LATITUDE An Observational Study of Patient Choice and the Urethral Bulking Agent, Bulkamid®
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|ClinicalTrials.gov Identifier: NCT03474653|
Recruitment Status : Active, not recruiting
First Posted : March 22, 2018
Last Update Posted : February 21, 2020
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.
|Condition or disease|
|Urinary Incontinence Stress Urinary Incontinence|
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.
|Study Type :||Observational|
|Actual Enrollment :||399 participants|
|Official Title:||Latitude-An Observational Study of Patient Choice and the Urethral Bulking Agent, Bulkamid®, Used for the First Line Treatment for Stress Urinary Incontinence and the Impact on a Subsequent Mid Urethral Sling|
|Actual Study Start Date :||June 14, 2017|
|Actual Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||June 30, 2023|
Latitude 1 (Bulking)
Women with first line stress incontinence who choose to have Bulkamid as a treatment
Latitude 2 (Choice)
Women with first line stress incontinence who choose to have any treatment including Bulking.
- PGI-S [ Time Frame: 12 months post Bulkamid ]The primary outcome will be the score of PGI-S of patients 12 months after Bulkamid® or the last PGI-S recorded for those who have gone on to have a second injection of Bulkamid® or MUS.
- Post Bulking MUS rate [ Time Frame: 6, 12, 24 and 60 months ]The number of women who go to have a MUS
- Complications post Bulkamid [ Time Frame: 6, 12, 24 and 60 months ]Number of women who started taking drugs for OAB after surgery Number of women with recurrent UTI (defined as 2 UTIs in 6 months); Number of women performing clean intermittent self-catheterisation (CISC).
- PGI-I; a single question with a 7-item response. [ Time Frame: 6, 12, 24 and 60 months ]Patient Global Impressions of Improvement validated questionnaire Number of women with recurrent UTI (defined as 2 UTIs in 6 months); Number of women performing clean intermittent self-catheterisation (CISC).
- PGI-S; a single question with a 4-item response. [ Time Frame: 6, 12, 24 and 60 months ]Patient Global Impressions of Severity validated questionnaire Number of women with recurrent UTI (defined as 2 UTIs in 6 months); Number of women performing clean intermittent self-catheterisation (CISC).
- ICIQ-SF [ Time Frame: 6, 12, 24 and 60 months ]International Consultation on Incontinence Questionnaire - Short Form ICIQ-SF; a short 4 question
- Electronic Patient Questionnaire [ Time Frame: 6, 12, 24 and 60 months ]ePAQ incontinence domains (Pain; Voiding; OAB; SUI; QoL).
- Pads used due to leakage [ Time Frame: 6, 12, 24 and 60 months ]Number of women still using pads due to leakage question
- Pads used due to fear of leakage. [ Time Frame: 6, 12, 24 and 60 months ]Number of women still using pads due to fear of leakage question
- EQ-5D [ Time Frame: 6, 12, 24 and 60 months ]EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474653
|Manchester University Hospital NHS Foundation Trust|
|Manchester, United Kingdom, M13 9WL|
|Principal Investigator:||Fiona M Reid||Manchester University Hospitals NHS Foundation Trust|