Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention
Phase: NA
Conditions: Post-Operative Urinary Retention
Sponsor: University of Rochester

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Department of Urology 
 
 
Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention 
 
 
Principal Investigator: 
Edward M. Messing, MD (Urology) 
 
Sub-Investigators: 
Benjamin Nelson, MD (Urology) 
 
Janet Kukreja, MD, MPH (Urology) 
 
Scott Quarrier, MD (Urology) 
 
Joseph Johnson, MD (General Surgery, Highland Hospital) 
 
Rabih Salloum, MD (General Surgery) 
 
Carolyn Jones, MD (Thoracic Surgery) 
 
Wendy Hurley, PA-D, MS (Thoracic Surgery) 
 
 
1. PURPOSE OF THE STUDY AND BACKGROUND 
 
1.1. Purpose of the study 
 
Primary Aim 
• The primary outcome of this study is to assess how the prophylactic 
administration of tamsulosin affects the rate of post-operative urinary retention 
(POUR) for a select group of surgical procedures 
 
Secondary Aims 
• The secondary outcomes include: 
o Assess the relationship between I-PSS score and likelihood of POUR in 
treatment and control groups 
o Assess post-operative post-void residual volumes between groups 
 
 
1.2. Background 
 
Post-operative urinary retention (POUR) remains one of the most common 
surgical complications encountered.  Rates of POUR remain variable in the 
current literature with rates between 3% 1 and 41%2 (Peterson, et al) reported. 

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Tamsulosin is a common medication used in patients with urinary retention and 
lower urinary tract symptoms.  It works by blocking alpha receptors in the 
prostate and bladder neck allowing for improved outflow of urine.  Fortunately 
tamsulosin is quite safe, is well-tolerated by patients, and has few side effects.  
The use of tamsulosin for POUR is currently not given until urinary retention is 
diagnosed.  However there is emerging evidence that tamsulosin may have 
prophylactic properties against POUR.  In one placebo-controlled trial, 
prophylactically administered tamsulosin was shown to significantly reduce the 
rates of urinary retention after inguinal herniorrhaphy from 15% to 25% when 
administered 6 hours prior to surgery3.  Interestingly, with a half-life of 
approximately 14 hours, tamsulosin would not achieve steady state concentrations 
within such a short time frame.  Similarly, Madani, et al showed a reduction in 
POUR rates from 21.1% to 5.9% when tamsulosin was administered 14 and 2 
hours prior to inguinal or scrotal surgery.4   POUR is often multifactorial in nature.  
However, there are known risk factors for urinary retention including age, gender, 
and previous episodes of urinary retention. 
 
 
2. STUDY DESIGN 
 
2.1. Overview 
 
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.  
 
2.2. Rationale for Study Design 
 
Granted that a placebo-controlled trial would be a more powerful study, the complex 
issues of acquiring and distributing a placebo for a generic medication have led to the 
above described non-placebo controlled design.  
 
2.3. Rationale for Dosage 
 
Standard dosing for tamsulosin is 0.4mg administered orally.  Tamsulosin is typically 
administered once daily in the evening as recommended by the manufacturer.  Three 
doses was the prescribed pre-surgical treatment regimen based on the known half-life 
of tamsulosin being 14 hours.   As such, 3 doses will allow for >5 half-lives of the 
medication at therapeutic dosing to achieve a therapeutic steady state.  Tamsulosin has 
been proven to be well tolerated by elderly populations. 
 
 
 

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3. CHARACTERISTICS OF THE RESEARCH POPULATION 
 
3.1. Subject Characteristics 
 
a) Number of Subjects: 
A total of 160 subjects will be enrolled in this study (80 within the control group 
(no tamsulosin) and 80 within the treatment group (receive tamsulosin). 
 
b) Gender and Age of Subjects: 
Only males age 40 years and older will be included in this study.  Males alone will 
be selected due to the fact that tamsulosin and its role in urinary retention have been 
best proven and most reliably useful in males.  This age was selected because older 
males are considered at highest risk of POUR. 
 
c) Racial and Ethnic Origin: 
There will be no racial or ethnic restrictions for participation. 
 
d) Vulnerable Subjects:  
There will be no vulnerable subjects included in this study. 
 
 
3.2. Inclusion and Exclusion Criteria 
 
a) 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 
• Willing to participate in the study 
• Any racial or ethnic origin 
 
b) 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 
 

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3.3. Discussion of Subject Population 
Patients with upcoming cataract surgery will be excluded due to the known floppy iris 
syndrome associated with tamsulosin administration.  Those with a severe reaction to 
sulfa drugs will be excluded due to a known, but relatively uncommon cross-sensitivity 
between tamsulosin and sulfa drugs.  
 
 
4. SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT 
 
4.1. Method of Subject Identification And Recruitment 
 
Patients of the investigators listed in this protocol (thoracic, surgery, urology), who 
have been identified as appropriate for the above listed procedures and who meet 
inclusion/exclusion criteria, will be offered the option to enroll in this study.  This will 
occur at the time of in-office surgical consultation for the proposed procedure.  Subjects 
will be recruited from and surgeries will be performed at both SMH and HH.  This 
study will receive Highland Hospital approval prior to enrolling subjects. 
 
4.2. Process of Consent 
The care provider who will see the patient for the in-office surgical consultation will 
offer participation if the patient meets inclusion/exclusion criteria.  Eligible subjects 
will be allowed to take a copy of the consent form home for review.  The care provider 
will ask the patient if they would like to be contacted about the study from a research 
team member.  If the patient agrees to be contacted, the care provider will forward the 
patient’s contact information to the team member.  The team member will contact the 
patient to check interest in participation and answer any questions.  If they choose to 
enroll in the study, a visit will be scheduled and consent will be obtained by a member 
of the research team.  Study objectives, procedures, potential risks, benefits and 
alternatives (such as not to participate) will be discussed.  Patients will be reminded 
that they can elect not to participate without risking loss of present care they would 
otherwise expect to receive.  Research interventions vs standard of care interventions 
will be clearly stated to the patient during the consenting process.  A copy of the signed 
consent form will be given to the subject and the original consent form will be placed in 
the research record.  Consent will be obtained in a private place with a closed door to 
ensure privacy. 
 
 
 

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5. METHODS AND STUDY PROCEDURES 
 
Eligible subjects who agree to participate will be randomized to one of the following 
two groups: 
 
1. Control Group 
Subjects in the control group will undergo the planned general, urologic, or thoracic 
surgery procedure and receive no tamsulosin, but will receive education about the 
signs and symptoms of urinary retention. 
 
2. Treatment Group – patients who are to undergo the following surgeries will be 
included in this group: 
 
• Open inguinal herniorrhaphy 
• Inguinal orchiectomy 
• Transscrotal hydrocelectomy 
• Transscrotal spermatocelectomy 
• Laparoscopic cholecystectomy 
• Laparoscopic Nissen fundoplication 
• Laparoscopic paraesophageal hernia repair 
• Thoracoscopy 
 
Subjects will receive education about the signs and symptoms of urinary retention 
 
Once identified by participating surgeons as potentially eligible to participate in the 
study, patients will be directed to a study team member who will review and 
confirm study eligibility, obtain consent, medical history, demographic information, 
concomitant medications, randomization, and distribution of medication (if 
applicable). 
 
Control Group 
Subjects in the control group will receive education about the signs and symptoms 
of urinary retention. 
 
Treatment Group 
Subjects in the treatment group will be called 3 days prior to their scheduled 
procedure.  During this telephone encounter, subjects will be reminded to initiate 
the study medication (1 dose each night for 3 consecutive nights prior to surgery).  
Also, subjects will receive education on the signs and symptoms of urinary 
retention. 
 
All subjects will complete the International Prostate Symptom Score (I-PSS) 
voiding symptom score index (Appendix 2).  Subjects will be asked to complete 
this standard of care validated questionnaire prior to surgery (at the time consent is 
obtained) and during the post-op telephone contact (research procedure).  

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Completion of the I-PSS questionnaire will not be considered compulsory for 
inclusion as the score will be used for comparison of groups and not a measurement 
of primary outcome.  
 
All subjects will undergo post-void residual (PVR) bladder volume monitoring 
using an ultrasound bladder scanner prior to surgery to assess baseline voiding. 
Preoperative bladder scanning will be considered an investigational procedure done 
specifically for the purposes of the study.  At this time, subjects randomized to take 
tamsulosin will be interviewed regarding any adverse effects noted since initiating 
the study medication.  Responses will be documented on a study-specific form, 
along with PVR results.  This form will be incorporated into the subject’s study file.  
Subjects will then undergo routine perioperative cares per indicated procedure.  
Following surgery, subjects will be monitored for ability to void.  Subjects who 
undergo procedures that typically involve bladder catheterization will have urinary 
catheters removed at 12 hours post procedure.  Subjects undergoing same-day 
surgeries will be required to void prior to discharge with measurement of a PVR.  
Routine PVR measurement before surgery and after surgery if a patient is able to 
void is not considered standard of care in the absence of urinary retention symptoms 
and will be a considered a non-invasive research procedure.  PVR measurement at 
the included institutions is not a billed procedure and will not produce any expense 
for the participating subjects.  
 
Urinary retention will be defined as discomfort with the sensation of a full bladder 
and a bladder volume >500ml by ultrasonic bladder scan or straight catheterization 
for discomfort secondary to bladder distention. 
 
All subjects in the treatment group will continue tamsulosin for 2 doses after a 
successful void.  A study team member will call the subject within a week of their 
surgery to assess for any adverse reactions and to check compliance with the study 
drug. 
 
Subjects with failure to void will have straight catheterization performed once and a 
trial of voiding will be reinitiated.  A second failure to void will prompt the 
insertion of an indwelling Foley catheterization for a period of 3-5 days prior to an 
attempt to void.  Both of these procedures are considered standard of care practices. 
A prescription for tamsulosin will be given to both treatment and control groups for 
28 additional days for failure to void (a standard of care practice). 
 
Patients who require outpatient follow-up will have an appointment made with the 
on-call urologist or urologist’s midlevel provider for that day per the standard 
practices of our institution.  Continuation of tamsulosin will be at the discretion of 
the urologist with whom the patient follows up. 
 

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A Schedule of Activities can be found in Appendix 1.  
 
 
5.1. Treatment Dosage and Administration 
 
Those subjects randomized into a treatment arm undergoing planned outpatient 
procedures will receive 0.4mg tamsulosin by mouth nightly for 3 doses prior to the 
day of surgery and for 2 doses following surgery, medication education, and 
education about signs and symptoms of urinary retention.  Subjects will be given a 
package of 5 tablets of tamsulosin prior to their surgery at the time of consent and 
randomization.  The package will be appropriately labeled to include the research 
study name, study medication name, instructions on how/when to take the study 
medication, and study team contact information.  Study medication will be provided 
via the UR Pharmacy.  It will be ordered, purchased and distributed by the 
Department of Urology at no cost to the subject.  Compliance with medication usage 
will be assessed via verbal confirmation the morning of the scheduled surgery and at 
the post-op telephone contact.  This will be documented by the study team member 
and included in written form within the subject’s file.  Study medication will be 
stored in a locked cabinet and only accessed by the study team to be distributed to 
those subjects randomized to treatment groups at the time informed consent is 
obtained. 
 
Subjects undergoing planned inpatient procedures will bring their remaining 2 doses 
to the hospital with them.  Per hospital policies regarding home medications, the 
tablets will be sent to the inpatient pharmacy for verification and distributed to the 
patient by the nursing staff of the unit to which they are admitted. An order will be 
placed by the admitting team for Tamsulosin 0.4mg to be taken nightly.  Should a 
subject be unexpectedly admitted following a same-day, outpatient procedure, it will 
be requested that the subject’s arranged ride (as patients are not allowed to drive 
themselves home after procedures) bring the remaining tablets to the patient.  Should 
no individual be available to deliver the tablets to the subject, Benjamin Nelson, MD 
(sub-investigator) will be contacted, and 2 tablets will be supplied from the study 
supply of medication and delivered to the subject’s unit.  
 
 
 
5.2. Efficacy Assessments 
 
The I-PSS prostate symptom score index will be used to assess preoperative prostatism 
symptoms.  This is an internationally recognized questionnaire for the assessment of 
prostate-related voiding complaints (Appendix 2). 
 
Pre and post-operative bladder volumes will be assessed using an ultrasound bladder 
scanner.  This will be accomplished by the perioperative nursing staff.  This is a 
standard of care measurement devised for assessing bladder volumes.  The use of such 

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a machine is part of basic nursing care training.  Documentation of each bladder scan 
assessment will be incorporated into the subject’s research profile.  Urinary retention 
will be defined as discomfort with the sensation of a full bladder and a bladder volume 
>500ml by ultrasonic bladder scan or straight catheterization for discomfort secondary 
to bladder distention. 
 
Compliance with medication usage will be assessed via verbal confirmation the 
morning of the scheduled surgery at the post-op telephone encounter.  This will be 
documented by the study team member and included in written form within the 
subject’s file.   
 
 
5.3. Safety Assessments 
 
Medical history and basic physical exam will be performed as part of the standard 
preoperative work-up.  Medication lists will be confirmed at each encounter per 
hospital policies.  Bladder volumes will be assessed using a standard ultrasound bladder 
scanner.  Use of this machine is standard nursing practice and imparts no added risk to 
the subjects.  Failure to void will be managed per standard post-operative policies with 
a trial of sterile straight catheterization for the first episode of urinary retention.  Any 
subsequent inability to void will be managed with a sterilely placed indwelling Foley 
catheter for a period of 3-5 days prior to an attempt to void.  Both of these procedures 
are considered standard of care practices.  A prescription for tamsulosin to be filled 
with the subject’s discharge prescriptions will be given to both treatment and control 
groups for 28 days for failure to void (a standard of care practice). 
 
5.4. Assessment of Subject Compliance 
Confirmation of study medication adherence will be verbally assessed by a study team 
member and documented in the subject’s research record.  
 
5.5. Costs to the Subject 
There are no costs to the subject for their participation in this study.  The Department of 
Urology will provide study medication to subjects assigned to the treatment arm.   
 
5.6. Payment for Participation 
Subjects will not receive financial reimbursement for participation in this study.  A 
parking pass will be given at the first visit. 
 
 
5.7. Return of Individual Research Results 
Subjects will be informed of bladder volumes at the time of bladder scanning.  All other 
research results will be evident to the subjects based on the nature of the study as they 
will be aware of the presence or absence of urinary retention.  

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6. CONCOMITANT AND DISALLOWED MEDICATIONS 
 
Concomitant use of other alpha-blockers will be disallowed and part of the exclusion criteria 
for this study.  Those subjects who take medications considered strong CYP 3A4 inhibitors 
will also be excluded.  
 
 
7. SUBJECT WITHDRAWALS 
 
Subjects will be withdrawn from the study if they: 
• Experience an adverse reaction to the study medication 
• Elect to withdraw from the study voluntarily 
 
Subjects who have been withdrawn from the study will not be replaced as a predicted 10% 
drop-out rate has been included in the sample size calculations.  
 
 
8. STUDY DRUG / DEVICE / BIOLOGIC ADMINISTRATION / 
ASSIGNMENT 
 
8.1. Study Drug/Device/Biologic 
• Tamsulosin 
 
8.2. Dosage of Study Drug/Biologic 
• Tamsulosin 0.4mg oral tablet every night x 5 (3 days prior to surgery and 2 days 
following surgery) 
 
8.3. Subject Enrollment/Randomization 
Subjects will be randomized to a treatment or control group using a computerized 
randomization tool based on the order in which subjects are enrolled.  
 
8.4. Accountability of Investigational Supplies 
Study medication will be stored in a locked cabinet and only accessed by the study 
team.  Study medication will be distributed to the subjects directly by the study team. 
Any returned medication will be documented within the study subject’s research record 
and disposed of according to the research pharmacy recommendations.  
 
8.5. Subject Withdrawal of Study Drug 
Subjects who withdraw from the study will not be eligible to continue to be followed in 
the study. 

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8.6. Emergency Drug Disclosure 
As this is not a blinded study, emergency drug disclosure does not apply. 
 
 
9. SAFETY AND REPORTABLE EVENTS 
 
9.1. Adverse Event Definition 
An adverse event is any symptom, sign, illness, or experience which develops or 
worsens during the course of the study, whether or not the event is considered related to 
the study intervention/drug. 
 
9.2. Serious Adverse Event Definition 
A serious adverse event is defined as any adverse medical experience that results in any 
of the following outcomes: 
• death 
• is life-threatening; 
• requires inpatient hospitalization or prolongation of existing hospitalization; 
• results in persistent or significant disability/incapacity; 
• is a congenital anomaly/birth defect; or 
• requires medical or surgical intervention to prevent permanent impairment or 
damage 
 
 
9.3. Recording Adverse Events 
An adverse event log will be maintained for the duration of the study.  The study team 
will assess adverse events by observation by the investigator, clinical findings, and all 
voluntary complaints of the subject and will be recorded in the subject’s research 
record. 
 
In the case of an adverse event, the subject will be monitored and managed at the time 
of the event by the study team and documented in the subject chart.  Each adverse event 
will include a brief description of the experience, the date of onset, date of resolution, 
duration and type of experience, the severity, the relationship to the investigational 
agent, contributing factors, and any action taken. 
 
Adverse events will be documented from the time of subject consent until their 
completion or withdrawal from the study.  Follow-up of adverse events will include 
those that are ongoing/unresolved at the time of subject concluding study participation. 
 
 
 

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9.4. Responsibilities for Reporting Serious Adverse Events 
All serious adverse events will be documented on the Adverse Event Log and subject’s 
research chart from the time of signing the consent form to the final study visit or post-
op telephone contact.  The principal investigator will be notified immediately of any 
serious adverse events, and subsequently, the RSRB while complying with regulations 
and RSRB policy regarding the reporting of adverse events. 
 
10.  RISK/BENEFIT ASSESSMENT 
 
10.1. Potential Risks 
Known adverse effects of tamsulosin administration include:  orthostatic hypotension 
(0.2%-0.4%), dizziness (up to 15%), headache (up to 19% and similar rate to placebo), 
ejaculation failure (8-18%), floppy iris syndrome, and very rarely priapism (1 in 
50,000)5.  Allergic-type reactions such as skin rash, urticaria, pruritus, angioedema and 
respiratory symptoms have been reported in fewer than 1% of those taking tamsulosin. 
 
10.2. Protection Against Risks 
To protect subjects from risk, all individuals with a previous adverse reaction to 
tamsulosin will be excluded from participation in this study.  Those who may undergo 
future cataract surgery will also be excluded due to the risk of floppy iris syndrome.  
Individuals with a known severe reaction (anaphylaxis) to sulfonamides will be 
excluded due to known cross-sensitivities.  Those taking medications defined by the 
FDA as strong CYP 3A4 inhibitors will also be excluded.  
 
10.3. Potential Benefits to Subjects 
 
Subjects may benefit due to the potential prevention of POUR and its attendant results 
including pain/discomfort, infection, and need for prolonged catheterization. 
 
10.4  Alternatives to Participation 
There are no alternatives to participation.  This study is voluntary and subjects do not 
have to participate. 
 
 
11.  CONFIDENTIALITY OF DATA AND INFORMATION STORAGE  
 
All subjects will be assigned a unique study number and the key will be kept on a 
password-protected database in a locked office of the study team.  Subject data will be 
restricted to individuals named in this application.  All source documents and other printed 
PHI will be stored and maintained in the locked offices of the study team.   
 
 

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12.  RESEARCH INFORMATION IN MEDICAL RECORDS 
 
Bladder scan volumes will be recorded in the subject’s medical record.  Administration of 
study medication will be documented in the medical record. 
 
 
13.  DATA ANALYSIS AND MONITORING 
 
13.1. Sample Size Determination 
Given the urinary retention rate in a baseline of expected urinary retention of between 
15% and 21% in the specified procedures3,4 , previous studies with tamsulosin have 
decreased rates of POUR from between 2.5% and 5.9%.3,4  To detect a 15% difference 
between the groups, with an alpha of 0.05 and beta of 80%, a total of 142 patients is 
required; 72 within the control group (no tamsulosin) and 72 within the  treatment 
group (receive tamsulosin.)  To account for patient drop-out rate of approximately 10%, 
a total of 160 subjects will be enrolled (80 subjects in each group.) 
 
13.2. Planned Statistical Analysis 
The primary endpoint of straight catheterization incidence will be analyzed with chi-
squared.  Postoperative PVR will be computed as a continuous variable using a t-test 
between the control and each treatment group.  Data recorded will be I-PSS scores if 
returned.  Incidence of urinary retention, all bladder scan volumes, return to any health 
care facility for urinary retention, how long urinary retention persisted.  Incidence of 
any drug adverse side effects will also be recorded. 
 
13.3. Data and Safety Monitoring 
Because tamsulosin is quite safe, is well-tolerated by patients, and has few side effects, 
oversight and monitoring of the conduct and progress of the study will occur every 4 
months with the Principal Investigator and members of the study team.  The Principal 
Investigator will be notified immediately for all serious adverse events.  Adverse events 
that are not serious will be managed by the study team (in the departments of Urology, 
Thoracic, and General Surgery) and reported to the Principal Investigator every 4 
months, unless otherwise deemed necessary, such as information that may affect the 
safety or welfare of subjects, as well as the validity and integrity of the data. 
 
 
 

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14.  REFERENCES 
 
1. Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: anesthetic 
and perioperative considerations. Anesthesiology. 2009; 110: 1139-57 
 
2. Petersen MS, Collins DN, Selakovich WG, Finkbeiner  AE. Postoperative urinary 
retention associated with total hip and total knee arthroplasties. Clin Orthop Relat Res 
1991; 269: 102-8 
 
3. Mohammadi-Fallah M, Hamedanchi S; Tayyebi-Azar A. Preventive effect of 
tamsulosin on postoperative urinary retention. Korean J Urol 2012; 53: 419-423 
 
4. Madani AH,  et al. Effectiveness of tamsulosin in prevention of post-operative urinary 
retention: a randomized double-blind placebo-controlled study. Br J Urol Int 2014; 40: 
30-6 
 
5. Lexi-Comp, Inc. (Lexi-Drugs). Lexi-Comp, Inc.; Accesed: March 22, 2015. 
 
 
 

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APPENDIX 1 
 
 
Schedule of Activities for Control Group 
 
PROCEDURES 
Research 
Visit 
 Day of 
Surgery 
 Post-op  
Phone Call 
Confirm Eligibility 
X 
 
 
Obtain Informed Consent 
X 
 
 
Randomization 
X 
 
 
Medical History and Demographics 
X 
 
 
Concomitant Medication Review 
X 
 
 
Education of Urinary Retention 
X 
 
 
I-PSS Questionnaire 
X 
 
X 
Ultrasound Bladder Scan (pre- and 
post-op) 
 
X 
 
 
 
 
Schedule of Activities for Treatment Group 
 
 
 
 
 
 
PROCEDURES 
Research 
Visit 
3 Days 
Prior to 
Surgery 
 Day of 
Surgery 
 Post-op  
Phone Call 
Confirm Eligibility 
X 
 
 
 
Obtain Informed Consent 
X 
 
 
 
Randomization 
X 
 
 
 
Medical History and Demographics 
X 
 
 
 
Concomitant Medication Review 
X 
 
X 
 
Education of Urinary Retention 
X 
 
 
 
I-PSS Questionnaire 
X 
 
 
X 
Dispense Study Drug  
X 
 
 
 
Study Drug Compliance 
 
 
X 
X 
Phone Call (study drug reminder) 
 
X 
 
 
Adverse Event Review 
 
 
X 
X 
Ultrasound Bladder Scan (pre- and 
post-op) 
 
 
X 
 

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APPENDIX 2 
 
 
 
See (PDF) I-PSS Questionnaire