Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606613
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Cross-linked Hyaluronic Aciddextranomer for the Treatment of Stress Urinary Incontinence
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Midurethral Sling Versus Cross-linked Hyaluronic Aciddextranomer CLHADx for the Treatment of Stress Urinary Incontinence
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLHADx
Brief Summary:
The investigators aimed to evaluate the effectiveness and safety of intraurethral cross-linked hyaluronic aciddextranomer CLHADx injection for the treatment of stress urinary incontinence SUI in women
Detailed Description:
This single-center prospective pre-post interventional study was conducted between October 2025 and April 2025 with 60 women 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 The need for additional treatment re-injection other surgical approaches etc was recorded
Participants were followed up to 6 months after intervention All outcomes of interest and complications were evaluatedrecorded at three preplanned visits postoperative 1st 3rd 6th months
Participants were followed up to 6 months after intervention All outcomes of interest and complications were evaluatedrecorded at three preplanned visits postoperative 1st 3rd 6th months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None