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

NCT03474653 | Unknown

• 1 other identifier: V1 15/12/16
• Study Type: observational
• Target: 399
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Stress Urinary Incontinence

Keywords

Stress urinary incontinence; Bulking; Bulkamid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Post Bulking MUS rate

  6, 12, 24 and 60 months

• Complications post Bulkamid

  6, 12, 24 and 60 months

• PGI-I; a single question with a 7-item response.

  6, 12, 24 and 60 months

• PGI-S; a single question with a 4-item response.

  6, 12, 24 and 60 months

• ICIQ-SF

  6, 12, 24 and 60 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All women with urodynamic stress incontinence that are eligible for surgery for SUI.
• Evidence of previous supervised pelvic floor muscle training

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Contura: collaborator

Study Sites (1)

Manchester University Hospital NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fiona M Reid

  Manchester University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 22, 2018
• Study Start: June 12, 2017
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2024
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)