Ignite Creation Date:
2024-07-17 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480227
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-14
Brief Title:
Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
Sponsor:
NICHD Pelvic Floor Disorders Network
Organization:
NICHD Pelvic Floor Disorders Network
Study Overview
Official Title:
A Randomized Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
Status:
RECRUITING
Status Verified Date:
2024-09
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:
BASIS
Brief Summary:
This is a multicentered double-blind randomized controlled surgical trial of 358 women with inadequate symptom relief of stress urinary incontinence SUI or stress predominant mixed urinary incontinence MUI after conservative care
The Primary Aim is to determine the comparative effectiveness as defined by much or very much improved on PGI-I of transurethral bulking agent TBA for 1 or 2 injections in 12 months vs single-incision sling SIS 12 months after treatment intervention in women with predominant stress urinary incontinence SUI
The Primary Aim is to determine the comparative effectiveness as defined by much or very much improved on PGI-I of transurethral bulking agent TBA for 1 or 2 injections in 12 months vs single-incision sling SIS 12 months after treatment intervention in women with predominant stress urinary incontinence SUI
Detailed Description:
The BASIS trial is a multicentered double-blind randomized controlled surgical trial with two active interventions 1 a transurethral bulking agent TBA or 2 a single-incision sling SIS Both interventions are FDA-approved treatment options for urinary incontinence and will be used in line with their approved use Participants will be randomly assigned to one of the interventions A total of 358 women will be randomized 11 to TBA or SIS
All participants will have data including demographics medical history and quality of life assessments as they relate to urinary incontinence collected at baseline After undergoing treatment either transurethral bulking agent or single-incision sling participants will be asked to return to the clinic at 2-4 weeks 3 months and 12 months with additional follow-ups at 6 months 24 months and 36 months done over the phone
The primary outcome of the BASIS trial is subjective success measured by PGI-I for TBA vs SIS at 12 months
Secondary outcomes include assessments of 1 retreatment rates within 12 months 2 validated objective measures of condition improvement through 36 months 3 objective success at 3 and 12 months as measured by standardized cough stress test 4 functional outcomes activity level perceived recover sexual function etc 5 quality of life assessments 6 operative procedure data and adverse events 7 pain and functional activity need for sedation and anesthesia de novo or worsening symptoms 8 medical resource use additional medications procedures or therapies and 9 healthy utility measures
All participants will have data including demographics medical history and quality of life assessments as they relate to urinary incontinence collected at baseline After undergoing treatment either transurethral bulking agent or single-incision sling participants will be asked to return to the clinic at 2-4 weeks 3 months and 12 months with additional follow-ups at 6 months 24 months and 36 months done over the phone
The primary outcome of the BASIS trial is subjective success measured by PGI-I for TBA vs SIS at 12 months
Secondary outcomes include assessments of 1 retreatment rates within 12 months 2 validated objective measures of condition improvement through 36 months 3 objective success at 3 and 12 months as measured by standardized cough stress test 4 functional outcomes activity level perceived recover sexual function etc 5 quality of life assessments 6 operative procedure data and adverse events 7 pain and functional activity need for sedation and anesthesia de novo or worsening symptoms 8 medical resource use additional medications procedures or therapies and 9 healthy utility measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG1HD069013 | NIH | None | None |
| UG1HD054214 | NIH | None | None |
| UG1HD041267 | NIH | None | None |
| UG1HD054241 | NIH | None | None |
| UG1HD110057 | NIH | None | None |
| UG1HD069010 | NIH | None | None |
| U24HD069031 | NIH | None | None |