LATITUDE An Observational Study of Patient Choice and the Urethral Bulking Agent, Bulkamid®
Sponsored by Manchester University NHS Foundation Trust
About this trial
Last updated 2 years ago
Study ID
Status
Type
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- All women with urodynamic stress incontinence that are eligible for surgery for SUI.
- Evidence of previous supervised pelvic floor muscle training
Exclusion Criteria
- 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