Clinical trial NCT03524339
Conditions: Urinary Retention Lower Urinary Tract Symptoms Stress Urinary Incontinence Pelvic Organ Prolapse
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2018-08-01; Completion date: 2020-06-09
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo oral capsule intervention 2: Tamsulosin
Intervention descriptions: intervention 1: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention. intervention 2: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.

Protocol documents:
Prot_SAP_000.pdf: 
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TITLE:  Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic 
Reconstructive Surgery 
NCT03524339 
1/1/19 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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BACKGROUND:  
Postoperative urinary retention (POUR) is a well-known risk of surgery, and is particularly common in 
urogynecologic surgery.  While acute POUR has a high rate of eventual resolution after discharge home 
with a catheter for 5-7 days, this is uncomfortable and inconvenient for the patient, increases the 
likelihood of urinary tract infection, and increases healthcare costs.  In patient surveys, being discharged 
home from the hospital with a catheter is considered to be a surgical complication, and is rated as one 
of the worst potential aspects of surgery.  Reported rates of POUR in urogynecologic surgery are 
variable, ranging from to 21-50% (1, 2, 3).  In our practice the rate is estimated to be around 30%.  Risk 
factors for developing POUR in this population have been identified, most notably high grade cystocele, 
higher intra-operative blood loss, urinary retention prior to surgery, and early removal of foley catheter 
in elderly patients (1, 2).  The etiology for POUR is not completely understood, but multiple factors are 
suspected to play a role including postoperative pain resulting in impaired relaxation of pelvic floor 
muscles, decreased bladder detrusor muscle contraction, and involuntary contraction of the external 
urethral sphincter secondary to pain, trauma, or inflammation (4). 
Research has not provided a means to prevent POUR in this patient population.  One therapy that has 
been studied in other fields is use of an alpha receptor antagonist (most commonly tamsulosin), with 
the goal of relaxing musculature in the bladder neck and urethra.  The bladder neck and female urethra 
are known to express alpha receptors.  Inhibition of these receptions causes relaxation of muscle in the 
bladder neck and urethral sphincter, decreasing urethral pressure.  Studies of alpha blockade have 
shown decreased mean and maximal urethral pressure 6 hours after administration of 0.4mg tamsulosin 
in women with lower urinary tract symptoms (5), and increased mean urinary flow rate and lower 
urinary tract symptoms after daily tamsulosin for one month (6).  Metaanalysis and systematic review of 
over 700 women receiving tamsulosin reveals improvement in lower urinary tract symptoms in patients 
with dysfunctional voiding (7) 
Tamsulosin has been studied in other surgical fields to decrease POUR.   Medani et al studied men 
undergoing urologic surgery including varicocelectomy, inguinal herniorrhaphy, and scrotal surgery, and 
randomized patients to placebo versus tamsulosin 0.4mg at 14 and 2 hours before surgery, and 10 hours 
after surgery.  They observed a decrease in POUR from 21.1% to 5.9% (8).  A similar study of patients 
undergoing urologic surgery under spinal anesthesia randomized patients to tamsulosin vs alfuzosin vs 
placebo, and saw an improvement in the rates of POUR with both alpha antagonists compared to 
placebo, but no difference between the two alpha-blockers (9).  A retrospective review of patients 
undergoing colorectal surgery revealed that patients who received perioperative tamsulosin for 3 days 
prior to surgery and after surgery were significantly less likely to experience urinary retention (6.7% vs 
25%) (10).  In a small, retrospective study of our own patients, tamsulosin use was associated with a 
significantly lower rate of POUR (OR 0.11, p=0.03). 
Development of POUR is of significant consequence to patient health and well-being, as well as to 
healthcare costs.  The risk of POUR in patients undergoing female pelvic reconstructive surgery is high.  
Risk factors for POUR in this field have been identified, but there are no available prevention strategies.  
Tamsulosin has been studied in other surgical fields and has been shown to be beneficial to preventing 
POUR.  Determining if tamsulosin is beneficial in preventing POUR in female pelvic reconstructive 
surgery is a significant step in improving healthcare in this field. 
 


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PURPOSE/HYPOTHESIS 
The purpose of this study is to determine if perioperative use of tamsulosin decreases the risk of 
postoperative urinary retention after urogynecologic surgery. 
Study aim 1:  Compare the rates of passage of initial postoperative voiding trial. 
Study aim 2:  Compare the rates of any required bladder catheterization in the postoperative 
period 
Study aim 3:  Compare rates of UTI in the postoperative period 
Hypothesis:  Participants who have received perioperative Tamsulosin will have lower rates of 
postoperative urinary retention following urogynecologic surgery compared to patients who have 
received placebo. 
 
DESIGN: Randomized Controlled Trial.  
 
SETTINGS: Two large academic Institutions.  
 
EXPERIMENTAL DESIGN AND METHODS:  
This will be a multi-institutional randomized controlled trial.  Written consents explicitly explaining the 
risks and benefits of the study will be obtained from the patients.  
 
The inclusion criteria are the following:  
-Patients must be 18 years or older as well as willing and able to provide informed consent 
 -Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence 
 -Standard postoperative plan must include admission to the hospital with foley catheterization 
overnight the night after surgery, and planned removal of foley catheter and active voiding trial on 
postoperative day 1. 
 
The exclusion criteria are the following:  
-Patient unable or unwilling to provide informed consent 
-Severe allergy to sulfa drugs 
-Known allergy to tamsulosin or another alpha antagonist medication 
-History of urinary retention 


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-Planned bladder catheterization greater than 24 hours after surgery 
-Known untreated UTI prior to surgery 
-Current use of alpha antagonist medication for hypertension 
-End stage renal or liver disease  
 
Procedures 
-Once patients are enrolled and consents are obtained, they will be randomized into either tamsulosin 
or placebo group 
-Investigational drug services will provide medication to the study investigators who will provide 
patients with their medication at the preoperative visit, which is typically 1-2 weeks prior to surgery. 
-Patients will be instructed to take one pill by mouth daily for three days prior to surgery. 
-While hospitalized after surgery, patients will continue to take their study medication.  They will take 
one extra pill the morning after surgery, 3-4 hours prior to their voiding trial.  Other than this one extra 
dose, they will continue taking one pill every evening after dinner until their medication has run out.  
This will total 3 days prior, and 6 days after surgery. 
-The voiding trial, which is standard practice after urogynecologic surgery, will be performed the 
morning after surgery.  This will include filling the bladder with 300cc of normal saline or sterile water 
retrograde through the foley catheter, then removing the catheter.  The patient will have 15 minutes to 
void.  The volume of their void will be measured.  If they void 200ml or greater, they have passed the 
voiding trial.  If they void less than 200ml or cannot void at all, they have failed the voiding trial and the 
catheter is reinserted with plans to remove it in the office in 4-6 days.  If the void is not measured or 
cannot be measured for any reason, an ultrasound of the bladder will be performed to determine the 
post-void residual volume in the bladder with a threshold of must void 2/3 of instilled volume.  
-The patient will complete the Voiding Symptom Survey at time of enrollment and again on 
postoperative day 4.  They will be provided with a copy of this form prior to their discharge from the 
hospital.  They will be contacted via telephone to report their results. 
-Data collected will include:  Study number, MRN, age, race, BMI, current tobacco use, parity, ASA class, 
preoperative history of urinary retention, preoperative prescription for medication for overactive 
bladder or urge incontinence, urodynamic testing results (presence of stress urinary incontinence and 
detrusor activity, increased EMG recruitment, post-void residual, peak flow rate, detrusor pressure at 
peak flow rate), preoperative diagnosis particularly of stress urinary incontinence or pelvic organ 
prolapse, surgery performed, surgical complications, estimated blood loss, voiding trial results, presence 
of POUR, time until resolution of POUR, presence of postoperative urinary tract infection, results of 
postoperative Voiding Symptom Survey. 
 
Data security 


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-Study data will be collected and managed using REDCap electronic data capture tools. REDCap 
(Research Electronic Data Capture) is a secure, web-based application designed to support data capture 
for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for 
tracking data manipulation and export procedures; 3) automated export procedures for seamless data 
downloads to common statistical packages; and 4) procedures for importing data from external sources. 
Identifiable information will be stored in password protected directory accessible only by study 
personnel. Finally, no identifiable information with be shared outside of our institution and all non-
identifiable information will be pooled and released as a group for the final study after statistical 
analysis is complete. After the completion of the statistical analysis phase and a sufficient length of time, 
the file containing the patients' MRNs and study specific unique numerical identifiers will be deleted.  
Patient MRN and unique study specific identifier will be kept until completion of data analysis or >2 
years, whichever is greater. The file containing study specific identifier and other study, as well as 
pooled statistics data, will be kept for a period of greater than 3 years per policy to allow additional 
statistical analysis as may be required for final manuscript revisions. Every attempt to obtain and 
maintain a complete and thorough record of data points will be made by the study staff. In the event 
that any data is unable to be obtained from the usual protocol source, every attempt to obtain the data 
from additional electronic medical record sources will be made. If no data is obtainable, said data point 
will not be placed in statistical analysis and reported as such. 
No paper records will be kept other than the consent forms which will be kept in a locked cabinet in a 
locked office  
Data and Safety Monitoring 
-Data and safety monitoring will be performed by the primary investigators throughout the study to 
ensure all above policies are being followed. Upon receipt of the study drug, patients will be reminded 
of contact information to reach investigators with any questions or concerns.  They will be monitored 
closely in the hospital for any abnormalities which is standard for perioperative care.  Investigators will 
again address any questions or concerns during the scheduled postoperative telephone follow up to 
discuss the questionnaire. The primary investigators will meet monthly to review patient enrollment and 
potential adverse events. Any unexpected or significant adverse event may prompt a preliminary 
statistical analysis and/or immediate halt in enrollment or cancellation of the study. 
-Safety monitoring/event reporting:  study investigators will actively monitor for unanticipated 
problems, adverse events, or protocol deviations, with specific emphasis on any events involving risk to 
subject or others.  Record of these events will be kept in the Safety Monitoring Log.  Monitoring will take 
place during preoperative communication with patient, during hospital stay, at the follow-up phone call, 
and in the postoperative period.  In addition to monitoring and record keeping, events will be reported 
as appropriate.  Unanticipated problems and any adverse events that may change the risk/benefit ratio  
will be reported to the IRB within 3 days of discovery per institutional guidelines.  Serious adverse events 
will be immediately reported to the IRB and the patient’s primary provider as soon as investigator is 
aware of the incident.  Any adverse events that are felt to alter the risk/benefit ratio of the study may 
prompt a review and revision of study protocol and/or consent form.  Non-serious adverse events will 
be kept in the Safety Monitoring Log. 
  


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Statistical considerations 
-Data will be evaluated with descriptive statistics, including means, medians, standard deviations, and 
ranges.  Comparisons between the experimental and control group will be evaluated with univariate and 
multivariate logistic regression as appropriate.  A conservative power analysis was performed and 
determined that a total of 118 (59 in each arm) would be required to achieve a power of 80% with an 
alpha error of 0.05 in order to detect a decrease in the rate of failed void trial from 30% to 10%.  To 
account for a 15% dropout rate we will recruit 136 participants. 
 
OUTCOMES:  
PRIMARY OUTCOME:  pass/fail of voiding trial on the morning after surgery 
SECONDARY OUTCOMES:  development of POUR at any time after surgery, diagnosis of urinary tract 
infection after surgery, Voiding Symptom Survey score 
 
REFERENCES: 
1. Hakvoort RA, Dijkgraaf MG, Burger MP, Emanuel MH, Roovers JP. Predicting short-term urinary 
retention after vaginal prolapse surgery. Neurourol Urodyn 2009;28:225-8 
2. Chong C, Kim HS, Suh DH, Jee BC. Risk factors for urinary retention after vaginal hysterectomy for 
pelvic organ prolapse.  Obstetrics & Gynecology Science. 16 Mar 2016, 59(2):137-143 
3. Espaillat-Rijo L, Siff L, Alas AN, Chadi SA, Zimberg S, Vaish S, Davila GW, Barber M, Hurtado EA.  
Intraoperative Cystoscopic Evaluation of Ureteral Patency: A Randomized Controlled Trial.  Obstet 
Gynecol. 2016 Dec;128(6):1378-1383. 
4. FitzGerald MP, Brubaker L. The etiology of urinary retention after surgery for genuine stress 
incontinence. Neurourol Urodyn. 2001;20(1):13-21. 
5. Reitz A, Haferkamp A, Kyburz T, Knapp PA, Wefer B, Schurch B.  The effect of tamsulosin on the 
resting tone and the contractile behaviour of the female urethra: a functional urodynamic study in 
healthy women.  Eur Urol. 2004 Aug;46(2):235-40 
6. Pummangura N, Kochakarn W.  Efficacy of tamsulosin in the treatment of lower urinary tract 
symptoms (LUTS) in women.  Asian J Surg. 2007 Apr;30(2):131-7. 
7. Zhang HL, Huang ZG, Qiu Y, Cheng X, Zou XQ, Liu TT. Tamsulosin for treatment of lower urinary tract 
symptoms in women: a systematic review and meta-analysis.  Int J Impot Res. 2017 Jul;29(4):148-156 
8. Madani AH, Aval HB, Mokhtari G, Nasseh H, Esmaeili S, Shakiba M, Shakiba RS, Seyed Damavand SM.  
Effectiveness of tamsulosin in prevention of post-operative urinary retention: a randomized double-
blind placebo-controlled study.  Int Braz J Urol. 2014 Jan-Feb;40(1):30-6. 


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9. Akkoc A, Aydin C, Topaktas R, Kartalmis M, Altin S, Isen K, Metin A.  Prophylactic effects of alpha-
blockers, Tamsulosin and Alfuzosin, on postoperative urinary retention in male patients undergoing 
urologic surgery under spinal anaesthesia.  Int Braz J Urol. 2016 May-Jun;42(3):578-84. 
10. Poylin V, Curran T, Cataldo T, Nagle D.  Perioperative use of tamsulosin significantly decreases rates 
of urinary retention in men undergoing pelvic surgery.  Int J Colorectal Dis. 2015 Sep;30(9):1223-8