Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03524339
• Collaborator: (none)
• Enrollment: 132
• Locations: 2
• Arms: 2
• Actual Duration (Months): 22.3
• Patients Per Site: 66
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention; Lower Urinary Tract Symptoms; Stress Urinary Incontinence; Pelvic Organ Prolapse	Drug: Placebo oral capsule; Drug: Tamsulosin	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Perioperative Administration of Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
• Actual Study Start Date: Aug 1, 2018
• Actual Primary Completion Date: Jun 9, 2020
• Actual Study Completion Date: Jun 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo oral capsule; 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.
Experimental: Tamsulosin	Drug: Tamsulosin; 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.

Outcome Measures

Primary Outcome Measures

1. Postoperative Urinary Retention [Within 72 hours of surgery]

   Failed voiding trial upon removal of catheter

Secondary Outcome Measures

1. International Prostate Symptom Score [Within 1 week of surgery]

   Total and subscale scores reported. Total score range 0-35, with 0 being less symptomatic and 35 being more symptomatic. Total score is sum of individual questions. Seven subgroups address incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia. Each subgroup is scored 0-5 with 5 being most symptomatic. The last question is independent, rates quality of life from 0 (best) to 6 (worst)

2. Postoperative Urinary Tract Infection [Within 6 weeks after surgery]

   Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection.

3. Sent Home With Catheterization [within 6 weeks of surgery]

   Urinary retention that required homegoing catheterization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• Planned bladder catheterization greater than 24 hours after surgery

• Current use of alpha antagonist medication for hypertension

• End stage renal or liver disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
2	University Hospitals	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center

Investigators

• Principal Investigator: Graham Chapman, University Hospitals Case Western Reserve University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 1, 2019

More Information

Publications

• 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. doi: 10.1590/S1677-5538.IBJU.2015.0256.
• Chong C, Kim HS, Suh DH, Jee BC. Risk factors for urinary retention after vaginal hysterectomy for pelvic organ prolapse. Obstet Gynecol Sci. 2016 Mar;59(2):137-43. doi: 10.5468/ogs.2016.59.2.137. Epub 2016 Mar 16.
• 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. doi: 10.1097/AOG.0000000000001750.
• FitzGerald MP, Brubaker L. The etiology of urinary retention after surgery for genuine stress incontinence. Neurourol Urodyn. 2001;20(1):13-21.
• Hakvoort RA, Dijkgraaf MG, Burger MP, Emanuel MH, Roovers JP. Predicting short-term urinary retention after vaginal prolapse surgery. Neurourol Urodyn. 2009;28(3):225-8. doi: 10.1002/nau.20636.
• 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. doi: 10.1590/S1677-5538.IBJU.2014.01.05.
• 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. doi: 10.1007/s00384-015-2294-7. Epub 2015 Jun 23.
• 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.
• 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; discussion 240.
• 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. doi: 10.1038/ijir.2017.12. Epub 2017 Apr 20. Review.

• Responsible Party: Graham Chapman, Principal Investigator, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT03524339
• Other Study ID Numbers: Tamsulosin for POUR
• First Posted: May 14, 2018
• Last Update Posted: Nov 8, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress; Urinary Retention; Prolapse; Pelvic Organ Prolapse; Lower Urinary Tract Symptoms; Tamsulosin

Study Results

Participant Flow

Arm/Group Title	Placebo	Tamsulosin
Arm/Group Description	Placebo oral capsule: 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.	Tamsulosin: 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.
Period Title: Overall Study
STARTED	66	66
COMPLETED	57	62
NOT COMPLETED	9	4

Baseline Characteristics

Arm/Group Title	Placebo	Tamsulosin	Total
Arm/Group Description	Placebo oral capsule: 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.	Tamsulosin: 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.	Total of all reporting groups
Overall Participants	57	62	119
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.6 (10.9)	61.0 (9.7)	61.3 (10.3)
Sex: Female, Male (Count of Participants)
Female	57 100%	62 100%	119 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 3.5%	0 0%	2 1.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	8 14%	6 9.7%	14 11.8%
White	47 82.5%	56 90.3%	103 86.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	57 100%	62 100%	119 100%

Outcome Measures

1. Primary Outcome

Title	Postoperative Urinary Retention
Description	Failed voiding trial upon removal of catheter
Time Frame	Within 72 hours of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Tamsulosin
Arm/Group Description	Placebo oral capsule: 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.	Tamsulosin: 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.
Measure Participants	62	57
Count of Participants [Participants]	16 28.1%	5 8.1%

2. Secondary Outcome

Title	International Prostate Symptom Score
Description	Total and subscale scores reported. Total score range 0-35, with 0 being less symptomatic and 35 being more symptomatic. Total score is sum of individual questions. Seven subgroups address incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia. Each subgroup is scored 0-5 with 5 being most symptomatic. The last question is independent, rates quality of life from 0 (best) to 6 (worst)
Time Frame	Within 1 week of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Tamsulosin
Arm/Group Description	Placebo oral capsule: 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.	Tamsulosin: 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.
Measure Participants	37	35
Median (Inter-Quartile Range) [Points]	6	7

3. Secondary Outcome

Title	Postoperative Urinary Tract Infection
Description	Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection.
Time Frame	Within 6 weeks after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Tamsulosin
Arm/Group Description	Placebo oral capsule: 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.	Tamsulosin: 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.
Measure Participants	62	57
Count of Participants [Participants]	6 10.5%	4 6.5%

4. Secondary Outcome

Title	Sent Home With Catheterization
Description	Urinary retention that required homegoing catheterization
Time Frame	within 6 weeks of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Tamsulosin
Arm/Group Description	Placebo oral capsule: 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.	Tamsulosin: 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.
Measure Participants	62	57
Count of Participants [Participants]	7 12.3%	5 8.1%

Adverse Events

Time Frame	Three days prior to surgery through five days after surgery (10d total)
Arm/Group Title	Placebo		Tamsulosin
Arm/Group Description	Placebo oral capsule: 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.		Tamsulosin: 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.
All Cause Mortality
	Placebo		Tamsulosin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/62 (0%)		0/57 (0%)
Serious Adverse Events
	Placebo		Tamsulosin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/62 (3.2%)		1/57 (1.8%)
Cardiac disorders
Development of atrial fibrillation	0/62 (0%)		1/57 (1.8%)
Congestive heart failure	1/62 (1.6%)		0/57 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary edema	1/62 (1.6%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Tamsulosin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/62 (4.8%)		3/57 (5.3%)
Nervous system disorders
Dizziness/lightheadedness	3/62 (4.8%)		3/57 (5.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.