Latitude: study of patient choice and effectiveness of Bulkamid®in SUI

• Research type

  Research Study

• Full title

  Latitude: An observational study of patient choice and the use of the urethral bulking agent, Bulkamid®, as a first line treatment for stress urinary incontinence and the effect on a subsequent mid urethral sling

• IRAS ID

  214112

• Contact name

  Fiona Reid

• Contact email

  fiona.reid@cmft.nhs.uk

• Sponsor organisation

  Central Manchester NHS Foundation Trust

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  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 embedded qualitative sub-study to investigate factors that influence patient choice of surgical treatment for SUI.
  
  Bulkamid® is a non-toxic hydrogel that is injected under the lining of the urethra. It increases the urethral ‘bulk’, hence increasing resistance against leakage of urine. It is being increasingly offered as a primary treatment for SUI due to the reduced associated risks, ability to administer in the outpatient setting and recent controversy surrounding polypropylene mesh. However, there is currently limited data on how effective it is as a first line treatment, both in the short and long term, and what effect it may have on secondary continence procedures. This study aims to collect data from 220 women who choose Bulkamid® as their primary treatment over a total of 60 months to review its effectiveness. Telephone consultations will take place at regular intervals using validated questionnaires to assess SUI symptoms.

  It is not known how easy women find it to choose between the surgical treatment options for SUI, what factors they weigh up or what information would help them make this decision. The embedded qualitative study of patient choice will use a combination of questionnaire and 2 in-depth semi structured interviews to investigate this further. Consultant Urogynaecologists will also be interviewed to compare factors they think are important to their patients’ treatment decision with what is expressed by women with SUI. The overall aim is to develop a prototype decision aid to better support women when making this treatment decision.

• REC name

  North West - Greater Manchester West Research Ethics Committee

• REC reference

  17/NW/0155

• Date of REC Opinion

  4 Apr 2017

• REC opinion

  Further Information Favourable Opinion