Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597372
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2020-10-05
Brief Title:
Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery
Sponsor:
Allegheny Singer Research Institute also known as Allegheny Health Network Research Institute
Organization:
Allegheny Singer Research Institute also known as Allegheny Health Network Research Institute
Study Overview
Official Title:
The Impact of Tamsulosin on Duration of Post-Operative Urinary Retention in Women Undergoing Pelvic Reconstructive Surgery- A Double Blind Randomized Placebo-Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention POUR following pelvic reconstructive surgery through a double blind randomized placebo-controlled trial
Detailed Description:
The primary objective is to determine the impact of Tamsulosin on duration of urinary retention following pelvic reconstructive surgery in women Duration of catheterization via indwelling foley or clean intermittent self-catheterization CISC measured in days will be compared between women receiving Tamsulosin versus placebo after diagnosis of postoperative urinary retention via standardized voiding trial It is hypothesized that women receiving Tamsulosin will have a shorter duration of urinary retention fewer urinary tract infections and improved quality of life as compared with placebo The Euroqol-5D EQ-5D will be used to compare physical emotional functional and socialfamily well-being between women receiving Tamsulosin and placebo
Upon diagnosis of POUR women will be offered participation in the study Once consent is obtained women will be randomized to tamsulosin 04 mg or matching placebo capsules to be used daily until resolution of POUR or a 10 day course whichever occurs first
Upon diagnosis of POUR women will be offered participation in the study Once consent is obtained women will be randomized to tamsulosin 04 mg or matching placebo capsules to be used daily until resolution of POUR or a 10 day course whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None