Status:
UNKNOWN
LATITUDE An Observational Study of Patient Choice and the Urethral Bulking Agent, Bulkamid®
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
Contura
Conditions:
Urinary Incontinence
Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Brief Summary
Latitude is an observational study exploring how effective Bulkamid ® is as a first line treatment for women with stress urinary incontinence. Women who choose to have Bulkamid as part of their standa...
Detailed Description
This is a multi-centre observational study to investigate the effectiveness of the urethral bulking agent, Bulkamid®, as a primary treatment for stress urinary incontinence (SUI). It also contains an ...
Eligibility Criteria
Inclusion
- All women with urodynamic stress incontinence that are eligible for surgery for SUI.
- Evidence of previous supervised pelvic floor muscle training
Exclusion
- OAB (overactive bladder) predominant mixed incontinence
- Any previous surgery for urinary incontinence
- Concomitant prolapse surgery
- Detrusor over activity on urodynamics
- Residual urine \> 100ml at urodynamics
- Bladder capacity \< 300 ml
- An acute urinary tract infection (UTI)
- An allergic reaction to the local anaesthesia used in the treating unit
- An allergic reaction to all the antibiotics which could be used for prophylaxis
- Current treatment with systemic corticosteroids
- Pregnancy
- Active autoimmune or connective tissue diseases
- Not fluent in English requiring an independent interpreter
Key Trial Info
Start Date :
June 12 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT03474653
Start Date
June 12 2017
End Date
June 30 2024
Last Update
April 14 2023
Active Locations (1)
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1
Manchester University Hospital NHS Foundation Trust
Manchester, United Kingdom, M13 9WL