Clinical trial NCT03474653: LATITUDE An Observational Study of Patient Choice and the Urethral Bulking Agent, Bulkamid®
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Incontinence
Stress Urinary Incontinence
Keywords: Stress urinary incontinence
Bulking
Bulkamid
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Contura
First posted: 2018-03-22
Enrollment: 399
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with urodynamic stress incontinence who wish to proceed with further treatment

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: PGI-S
timeFrame: 12 months post Bulkamid
Secondary outcomes:
measure: Post Bulking MUS rate
timeFrame: 6, 12, 24 and 60 months
measure: Complications post Bulkamid
timeFrame: 6, 12, 24 and 60 months
measure: PGI-I; a single question with a 7-item response.
timeFrame: 6, 12, 24 and 60 months
measure: PGI-S; a single question with a 4-item response.
timeFrame: 6, 12, 24 and 60 months
measure: ICIQ-SF
timeFrame: 6, 12, 24 and 60 months
measure: Electronic Patient Questionnaire
timeFrame: 6, 12, 24 and 60 months
measure: Pads used due to leakage
timeFrame: 6, 12, 24 and 60 months
measure: Pads used due to fear of leakage.
timeFrame: 6, 12, 24 and 60 months
measure: EQ-5D
timeFrame: 6, 12, 24 and 60 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University Hospital NHS Foundation Trust
Study officials:
affiliation: Manchester University Hospitals NHS Foundation Trust
name: Fiona M Reid
role: PRINCIPAL_INVESTIGATOR
References: