Evaluating the Effect of Tamsulosin on Postoperative Urinary Retention in Women Undergoing Same Day Hospital Discharge Following Pelvic Reconstructive Surgery: A Randomized Trial
Phase: PHASE4
Conditions: Urinary Retention
Sponsor: Wake Forest University Health Sciences

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 
 
 

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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 
 
 
 
 
 
 
                                 
 
 
 

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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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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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 

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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) 

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Tamsulosin to Prevent Postoperative Urinary Retention in ERAS Patients Following Pelvic 
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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. 
 
 

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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 
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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 

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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 
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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. 

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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 
 
 

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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 

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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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1.  
Wein A, Dmochowski R. Neuromuscular dysfunction of the lower urinary tract. 
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2.  
Chapman, G. C. (2020). "TAMSULOSIN VERSUS PLACEBO TO PREVENT 
POSTOPERATIVE URINARY RETENTION FOLLOWING FEMALE PELVIC 
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Chong, C., Kim, H. S., Suh, D. H., & Jee, B. C. (2016). Risk factors for urinary 
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Clancy, C., Coffey, J. C., O'Riordain, M. G., & Burke, J. P. (2018). A meta-analysis 
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Costantini, E., Lazzeri, M., Bini, V., Zucchi, A., Fioretti, F., Frumenzio, E., & Porena, 
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Doll, K. M., Dusetzina, S. B., & Robinson, W. (2016). Trends in Inpatient and 
Outpatient Hysterectomy and Oophorectomy Rates Among Commercially 

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Insured Women in the United States, 2000-2014. JAMA Surg, 151(9), 876-877. 
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Hooton, T. M., Bradley, S. F., Cardenas, D. D., Colgan, R., Geerlings, S. E., Rice, J. 
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