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

• ClinicalTrials.gov Identifier: NCT03474653
• Recruitment Status: Active, not recruiting
• First Posted: March 22, 2018
• Last Update Posted: February 24, 2021
• Sponsor: Manchester University NHS Foundation Trust
• Collaborator: Contura
• Information provided by (Responsible Party): Manchester University NHS Foundation Trust

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 399 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Post Bulking MUS rate [ Time Frame: 6, 12, 24 and 60 months ]
   The number of women who go to have a MUS
2. 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).
3. 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).
4. 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).
5. ICIQ-SF [ Time Frame: 6, 12, 24 and 60 months ]
   International Consultation on Incontinence Questionnaire - Short Form ICIQ-SF; a short 4 question
6. Electronic Patient Questionnaire [ Time Frame: 6, 12, 24 and 60 months ]
   ePAQ incontinence domains (Pain; Voiding; OAB; SUI; QoL).
7. Pads used due to leakage [ Time Frame: 6, 12, 24 and 60 months ]
   Number of women still using pads due to leakage question
8. 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
9. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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

Contacts and Locations

Locations

United Kingdom

Manchester University Hospital NHS Foundation Trust

Manchester, United Kingdom, M13 9WL

Sponsors and Collaborators

Manchester University NHS Foundation Trust

Contura

Investigators

• Principal Investigator: Fiona M Reid; Manchester University Hospitals NHS Foundation Trust

More Information

• Responsible Party: Manchester University NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT03474653
• Other Study ID Numbers: V1 15/12/16
• First Posted: March 22, 2018
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Data will not be shared with other researchers.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manchester University NHS Foundation Trust:

Stress urinary incontinence; Bulking; Bulkamid

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders