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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Incontinence; 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.

• Study Type: Observational
• Enrollment (Actual): 399

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9WL
    • Manchester University Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women with urodynamic stress incontinence who wish to proceed with further treatment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PGI-S	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.	12 months post Bulkamid

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Bulking MUS rate	The number of women who go to have a MUS	6, 12, 24 and 60 months
Complications post Bulkamid	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).	6, 12, 24 and 60 months
PGI-I; a single question with a 7-item response.	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).	6, 12, 24 and 60 months
PGI-S; a single question with a 4-item response.	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).	6, 12, 24 and 60 months
ICIQ-SF	International Consultation on Incontinence Questionnaire - Short Form ICIQ-SF; a short 4 question	6, 12, 24 and 60 months
Electronic Patient Questionnaire	ePAQ incontinence domains (Pain; Voiding; OAB; SUI; QoL).	6, 12, 24 and 60 months
Pads used due to leakage	Number of women still using pads due to leakage question	6, 12, 24 and 60 months
Pads used due to fear of leakage.	Number of women still using pads due to fear of leakage question	6, 12, 24 and 60 months
EQ-5D	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	6, 12, 24 and 60 months

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: Contura
• Investigators: Principal Investigator: Fiona M Reid, Manchester University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Stress urinary incontinence; Bulkamid; Bulking
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: V1 15/12/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No