Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04812574
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2021-02-04
Brief Title:
Hypertonic Saline Injection For Urinary Incontinence
Sponsor:
Turgut Ozal University
Organization:
Turgut Ozal University
Study Overview
Official Title:
Periurethral Hypertonic Saline 10 Injection for Female Stress Urinary Incontinence and Stress-Predominant Mixed Urinary Incontinence
Status:
COMPLETED
Status Verified Date:
2021-03
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 investigators aimed to evaluate the effectiveness and safety of periurethral hypertonic saline 10 NaCl injection for the treatment of stress urinary incontinence SUI and stress-predominant mixed urinary incontinence MUI in women
Detailed Description:
This single-center prospective pre-post interventional study was conducted between January 2014 and April 2018 with 65 women 44 SUI 21 MUI Quality of life was evaluated with the Incontinence Quality of Life Scale I-QoL and the lower urinary tract symptoms of women were evaluated with the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules ICIQ-FLUTS Incontinence status was assessed via the Stamey Incontinence Grade scale Patients with MUI also were evaluated using the Urinary Distress Inventory-6 UDI-6 The need for additional treatment re-injection other surgical approaches etc was recorded
Participants were followed up to 24 months after intervention All outcomes of interest and complications were evaluatedrecorded at six preplanned visits postoperative 1st 3rd 6th 12th 18th 24th months
Participants were followed up to 24 months after intervention All outcomes of interest and complications were evaluatedrecorded at six preplanned visits postoperative 1st 3rd 6th 12th 18th 24th months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None