LATITUDE An Observational Study of Patient Choice and the Urethral Bulking Agent, Bulkamid®

NCT ID: NCT03474653

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 399 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-12
• Study Completion Date: 2024-06-30

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.

Conditions

Urinary Incontinence; Stress Urinary Incontinence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Latitude 1 (Bulking)

Women with first line stress incontinence who choose to have Bulkamid as a treatment

No interventions assigned to this group

Latitude 2 (Choice)

Women with first line stress incontinence who choose to have any treatment including Bulking.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Contura

INDUSTRY

Sponsor Role: collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fiona M Reid

Role: PRINCIPAL_INVESTIGATOR

Manchester University Hospitals NHS Foundation Trust

Locations

Manchester University Hospital NHS Foundation Trust

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

V1 15/12/16

Identifier Type: -

Identifier Source: org_study_id