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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03474653
Recruitment Status : Active, not recruiting
First Posted : March 22, 2018
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
Contura
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

Tracking Information
First Submitted Date March 15, 2018
First Posted Date March 22, 2018
Last Update Posted Date February 21, 2020
Actual Study Start Date June 14, 2017
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 21, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 21, 2018)
  • Post Bulking MUS rate [ Time Frame: 6, 12, 24 and 60 months ]
    The number of women who go to have a MUS
  • 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).
  • 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).
  • 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).
  • ICIQ-SF [ Time Frame: 6, 12, 24 and 60 months ]
    International Consultation on Incontinence Questionnaire - Short Form ICIQ-SF; a short 4 question
  • Electronic Patient Questionnaire [ Time Frame: 6, 12, 24 and 60 months ]
    ePAQ incontinence domains (Pain; Voiding; OAB; SUI; QoL).
  • Pads used due to leakage [ Time Frame: 6, 12, 24 and 60 months ]
    Number of women still using pads due to leakage question
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title LATITUDE An Observational Study of Patient Choice and the Urethral Bulking Agent, Bulkamid®
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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women with urodynamic stress incontinence who wish to proceed with further treatment
Condition
  • Urinary Incontinence
  • Stress Urinary Incontinence
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: February 20, 2020)
399
Original Estimated Enrollment
 (submitted: March 21, 2018)
880
Estimated Study Completion Date June 30, 2023
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03474653
Other Study ID Numbers V1 15/12/16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Data will not be shared with other researchers.
Responsible Party Manchester University NHS Foundation Trust
Study Sponsor Manchester University NHS Foundation Trust
Collaborators Contura
Investigators
Principal Investigator: Fiona M Reid Manchester University Hospitals NHS Foundation Trust
PRS Account Manchester University NHS Foundation Trust
Verification Date February 2020