Clinical trial NCT04682366
Conditions: Urinary Retention
Keywords: Postoperative care Urinary tract infection Female pelvic reconstructive surgery Enhanced recovery after surgery Tamsulosin Flomax
Sponsor: Wake Forest University Health Sciences
Start date: 2021-10-19; Completion date: 2022-11-10
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blinded randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery undergoing same-day discharge with an enhanced recovery after surgery protocol.

Detailed description:
The primary objective is to determine the effect of Tamsulosin on same-day active voiding trial in women undergoing female pelvic reconstructive surgery with vaginal native tissue repair with same-day discharge planned.

Duration of catheterization, postoperative urinary tract infection rates, patient level of satisfaction, Emergency Department (ED) visits and adverse events postoperatively will also be compared between women receiving Tamsulosin versus placebo.

Patients will be offered participation in the study at their postoperative visit if they meet study criteria. Once consent is obtained, patients will be randomized to receive Tamsulosin 0.4 mg orally once daily or matching placebo capsules for a total of 10 days starting 5 days pre-operatively.

Arms: arm 1: Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed. arm 2: Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.
Interventions: intervention 1: Tamsulosin intervention 2: Placebo
Intervention descriptions: intervention 1: Oral drug: 10 days of 0.4 mg of oral Tamsulosin intervention 2: Oral drug: 10 days of identical-appearing placebo

Protocol documents:
ICF_000.pdf: 
NCT04682366
Official Title: Evaluating the Effect of Tamsulosin on Postoperative Urinary 
Retention in Women Undergoing Same Day Hospital Discharge Following 
Pelvic Reconstructive Surgery: A Randomized Trial  
IRB-Approved Date:  4/12/22


1
Evaluating the effect of Tamsulosin on Postoperative Urinary 
Retention in Women undergoing Same Day Hospital Discharge 
Following Pelvic Reconstructive Surgery: A Randomized Trial
PI: Majid Mirzazadeh MD
Informed Consent Form to Participate in Research
SUMMARY
You are invited to participate in a research study. The purpose of this research 
is to help determine if starting tamsulosin (commercially known as Flomax) 5 
days prior to surgery will help decrease your chances of going home with a 
bladder catheter the same day of your surgery, and continuation for 5 more 
days after surgery to avoid retention of urine in near future. You are invited 
to be in this study because you have decided to undergo a vaginal approach 
for treating your pelvic organ prolapse. Your participation in this research will 
involve your first 2 postoperative visits and will last 6 weeks. 
Participation in this study will involve you receiving 0.4 mg (standard dose) of 
tamsulosin or a placebo pill once a day for 10 days (4 days before the surgery, 
1 pill on the day of surgery before the procedure, and 5 pills after surgery). 
You will take the pill at the same time, early morning between 07:00 and 
09:00). The placebo pill is an inactive substance (usually sugar) prepared to 
look as similar to the active product investigated in a study as possible. You 
will be chosen to receive either type of pill at random based on a computer-
generated algorithm. You may know which pill you have received when your 
individual study has concluded which will be at your 6-week visit. Tamsulosin 
medication is FDA approved, however use in women is not approved by the 
FDA. 
Your participation in this study is voluntary. You do not have to participate in 
this study if you do not want to. There may be other choices available to you. 
Your other choice is to not receive either the tamsulosin or the placebo and 
still undergo your proposed surgical plan. You will not lose any services, 
benefits, or rights you would normally have if you choose not to participate.
The remainder of this form contains a more complete description of this study. 
Please read this description carefully. You can ask any questions if you need 
help deciding whether to join the study. The person in charge of this study is 
Majid Mirzazadeh, MD, the principle investigator of this study and Amr El 
Haraki, MD, co-investigator. If you have questions, suggestions, or concerns 
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regarding this study or you want to withdraw from the study their contact 
information is:
If you have any questions, suggestions or concerns about your rights as a 
volunteer in this research, contact the Institutional Review Board at 
 or the Research Subject Advocate at Wake Forest at 
.
INTRODUCTION
You are invited to be in a research study. Research studies are designed to 
gain scientific knowledge that may help other people in the future. You are 
being asked to take part in this study because you have pelvic organ prolapse 
and will be undergoing vaginal corrective surgery for this. Your participation 
is voluntary. Please take your time in making your decision as to whether or 
not you wish to participate. Ask your study doctor or the study staff to explain 
any words or information contained in this informed consent document that 
you do not understand. You may also discuss the study with your friends and 
family.
WHY IS THIS STUDY BEING DONE?
The purpose of this research study is to help determine if preoperative 
tamsulosin will decrease your chances of going home with a bladder catheter 
on the same day of your surgery, and potentially thereafter. We will also 
assess whether or not you have a postoperative urinary tract infection, urinary 
retention as well as your overall improvement of urinary tract symptoms on a 
questionnaire and if you needed prolonged catheterization.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
88 people will take part in this study.
WHAT IS INVOLVED IN THE STUDY?
At your first visit, you will have a baseline post void residual (the amount of 
urine left in your bladder after you have emptied it in the restroom) measured 
by a bladder scanner (a portable ultrasound machine that will determine how 
much urine is left in your bladder); fill out a form to determine if you are 
eligible to participate in the study) and receive one medication bottle which 
will contain either the tamsulosin or placebo. You will be instructed to start 
taking the pill 4 days prior to day of surgery, start filling out the provided form 
to indicate date and time of investigation medication taken.
After surgery, we will start an active voiding trial on the day of surgery. This 
involves filling your bladder up prior to removing the catheter and checking to 
see how well you empty your bladder. This is standard for all our patients 
whether or not they are part of the study.
At your first postoperative visit one week from surgery, we will measure your 
post void residual again, obtain a urinalysis to look for infection and have you 
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fill out a questionnaire. You will also return your medication bottle at this visit 
with the completed form indicating 10 days and time of dosage. We will review 
the form with you to verify the information. If you have a visit before one 
week, you will be requested to take the bottle back with you to complete 10 
days of dosing and return the bottle by next visit (6 week time).  
At your second postoperative visit six weeks from surgery, we will measure 
your post void residual again and obtain another urinalysis.  
You will be randomized into one of the study groups described below. 
Randomization means that you are put into a group by chance. It is like 
flipping a coin. You will have an equal chance of being placed in any group.
You will either fall in a group of study patients who receive tamsulosin or a 
group of study patients who receive placebo pills. You will not be informed the 
group you are in to avoid any effect on your selections of your postoperative 
questionnaire
HOW LONG WILL I BE IN THE STUDY?
You will be in the study for about 6 weeks.
You can stop participating at any time. If you decide to stop participating in 
the study we encourage you to talk to the investigators or study staff first to 
learn about any potential health or safety consequences. Currently, there are 
no serious consequences for withdrawing early from the study.
WHAT ARE THE RISKS OF THE STUDY?
This study trial may or may not benefit to you. Tamsulosin medication may 
potentially be helpful in increasing your chances at passing your voiding trial 
(Voiding trial is a trial to pass urine) after surgery; therefore, there is a risk 
that you may be assigned to a group that does not perform as well as its 
comparison. 
Of note, tamsulosin has not FDA-approved use in women. At the present time, 
we do not use alternatives to tamsulosin as this is a new indication for usage.
All research studies involve some risks. Risks of this study to be aware of 
comprise of the side-effects of tamsulosin which include, but are not limited 
to orthostatic hypotension which is a drop in blood pressure when standing 
or sitting up, dizziness, postoperative atrial fibrillation, abdominal pain, 
asthenia- ( weakness), constipation, dry mouth, headache, runny nose, 
diarrhea , fainting, nausea , insomnia – difficulty falling sleep, back pain, 
runny eyes , floppy iris syndrome (a rare condition that occurs during 
cataract surgery, which causes a poor pupillary dilation).Though rare, this 
drug 
can cause severe skin reactions, including a serious condition called 
Stevens-Johnson syndrome. 
These skin reactions can cause raised welts, facial swelling, fever, and 
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trouble breathing You may or may not receive benefit by participating in this 
study.
The risks associated with this study are the risks associated with the drug in 
addition to any inherent surgical risks for the surgery you will be receiving 
which do not change with this study. These risks are the same if you chose to 
participate in this study or not.
In addition, there is a slight risk of a breach of confidentiality. We will do our 
best to protect your confidential information. There also may be other side 
effects that we cannot predict. You should tell the research staff about all the 
medications, vitamins and supplements you take and any medical conditions 
you have. This may help avoid side effects, interactions and other risks. Taking 
part in this research study may involve providing information that you consider 
confidential or private. Efforts, such as coding research records, keeping 
research records secure and allowing only authorized people to have access 
to research records, will be made to keep your information safe.
Reproductive Risks and other Issues to Participating in Research
Due to unknown risks and potential harm to the unborn fetus, sexually active 
women of childbearing potential must use a reliable method of birth control 
while participating in this study. Reliable methods of birth control are: 
abstinence (not having sex), oral contraceptives, intrauterine device (IUD), 
Depo Provera, tubal ligation, or vasectomy of the partner (with confirmed 
negative sperm counts) in a monogamous relationship (same partner). An 
acceptable, although less reliable, method involves the careful use of condoms 
and spermicidal foam or gel and/or a cervical cap or sponge. We encourage 
you to discuss this issue further with your physicians if you have any 
questions. Pregnant women are excluded from participation in this study. 
Because some methods of birth control are not 100% reliable, a pregnancy 
test is required at least 10 days from your last normal menstrual period, if you 
are a sexually active woman of childbearing potential.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
You may or may not receive benefit from taking part in this research study. 
We hope the information learned from this study will benefit other people in 
the future.
WHAT OTHER CHOICES ARE THERE?
You do not have to be in this study to receive treatment. You should talk to 
your doctor about all the choices you have. Instead of being in this study, you 
have these options: To undergo your scheduled surgery without use of 
preoperative medication that can potentially increase your chances of 
succeeding your voiding trial. 
WHAT ARE THE COSTS?
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All study costs will be paid for by the study. Costs for your regular medical 
care, which are not related to this study will be your own responsibility. You 
will not be charged for the investigational medication (10 pills).
WILL YOUR RESEARCH RECORDS BE CONFIDENTIAL?
The results of this research study may be presented at scientific or medical 
meetings or published in scientific journals. Your identity and/or your personal 
health information will not be disclosed unless it is authorized by you, required 
by law, or necessary to protect the safety of yourself or others. There is always 
some risk that even de-identified information might be re-identified. 
Participant information may be provided to Federal and other regulatory 
agencies as required. The Food and Drug Administration (FDA), for example, 
may inspect research records and learn your identity if this study falls within 
its jurisdiction.
WILL YOU BE PAID FOR PARTICIPATING?
You will receive no payment or other compensation for taking part in this 
study. The findings from this research may result in the future development 
of products that are of commercial value. There are no plans to provide you 
with financial compensation or for you to share in any profits if this should 
occur.
WHO IS SPONSORING THIS STUDY?
This study is being sponsored by Wake Forest Baptist Health Department of 
Urology. The sponsor is providing money or other support to Wake Forest 
University Health Sciences to help conduct this study. The researchers do not, 
however, hold a direct financial interest in the sponsor or the product being 
studied.
WHAT HAPPENS IF YOU EXPERIENCE AN INJURY OR ILLNESS AS A
RESULT OF PARTICIPATING IN THIS STUDY?
Should you experience a physical injury or illness as a direct result of your 
participation in this study, Wake Forest University School of Medicine 
maintains limited research insurance coverage for the usual and customary 
medical fees for reasonable and necessary treatment of such injuries or 
illnesses. To the extent research insurance coverage is available under this 
policy the reasonable costs of these necessary medical services will be paid, 
up to a maximum of $25,000. Wake Forest University Baptist Medical Center 
holds the insurance policy for this coverage. It provides a maximum of 
$25,000 coverage for each claim and is limited to a total of $250,000 for all 
claims in any one year. The Wake Forest University School of Medicine, and 
the North Carolina Baptist Hospitals, Incorporated do not assume 
responsibility to pay for these medical services or to provide any other 
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compensation for such injury or illness. Additional information may be 
obtained from the Medical Center’s Director of Risk and Insurance
If you are injured, the insurer may require information such as your name, 
social security number, and date of birth in order to pay for your care. This is 
because the insurer is required by law to report any payments made to cover 
the care of any persons who are members of a government insurance plan to 
the Department of Health and Human Services. You do not give up any legal 
rights as a research participant by signing this consent form. For more 
information on medical treatment for research related injuries or to report a 
study related illness, adverse event, or injury you should call Drs. Majid 
Mirzazadeh (principle investigator) or Amr El Haraki (research study co-
investigator) at 
, 24 hours a day and 7 days a week.
WHAT ABOUT MY HEALTH INFORMATION?
In this research study, any new information we collect from you and/or 
information we get from your medical records or other facilities about your 
health or behaviors is considered Protected Health Information. The 
information we will collect for this research study includes: postvoid residual 
measurement, urinalysis, urinary symptom questionnaires 
If this research study involves the diagnosis or treatment of a medical 
condition, then Protected Health Information collected from you during this 
study will be placed in your medical record, and may be used to help treat 
you, arrange payment for your care, or assist with Medical Center operations.
We will make every effort to keep your Protected Health Information private. 
We will store records of your Protected Health Information in a cabinet in a 
locked office or on a password protected computer. Your personal health 
information and information that identifies you (“your health information”) 
may be given to others during and after the study. This is for reasons such as 
to carry out the study, to determine the results of the study, to make sure the 
study is being done correctly, to provide required reports and to get approval 
for new products. Some of the people, agencies and businesses that may 
receive and use your health information are the research sponsor; 
representatives of the sponsor assisting with the research; investigators at 
other sites who are assisting with the research; central laboratories, reading 
centers or analysis centers; the Institutional Review Board; representatives of 
Wake Forest University Health Sciences and North Carolina Baptist Hospital; 
representatives from government agencies such as the Food and Drug 
Administration (FDA) or the Office of Human Research Protections (OHRP), 
the Department of Health and Human Services (DHHS) and similar agencies 
in other countries. Your health information may be disclosed if required by 
law. This information may be used by other researchers. You will not be 
directly identified in any publication or presentation that may result from this 
study unless there are photographs or recorded media which are identifiable. 
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Monitors, auditors, IRB or other regulatory agencies will be granted direct 
access to the participant’s original medical record for verification of clinical 
trial procedures or data, without violating confidentiality of the participant and 
to the extent permitted by other applicable laws.
If required by law or court order, we might also have to share your Protected 
Health Information with a judge, law enforcement officer, government 
agencies, or others. 
If your Protected Health Information is shared with any of these groups it may 
no longer be protected by federal or state privacy rules.
Any Protected Health Information collected from you in this study that is 
maintained in the research records will be kept for at least six years after the 
study is finished. At that time any research information not already in your 
medical record will either be destroyed or it will be de-identified. Any research 
information entered into your medical record will be kept for as long as your 
medical record is kept by the Medical Center. You will not be able to obtain a 
copy of your Protected Health Information in the research records until all 
activities in the study are completely finished.
You can tell Drs. Majid Mirzazadeh or Amr El Haraki that you want to take 
away your permission to use and share your Protected Health Information at 
any time by sending a letter to this address:
Dr. Majid Mirzazadeh and Dr. Amr El Haraki
However, if you take away permission to use your Protected Health 
Information you will not be able to be in the study any longer. 
If you choose to participate in this study, your medical record at Wake Forest 
University Baptist Medical Center will indicate that you are enrolled in a clinical 
trial. Information about the research and any medications or devices you are 
being given as a participant may also be included in your medical record. This 
part of the medical record will only be available to people who have authorized 
access to your medical record. If you are not a patient at this Medical Center, 
a medical record will be created for you anyway to ensure that this important 
information is available to doctors in case of an emergency.
Laboratory test results and other medical reports created as a result of your 
participation in the research study may be entered into the computer systems 
of Wake Forest University Health Sciences and North Carolina Baptist Hospital. 
These will be kept secure, with access to this information limited to individuals 
with proper authority, but who may not be directly involved with this research 
study.
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A North Carolina Baptist Hospital (NCBH) medical record will be created for all 
study participants. Information about your participation in the study will be 
placed in the NCBH medical record, along with any routine medical test results 
that were obtained at NCBH as part of this study. A description of this clinical 
trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This website will not include information that can identify you. 
WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or you 
may leave the study at any time. Refusing to participate or leaving the study 
will not result in any penalty or loss of benefits to which you are entitled. If 
you decide to stop participating in the study we encourage you to talk to the 
investigators or study staff first to learn about any potential health or safety 
consequences. The investigators also have the right to stop your participation 
in the study at any time. This could be because it is in your best medical 
interest, your condition worsened, new information becomes available, you 
had an unexpected reaction, you failed to follow instructions, or because the 
entire study has been stopped. Information that identifies you may be 
removed from the data or specimens that are collected as part of this study 
and could be used for future research or shared with others without additional 
consent.
You will be given any new information we become aware of that would affect 
your willingness to continue to participate in the study.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or in the event of a research-related injury, 
contact the study investigator, Amr El Haraki, MD or Majid Mirzazadeh, MD at 
 (24 hours a day, 7 days a week). The Institutional Review Board 
(IRB) is a group of people who review the research to protect your rights. If 
you have a question about your rights as a research participant, or you would 
like to discuss problems or concerns, have questions or want to offer input, or 
you want to obtain additional information, you should contact the Chairman 
of the IRB at 
 or the Research Subject Advocate at 
 You will be given a copy of this signed consent form.
SIGNATURES
I agree to take part in this study. I authorize the use and disclosure of my 
health information as described in this consent and authorization form. If I 
have not already received a copy of the Privacy Notice, I may request one or 
one will be made available to me. I have had a chance to ask questions about 
being in this study and have those questions answered. By signing this consent 
and authorization form, I am not releasing or agreeing to release the 
investigator, the sponsor, the institution or its agents from liability for 
negligence.
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Subject Name (Printed):_____________________________
Subject Signature: _________________________________ 
Date: ________Time:_______ am pm
Person Obtaining Consent (Printed):_____________________________
Signature of person obtaining consent:___________________________ 
Date:_________ Time:________ am pm
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Prot_SAP_003.pdf: 
Official Title:   Evaluating the effect of Tamsulosin on Postoperative Urinary Retention 
in Women undergoing Same Day Hospital Discharge Following Pelvic Reconstructive 
Surgery: A Randomized Trial 
 
 
NCT04682366 
 
IRB-Approved Date: 8/19/2021 
 
 


2 
 
 
Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
Wake Forest Baptist Medical Center 
 
 
Evaluating the effect of Tamsulosin on Postoperative Urinary Retention in Women 
undergoing Same Day Hospital Discharge Following Pelvic Reconstructive Surgery: A 
Randomized Trial 
 
 
MANUAL OF PROCEDURES/PROTOCOL  
 
Investigators:  
A. Amr El Haraki 
B. Catherine Matthews 
C. Candace Parker-Autry 
D. M. Mirzazadeh 
 
 
 
 
 
 
                                 
 
 
 


3 
 
 
Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
Index 
 
I. 
Abstract 
II. 
Background 
III. 
Study Objectives 
IV. 
Study Design 
V. 
Study Objectives 
VI. 
Subject selection: Inclusion/exclusion 
VII. 
 Pre-intervention assessments 
VIII. 
Randomization 
IX. 
Study intervention 
X. 
Post-intervention assessments 
XI. 
Power calculation 
XII. 
Calendar of events 
XIII. 
Data collection and management 
XIV. 
Study monitoring and documentation 
XV. 
Reporting adverse events 
XVI. 
Subject protections 
XVII. 
References 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


4 
 
 
Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
 
 
Background 
Postoperative urinary retention (POUR) is a significant postoperative complication in 14-
16% of all surgeries (Kowalik) and 21-50% following female pelvic reconstructive surgery 
(Ripperda). POUR is associated with increased risk of urinary tract infection and 
healthcare costs (Hooten) as well as decreased patient satisfaction (Kenton).  
The bladder neck and urethra are rich in α-adrenergic receptors. One potential 
mechanism by which POUR occurs following female pelvic reconstructive surgery is 
disruption of the local autonomic nervous system, increasing sympathetic drive to the 
bladder outlet and inhibiting urethral relaxation and bladder emptying. The prophylactic 
use of α-AR antagonists before the onset of symptoms may decrease the incidence of 
POUR after urologic and colorectal surgery in men (Ghuman, Akkoc, Poylin, Claney). 
Recently, a retrospective matched cohort study by Chapman et al. showed a significantly 
decrease risk of POUR with the use of tamsulosin following female pelvic reconstructive 
surgery. In this study, active voiding trials were performed on postoperative day 1 for 
the tamsulosin group. In a follow-up double-blinded randomized controlled trial, a 10-
day course of tamsulosin started 3 days preoperatively vs. placebo showed a reduction 
in POUR from 24.6% in the placebo group to 8.7% in the tamsulosin group (Chapman). 
The voiding trials in this study were performed on postoperative day 1. 
With enhanced recovery after surgery protocols, same-day discharge has become a 
common phenomenon with female pelvic reconstructive surgery. It is safe and cost 
effective for patients with no increase in postoperative complications as compared to an 
overnight stay (Schiavone, Jennings, Carter-Brooks). Same day hospital discharge with 
voiding trials performed on the day of procedure, however, may be associated with 
even higher rates of acute POUR. In our unit, at least 50% of women undergoing 
multicompartment native tissue vaginal repair, who are discharged on the same day, 
have to perform either self-catheterization or have an indwelling Foley catheter which 
increases patient burden and risk of UTIs. It may also decrease overall patient 
satisfaction.  
The purpose of this double-blind, randomized controlled trial is to determine the 
difference in incidence of POUR following a postoperative day 0 voiding trial in patients 
undergoing multicompartment native tissue vaginal repair of pelvic organ prolapse, with 
or without concomitant mid-urethral sling, who received 0.4 mg of tamsulosin 5 days 
pre- and post-operatively compared to those who receive placebo. The 5-day period 
was determined based on the pharmacokinetics of tamsulosin. Given the recent trend in 


5 
 
 
Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
same-day discharge, increasing the success of postoperative day 0 voiding trial would 
theoretically decrease the percentage of patients going home with indwelling Foley 
catheters, increase patient satisfaction and decrease urinary tract infection rates. 
Additionally, continuing tamsulosin for 5 days postoperatively to prevent decrease in 
steady-state blood levels may theoretically reduce the incidence of delayed urinary 
retention. 
Specific Aims 
Primary Aim(s):  
(1) To compare rates of POUR following an active voiding trial on postoperative 
day 0 between women undergoing multicompartment, native tissue vaginal 
repair that received perioperative tamsulosin versus women that received 
placebo 
Secondary Aim(s):  
(1) To compare the mean total number of days of postoperative catheterization, 
incidence of delayed urinary retention and urinary tract infection rates up to 
6 weeks post-surgery between groups  
(2) To compare ED visits  and serious adverse events, as classified by Clavien-
Dindo, between groups 
(3) To compare patient level of satisfaction with voiding function immediately 
prior to hospital discharge and at 1 week post-procedure. 
Hypothesis  
Peri-operative administration of tamsulosin decreases the incidence of POUR on 
postoperative day 0 in female patients who undergo multicompartment native tissue 
vaginal repair compared to those who receive placebo.  
 
 
Keywords:  
ERAS (enhanced recovery after surgery) 
POUR (postoperative urinary retention) 
FPRS (female pelvic reconstructive surgery) 
IP (investigational product) 
FPMRS (female pelvic medicine and reconstructive surgery) 


6 
 
 
Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
Study Design 
This is a double-blind, randomized controlled trial. Both investigators and participants 
will remain blinded to the intervention. All surgery will be performed by FPMRS board-
certified urogynecologists. The patients will be able to have a revealing of the 
intervention they received at 6 weeks post-surgery 
 
Outcomes 
Primary 
 
To compare rates of POUR following an active voiding trial on postoperative day 
0 between women undergoing multi-compartment native tissue vaginal repair 
that received preoperative tamsulosin 5 days preoperatively and continued 5 
days post operatively versus a group that received placebo 
Secondary: 
To compare the following between the two groups: 
1. Postoperative urinary tract infection rates (up to 6 weeks post-surgery) 
2. Incidence of delayed urinary retention (defined as PVR > 150 ml up to 6 
weeks post-surgery) 
3. ED visits and serious adverse events within 30 days post procedure 
4. Total number of days of catheterization  
5. Patient level of satisfaction with voiding/bladder function immediately prior 
to hospital discharge: Very dissatisfied, moderately dissatisfied, slightly 
dissatisfied, neutral, slightly satisfied, moderately satisfied, very satisfied 
 
Inclusion criteria: 
1. Stage II or greater pelvic organ prolapse in > 1 vaginal compartment 
2. Plan for multicompartment native tissue vaginal repair  (which would include any 
combination of uterosacral ligament suspension, sacrospinous ligament 
suspension, cystocele and/or rectocele repair, with or without hysterectomy and 
with or without concomitant mid-urethral sling) or vaginal closure with FPMRS-
trained surgeons at Wake Forest Baptist Health.  
3. Participation in Enhanced-Recovery-After-Surgery protocol with plan for same-
day hospital discharge 
4. Willing to remain compliant with IP. 
 
 


7 
 
 
Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
Exclusion criteria: 
1. Intraoperative complication necessitating prolonged bladder drainage or 
placement of a vaginal pack x 24 hours (patients would exit study after 
randomization and will be excluded from the per-protocol analysis) 
2. Patients whose surgical plan would necessitate a voiding trial on postop day >0 
3. Less than 21 years of age  
4. Unable to understand English 
5. Patients who are scheduled to undergo combined colorectal procedures such as 
rectopexy, sphincteroplasty 
6. Patient with known allergy to tamsulosin or sulfa drugs 
7. Patients with upcoming cataract surgery 
8. Patient with orthostatic hypotension 
9. History of postvoid residual (PVR>150) prior to surgery with prolapse reduction 
10. Patients with hypertension on alpha-blockers 
11. Single compartment prolapse repair (anterior or posterior repair only) 
12. Use of mesh for prolapse repair 
13. High tone pelvic floor dysfunction 
 
 
 
Pre-Assessment – 
All women scheduled to undergo multicompartment native tissue vaginal repair with 
plan for same day surgical discharge will be screened for their eligibility. If eligible and 
consenting, the following baseline data will be collected on paper forms that will then 
be transcribed into a secure REDCap (Research Electronic Data Capture) Database: 
  
1.   Demographic data including age, race, BMI, zip code    
2.   Medical and Surgical History 
3.   Menopausal status, including current exposure to topical vaginal estrogen 
4.   Type of planned surgical procedure 
5.   Plan for concomitant sling placement 
6.   Assessment of post-void residual volume (collected via bladder scan or CIC) 
 
  
Randomization - 
  
All enrolled and consented patients will undergo randomization at their pre-operative 
clinic visit. A study patient can be randomized into either tamsulosin IP or Placebo IP 
group. Randomization assignment will occur through sealedenvelope.com-generated 
random allocation using a randomly permutated block design (8 subjects per block). An 


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Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
unblended designated person who will not participate in data collection or analysis will 
be responsible for providing randomization schedule. Study staff will dispense the 
assigned IP bottle (see below) in the urology clinic. Study patient charts will get updated 
with the IP ID (e.g. 01A, 02A, 01B, 02B…).  Research staff administering follow-up 
questionnaires will also be blinded to the subject’s randomization. The subject will be 
asked to bring back their IP bottle at the time of their postoperative visit.  
  
Study Intervention –  
10 pills of each IP and placebo will be placed in identical coded containers and stored in 
a locked area in the clinic. Instructions for IP usage will be provided to subjects for 10 
days of usage as 0.4 mg qd by PO route starting 5 days prior to day of surgery and 
continued for a total 10 days. The research manager will be the only member of the 
study team who has the research key designating which containers are IP versus 
placebo.  
 
On postoperative day 0 after recovery from anesthesia, each patient will have their 
bladder emptied using the indwelling Foley and their bladder will then be retrograde-
filled with 300 cc of normal saline and given 30 minutes to void. A postvoid residual 
volume<150 cc will be considered a success of the voiding trial. If the voiding trial was 
considered failed, the patient will have a foley catheter reinserted and the patient will 
be instructed to remove the catheter at home after having a bowel movement. If they 
are unable to void at home within 4 hours of catheter removal, they will return to the 
Wake Forest Urology clinic for self-catheter teaching.  
 
IP Accountability – 
Baseline preoperative visit:
- Consent
- Dispense IP
- Satisfaction questionnaire
Day of surgery
- Voiding trial
- PVR
- Satisfaction questionnaire
Week 1 postoperative visit
- PVR
- UA
- Satisfaction questionnaire
- Return IP bottle
Week 6 postoperative visit
- PVR
- UA
Day of surgery
- Voiding trial
- PVR
- Satisfaction questionnaire 
Week 1 postoperative visit
- PVR
- UA
- Satisfaction questionnaire
- Return IP bottle
Week 6 postoperative visit
- PVR
- UA


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Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
IP and placebo bottles will be stored in a locked cabinet on the clinic premises. They will 
be dispensed to the patient at the time of consent collection and will be brought back 
by the patient at time of the 1-week postoperative visit. This will be recorded in a study 
log to keep track of bottles signed in and out. The bottles as well as log will be stored for 
long-term archiving.  
 
Post-Surgery Assessments – 
Postoperative day 0 voiding trial result 
For women who fail initial trial of void, post-operative day when bladder function 
returned 
Postoperative exam at 1 and 6 weeks 
Pelvic examination at 6 weeks 
Data points to be collected:  
Post-void residual (PVR), urinalysis (UA), patient level of satisfaction (1-7 – very 
dissatisfied, moderately dissatisfied, slightly dissatisfied, neutral, slightly satisfied, 
moderately satisfied, very satisfied) 
 
Power analysis 
For a superiority study, if we assume 5% significance level and 80% power with internal 
audit rates of POUR of 24.3% for the control group and expecting 2.9% for the 
tamsulosin group (Chapman), then total sample size would be approximately 74 with n= 
37 in each group. Accounting 20% non-compliant and dropout rate, we expect to enroll 
88 patients total with 44 in each group. Power calculations done with 
sealedenvelope.com 
  
Statistical analysis will be performed using IBM SPSS Statistics 24 or similar program. 
  
  
Baseline and demographic data will be reported using standard descriptive methods. 
Scores of questionnaires (age, race, BMI, insurance, smoking y/n) and clinical 
evaluations (menopausal status, vaginal atrophy y/n, estrogen use, type of surgery etc.) 
will be calculated appropriately. Outcomes will be presented as number with proportion 
for categorical data and mean and standard deviation (in case of normally distributed 
data) or median with interquartile range (in case of not normally distributed data). 
Comparisons within groups will be done for numerical data using either paired t-test (in 
case of normally distributed data) or Wilcoxon signed rank test (in case of not normally 
distributed data) and Fisher exact test or Mcnemar for categorical data. Between-group 
comparisons will be done using either unpaired t-test (in case of normally distributed 


10 
 
 
Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
data) or Mann-Whitney U test (in case of not normally distributed data) and Chi-square 
test for categorical data. 
  
Calendar of Events 
 
Baseline 
Day of surgery 
Week 1 post-
operative visit 
Week 6 
postoperative 
visit 
Consent 
x 
 
 
 
Dispense IP 
x 
 
 
 
Voiding trial 
 
x 
 
 
PVR 
x 
x 
x 
x 
UA 
x 
 
x 
x 
Level of 
satisfaction 
with voiding 
function (1-7) 
x 
x 
x 
 
Return IP 
bottle 
 
 
x 
 
 
Data Collection and Management – 
  
Data collection will occur at each visit outlined in the Calendar of Events.  All study data 
will be recorded on data collection forms (CRFs: Case Report Forms) designed by the 
research manager (Sachin Nalin Vyas, MS, PhD), and securely maintained.  Any 
discrepancies between data collection forms and supporting source documents such as 
physician’s notes should be explained on the forms.  Any changes made to original 
entries on data collection forms should be crossed through with a single line and initial 
and dated by the person making the correction.  Do not obscure the original entry.  
  
Data will be entered by study manger’s staff into a REDCap Database (described in detail 
in the “STUDY SUBJECT PROTECTION” section of this protocol) that will be stored on a 
secure server by the study center (WF: Wake Forest University).  Study data source 
documentation and progress notes will be monitored by the PI (principal Investigator) as 
outlined in the “STUDY MONITORING AND DOCUMENTATION” section.  Data collected 
from visits should be entered into REDCap within 5 business days.  Any queries to data 
entered into REDCap should be addressed within 5 business days.  
  
WF site will maintain all essential study documents in original format and source 
documentation that support the data collected on study participants in compliance with 
ICH/GCP guidelines.  Documents must be retained until at least 2 years have elapsed 


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Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
since the formal discontinuation of the clinical investigation.  Research Center WF 
Urology Female Pelvic Health Group PI will be responsible to ensure that these essential 
documents are retained and are not accidentally damaged or destroyed prior to the 
required elapsed time.  
  
Study Monitoring and Documentation 
  
Study Monitoring 
  
The PI at the WF center will monitor the study and assess the need for amendments as 
the study progresses.  If a protocol revision is necessary for reasons including but not 
limited to the rights, safety, or welfare of participants, or scientific integrity of the data, 
an amendment is required.  IRB (Institutional Review Board) or equivalent approvals of 
the revised protocol—and if necessary, revised informed consent—must be obtained 
prior to implementation at each site.  
  
Data Monitoring  
Semi-annual data verification will be conducted by the research manager to verify that 
data entry into REDCap is accurate, and to assess compliance with the study protocol 
requirements.  Study data will be source-verified for roughly 25% of overall data 
collection efforts.  Progress notes and supporting documents will be obtained from the 
EPIC WakeOne within 3 days of procedure and scheduled visits. Other monitoring 
activities include but are not limited to reviewing informed consent/research 
authorization forms, adverse event documentation, and protocol deviation reports.   
  
Protocol Deviations - 
Protocol deviations will be documented in sequential order according to event of 
occurrence and they will be entered into REDCap.  
  
Reporting Adverse Events: 
In a study by Kaplan, AE’s in women and children were abdominal pain, asthenia, 
constipation, dizziness, dry mouth, drowsiness, dyspepsia, headache, incontinence, 
nasal congestion, nausea, orthostatic hypotension, and somnolence.  
The overall safety profile in women seemed to be generally consistent with the profile in 
men. 
Patients will initially be screened for these adverse events on postoperative day 1 via 
telephone call.  


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Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
Adverse events (AEs) will be recorded and reported to local IRB as per regulations on 
Serious Adverse Event reporting guideline. Post-operative and surgical attributed AEs 
will be defined using the Clavien-DINDO grading 
  
TABLE 1. Classification of Surgical Complications Clavien-DINDO Grade Definition for 
surgery attributed post-op events only 
  
Grade 1 
Any deviation from the normal postoperative course without the 
need for pharmacologic treatment. Allowed therapeutic 
interventions are: drugs as antiemetics, antipyretics, analgesics, 
physiotherapy 
Grade II 
Requiring pharmacological treatment with drugs other than such 
allowed for grade I complications Blood transfusions and total 
parenteral nutrition are also included 
Grade III 
  
     IIIA 
     IIIB 
  
Requiring surgical, endoscopic or radiological intervention 
       Intervention not under general anesthesia 
       Intervention under general anesthesia 
Grade IV 
  
    IVA 
    IVB 
Life-threatening complication (including CNS complications)* 
requiring IC/ICU management        
Single organ dysfunction (including dialysis)  
Multi-organ dysfunction 
Grade V 
Death 
  
  
Protocol Specific Reportable AEs include those determined to be related to 
postoperative recovery as listed below:  
Surgery or catheter-related: 
Infection (UTI, Vaginal, Pelvic Abscess) 
Venous Thromboembolism 
Pelvic pain 
Surgical bleeding (Significantly higher estimated blood loss) 
Vaginal bleeding (Unexpected bleeding following sexual activity) 
Excessive vaginal discharge 
Fistula 
New or worsening dyspareunia 
Hematoma 
Urgency ‘de novo’ 
Stress or Urgency Incontinence (New or worsening) 


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Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
Urinary retention (PVR>150) longer than 2 weeks post-surgery 
 
Medication-related:  
Orthostatic hypotension/dizziness 
Postoperative atrial fibrillation 
Abdominal pain 
Asthenia 
Constipation 
Dry mouth 
Drowsiness 
Dyspepsia 
Headache 
Nasal congestion 
Nausea 
Somnolence 
 
Underlying diseases are not reportable as AEs unless there is an increase of severity or 
frequency during the course of the study.  If an AE has not resolved at the time of AE 
Form completion, save form as incomplete in REDCap until resolved. Once resolved, 
update AE form, and enter into REDCap and save form as complete. 
  
Adverse Event Definitions: 
Adverse Event: any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including abnormal laboratory finding) in subjects, whether or 
not related to the administration of IP versus placebo. 
  
Serious Adverse Event: an adverse event that 
Led to death 
Led to serious deterioration in the health of the subject that either resulted in 
- a life-threatening illness or injury 
- a permanent impairment of a body structure or a body function in subject or 
prolonged hospitalization of existing hospitalization 
- medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function 
  
Adverse Event Severity: 
  
Mild: Awareness of signs or symptoms, but easily tolerated and are of minor irritant 
type causing no loss of time from normal activities. Symptoms do not require therapy or 
a medical evaluation; signs and symptoms are transient. 


14 
 
 
Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
  
Moderate: Events introduce a low level of inconvenience or concern to the participant 
and may interfere with daily activities, but are usually improved by simple therapeutic 
measures; moderate experiences may cause some interference with functioning. 
  
Severe: Events interrupt the participant’s normal daily activities and generally require 
systemic drug therapy or other treatment; they are usually incapacitating. 
  
Relationship of AE to Operative Procedures: 
  
Unrelated: No evidence that the timing if the AE has a relationship to the administration 
of study drug. 
Possibly Related: The AE has a timely relationship to the study drug, however a potential 
alternative etiology may be responsible for the AE. 
Probably Related: The AE has a timely relationship to the study drug and the causative 
relationship can clearly be established. No potential alternative etiology is apparent. 
  
Study Subject Protection 
  
Protection of each subject’s personal health information will be a priority in this study. 
One master file in Microsoft Excel Format containing subject personal information 
including name and medical record number will be kept in a password-protected file, on 
a designated protected research drive on a password-protected computer in a locked 
office at each respective institution. In that file, each subject will be assigned a subject 
identification number that will be used for the purposes of data collection. 
  
All paper forms used for data collection will be kept in a research cabinet dedicated to 
this project, which will be locked at all times, in a locked office at Wake Forest Baptist 
Health, Urology Department, Research Office at Charlois Blvd Clinic. Identification 
numbers of study patients must correspond to the subjects listed in the master file. 
  
All study data will be transferred and managed electronically using REDCap. Each subject 
will be entered into REDCap using the assigned identification number. REDCap is a 
secure, web-based application designed to support data capture for research studies, 
providing user-friendly web-based case report forms, real-time data entry validation, 
audit trials, and a de-identified data export mechanism to common statistical packages. 
The system was developed by a multi-institutional consortium that was initiated at 
Vanderbilt University and includes Wake Forest Baptist Health. The database is hosted 
within the Clinical and Translational Research Unit at Wake Forest and is managed by 
the Quantitative Health Sciences Department. The system is protected by a login and 


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Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
Secure Sockets Layers (SSL) encryption. Data collection is customized for each study as 
based on a study-specific data dictionary defined by the research team with guidance 
from the REDCap administrator in Quantitative Health Sciences at Wake Forest. 
 
Project Schedule: 
November-December: Protocol finalization, submission to WISER and IRB   
March 2021-April 2022: Patient enrollment and date collection 
April 2022 – May 2022: Data analysis/Submission 
 
 


16 
 
 
Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
 
 
 
Appendix A: Data Collection Variables 
Demographics: 
- Age at time of Surgery 
- Race 
- zip code 
- Height/ Weight or BMI 
- Parity 
- Menopausal status 
- Current estrogen use: systemic, vaginal, both, none 
- Smoking status: none, past, current 
- Preoperative PVR 
- Preoperative anti-cholinergic use 
- Preoperative UDS parameters (Qmax, Pdet at Qmax, Cough/Valsalva LPP) 
- Prior Pelvic Surgery (None, Reconstructive, Anti-Incontinence, C/S, Laparoscopy, Other) 
-Diabetes 
- Preop POPQ Exam 
- Stage of prolapse  
- Leading edge of prolapse compartment (anterior, apical, posterior) 
 
Surgery  
- Month/Year of Surgery 
- Hysterectomy if performed and type (vaginal, laparoscopic, open) 
- Vaginal colporrhaphy if performed and type (anterior, posterior) 
- Apical vaginal suspension if performed and type (Sacrospinous, uterosacral) 
- Vaginal closure 
- High perineorrhaphy 
- Stress Incontinence Procedure: None, RP sling, single-incision sling, TOT 
-  
- Other concomitant procedures 
- EBL 
 
Postop parameters  
- Active voiding trial PVR on POD 0 
- Day of bladder function return 
- UTI within 6 weeks 
- Persistent urinary retention > 2 weeks 
- Delayed urinary retention (PVR > 150 after passing 1st trial of void) 
- Emergency Room visit/evaluation 


17 
 
 
Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
Reconstructive Surgery 
 
- Readmission within 30 days 
- Reoperation for complication within 30 days 
- Other (including: Delayed urinary tract injury, Delayed bowel injury, Hematoma, 
Transfusion, Cardiac complication, Respiratory complication)  
 
Postoperative Follow Up 
- 1 and 6 week follow up visits with PVR  
 
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