval HB, Mokhtari G, Nasseh H, Esmaeili S, Shakiba M, Shakiba RS, Seyed Damavand SM. Effectiveness of tamsulosin in prevention of post-operative urinary retention: a randomized double-blind placebo-controlled study. Int Braz J Urol. 2014 Jan-Feb;40(1):30-6. doi: 10.1590/S1677-5538.IBJU.2014.01.05.
PubMed 24642148Narayan P, Tewari A. A second phase III multicenter placebo controlled study of 2 dosages of modified release tamsulosin in patients with symptoms of benign prostatic hyperplasia. United States 93-01 Study Group. J Urol. 1998 Nov;160(5):1701-6.
PubMed 9783935Lepor H. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Urology. 1998 Jun;51(6):892-900. doi: 10.1016/s0090-4295(98)00126-5.
PubMed 9609623Pummangura N, Kochakarn W. Efficacy of tamsulosin in the treatment of lower urinary tract symptoms (LUTS) in women. Asian J Surg. 2007 Apr;30(2):131-7. doi: 10.1016/S1015-9584(09)60146-9.
PubMed 17475584Yaycioglu O, Altan-Yaycioglu R. Intraoperative floppy iris syndrome: facts for the urologist. Urology. 2010 Aug;76(2):272-6. doi: 10.1016/j.urology.2010.01.025. Epub 2010 Mar 28.
PubMed 20350754Chang DF, Osher RH, Wang L, Koch DD. Prospective multicenter evaluation of cataract surgery in patients taking tamsulosin (Flomax). Ophthalmology. 2007 May;114(5):957-64. doi: 10.1016/j.ophtha.2007.01.011.
PubMed 17467530
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Tamsulosin for the Prevention of Post-operative Urinary Retention: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02486653
- Acronym / sponsor ID
- POUR / 2014-1494
- Conditions
- Urinary Retention, Urinary Tract Infections
- Keywords
- tamsulosin, randomized controlled trials as topic, double-blind method, random allocation, placebos, Adrenergic alpha-Antagonists, urinary retention, urinary tract infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Posted 23 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if tamsulosin ("FLOMAX") is effective in preventing post-operative urinary retention following abdominal surgery. Post-operative urinary retention is a common post-operative complication, occurring in up to 30% of patients undergoing abdominal surgery. It can be described as the inability to initiate urination or properly empty one's bladder following surgery. It is usually self-limited, but it requires the use of catheterization to empty the bladder in order to prevent further injury to the bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a medication that is commonly used in men with urinary symptoms related to an enlarged prostate. There is some evidence to suggest that it may also potentially be beneficial for preventing post-operative urinary retention. Therefore, in this research study, subjects scheduled for abdominal surgery will be randomly assigned to take either tamsulosin once-daily or placebo once-daily for one week leading up to surgery, and up to several days after surgery. Urinary function will be assessed and compared between these two treatments. The hypothesis is that tamsulosin will reduce the rate of postoperative urinary retention compared to placebo.
Detailed description
Postoperative urinary retention (POUR) complicates up to 30% of general abdominal operations. It results in patient discomfort, embarrassment, interference with therapies, and significant nursing burden. More importantly, urinary retention necessitates use of intermittent catheterization or placement of an indwelling urinary catheter, which exposes the patient to an increased risk of urinary tract infection (UTI), urethral injury, and potentially increased hospital length of stay and cost. For these reasons, a safe and effective intervention for preventing POUR would be highly valuable. Despite such a need, no contemporary studies exist evaluating medications that can be used to prevent POUR in broad general surgery populations. To address this gap, the investigators have designed a prospective, randomized, double-blind, placebo-controlled trial to test the hypothesis that preoperative loading with tamsulosin will prevent POUR in patients undergoing elective, inpatient complex intra-abdominal surgery and thereby lead to improved short-term outcomes.
Tamsulosin is a safe and widely-used selective alpha-1-A adrenergic blocker commonly used for the treatment of lower urinary tract symptoms in men with benign prostatic hypertrophy. It has also been shown to have some benefit in reducing POUR and need for catheterization in men undergoing inguinal hernia repair and other outpatient urologic procedures. This study is a randomized, double-blind, placebo-controlled trial in which patients scheduled for inpatient complex intra-abdominal surgery will be randomized to receive either tamsulosin or placebo for 7 days pre-operatively, and up to several days post-operatively, and then rates of POUR will be compared between the two groups (Aim 1). A retrospective analysis of the data will be used to identify risk factors for POUR and subgroups of patients that would derive the greatest benefit from preoperative tamsulosin (Aim 2). Furthermore, short-term outcomes, including rate of urinary tract infection (UTI) and hospital length of stay, will be compared between the tamsulosin and placebo groups (Aim 3).
Enrolled subjects will be randomized using a blocked, stratified randomization process to either tamsulosin or placebo. Stratification variables include gender, pelvic vs non-pelvic surgery, and International Prostate Symptom Score (IPSS) survey results (which is a measure of baseline lower urinary tract symptoms). After a 7-day treatment period, subjects will undergo surgery as scheduled, and then the assigned treatment will be continued for up to a total of 14 days until the subject either has return of normal voiding function, has required replacement of an indwelling urinary catheter, or is discharged from the hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Experimental | Drug: Tamsulosin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Able to provide informed consent
- Scheduled to undergo an elective, complex intra-abdominal operation with a planned postoperative inpatient stay of at least 1 night
Key exclusion criteria (15 listed)
- Less than age 18
- Allergy or contraindication to tamsulosin
- Serious sulfa allergy
- Current use of alpha blocker (alfuzosin, doxazosin, prazosin, silodosin, terazosin, verapamil, tamsulosin) or oral alpha agonist (midodrine), or initiation of one of these medications during the intervention phase of the study will result in subject withdrawal from the study
- Current warfarin use
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 |
|---|---|---|
| TamsulosinAlso: FlomaxTamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: tamsulosin 0.4mg in the evening * Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual <200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function. | Drug | Tamsulosin |
| PlaceboPlacebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: placebo in the evening * Day 8: surgery; placebo in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: placebo in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual <200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function. | Drug | Placebo |
Primary outcome
Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome
Time frame: within 0-7 days after surgery
need for any intermittent catheterization after leaving the operating room or after initial indwelling urinary catheter (IUC) removal; subjects will be straight catheterized if the subject either 1) reports bladder discomfort, or 2) has a bladder scan for >500milliliters; or 3) has a post-void residual volume >500milliliters
8 secondary outcomes
Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome
Time frame: within 0-7 days after surgery
Time Until First Spontaneous Void
Time frame: within 0-7 days after surgery
Total Number of Intermittent Catheterizations Required Per Subject
Time frame: within 0-7 days after surgery
First Post-void Residual Urine Volume
Time frame: within 0-7 days after surgery
Discharge From Hospital With Indwelling Urinary Catheter
Time frame: up to 30 days after surgery
Urinary Tract Infection (UTI)
Time frame: up to 30 days after surgery
Hospital Length of Stay in Days
Time frame: up to 30 days after surgery
Number of Participants Who Experienced Adverse Events
Time frame: treatment day 1 (7 days before surgery) until 30 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20927768Buckley BS, Lapitan MC. Drugs for treatment of urinary retention after surgery in adults. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD008023. doi: 10.1002/14651858.CD008023.pub2.
- Background: PubMed 23492981Choi S, Awad I. Maintaining micturition in the perioperative period: strategies to avoid urinary retention. Curr Opin Anaesthesiol. 2013 Jun;26(3):361-7. doi: 10.1097/ACO.0b013e32835fc8ba.
- Background: PubMed 24709715Lo E, Nicolle LE, Coffin SE, Gould C, Maragakis LL, Meddings J, Pegues DA, Pettis AM, Saint S, Yokoe DS. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 May;35(5):464-79. doi: 10.1086/675718. No abstract available.
- Background: PubMed 24042368Hollingsworth JM, Rogers MA, Krein SL, Hickner A, Kuhn L, Cheng A, Chang R, Saint S. Determining the noninfectious complications of indwelling urethral catheters: a systematic review and meta-analysis. Ann Intern Med. 2013 Sep 17;159(6):401-10. doi: 10.7326/0003-4819-159-6-201309170-00006.
- Background: PubMed 11750250O'Leary MP. Tamsulosin: current clinical experience. Urology. 2001 Dec;58(6 Suppl 1):42-8; discussion 48. doi: 10.1016/s0090-4295(01)01346-2.
- Background: PubMed 24642148Madani AH, Aval HB, Mokhtari G, Nasseh H, Esmaeili S, Shakiba M, Shakiba RS, Seyed Damavand SM. Effectiveness of tamsulosin in prevention of post-operative urinary retention: a randomized double-blind placebo-controlled study. Int Braz J Urol. 2014 Jan-Feb;40(1):30-6. doi: 10.1590/S1677-5538.IBJU.2014.01.05.
- Background: PubMed 9783935Narayan P, Tewari A. A second phase III multicenter placebo controlled study of 2 dosages of modified release tamsulosin in patients with symptoms of benign prostatic hyperplasia. United States 93-01 Study Group. J Urol. 1998 Nov;160(5):1701-6.
- Background: PubMed 9609623Lepor H. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Urology. 1998 Jun;51(6):892-900. doi: 10.1016/s0090-4295(98)00126-5.
- Background: PubMed 17475584Pummangura N, Kochakarn W. Efficacy of tamsulosin in the treatment of lower urinary tract symptoms (LUTS) in women. Asian J Surg. 2007 Apr;30(2):131-7. doi: 10.1016/S1015-9584(09)60146-9.
- Background: PubMed 20350754Yaycioglu O, Altan-Yaycioglu R. Intraoperative floppy iris syndrome: facts for the urologist. Urology. 2010 Aug;76(2):272-6. doi: 10.1016/j.urology.2010.01.025. Epub 2010 Mar 28.
- Background: PubMed 17467530Chang DF, Osher RH, Wang L, Koch DD. Prospective multicenter evaluation of cataract surgery in patients taking tamsulosin (Flomax). Ophthalmology. 2007 May;114(5):957-64. doi: 10.1016/j.ophtha.2007.01.011.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Evie H Carchman, MD principal investigator
University of Wisconsin - Madison School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamsulosin in people with Urinary Retention and Urinary Tract Infections, run by University of Wisconsin, Madison 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 3 inclusion and 15 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: finished, as of the sponsor's last update on 25 Sep 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome (time frame: within 0-7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02486653, which also lists 11 linked publications.
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 25 Sep 2019.