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

NCT03474653 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 399

Last updated 2023-04-14

No results posted yet for this study

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

Sponsors & Collaborators

  • Contura

    collaborator INDUSTRY
  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Fiona M Reid · Manchester University Hospitals NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2018-12-31
Completion
2024-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03474653 on ClinicalTrials.gov