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Tamsulosin

Phase 2

Urinary Retention | Small molecule | Nephrology |Community Health Systems, Inc.|Last Updated: Nov 8, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment132

FDA Designations

No designations recorded

Clinical trial landscape

Tamsulosin · 1 trial · 4 indications

Phase 2 1
NCT03524339Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive SurgeryUrinary Retention
COMPLETED132 Analytics
PHASE2COMPLETED
Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
Urinary Retention
NCT03524339132
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Study Endpoints

Primary Endpoints

Postoperative Urinary Retention
Within 72 hours of surgery

Failed voiding trial upon removal of catheter

Secondary Endpoints

International Prostate Symptom Score
Within 1 week of surgery
Postoperative Urinary Tract Infection
Within 6 weeks after surgery
Sent Home With Catheterization
within 6 weeks of surgery
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
TamsulosinEXPERIMENTAL -

Interventions

NameTypeDescription
Placebo oral capsuleDRUGTamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
TamsulosinDRUGTamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersYes
Study Sites2

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 cathet...

Countries:United States
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