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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

V1 15/12/16

Status

Active, not recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

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 standard clinical care will be asked to complete questionnaires before and after their surgery so that we can assess how their urinary symptoms change. As a second part of the study, we are asking all patients having any first line treatment for stress incontinence to complete a short questionnaire telling us how they decided what treatment to have. A small number of these women will be contacted via telephone and asked whether they would mind being interviewed to tell us more about this. We will also interview a number of doctors taking part in Latitude to find out how they counsel patients about different treatment options for stress urinary incontinence.

What are the participation requirements?

Yes

Inclusion Criteria

- All women with urodynamic stress incontinence that are eligible for surgery for SUI.

- Evidence of previous supervised pelvic floor muscle training

No

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