Urinary IncontinenceNCT03474653
LATITUDE An Observational Study of Patient Choice and the Urethral Bulking Agent, Bulkamid®
An observational study of Urinary Incontinence and Stress Urinary Incontinence, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress Urinary Incontinence
- How many people
- 399 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2017to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with urodynamic stress incontinence who wish to proceed with further treatment
Who may be able to join
- All women with urodynamic stress incontinence that are eligible for surgery for SUI.
- Evidence of previous supervised pelvic floor muscle training
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University Hospital NHS Foundation Trust
Manchester, M13 9WL
About this study
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
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.
Read the 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.
- Conditions
- Urinary Incontinence, Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence, Bulking, Bulkamid
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post Bulkamid
Secondary outcomes (9)
Post Bulking MUS rate
The number of women who go to have a MUS
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6, 12, 24 and 60 months
ICIQ-SF
International Consultation on Incontinence Questionnaire - Short Form ICIQ-SF; a short 4 question
Measured: 6, 12, 24 and 60 months
Electronic Patient Questionnaire
ePAQ incontinence domains (Pain; Voiding; OAB; SUI; QoL).
Measured: 6, 12, 24 and 60 months
Pads used due to leakage
Number of women still using pads due to leakage question
Measured: 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
Measured: 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
Measured: 6, 12, 24 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start12 Jun 2017
- Primary completion31 Dec 2018
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Contura
- Responsible party
- Sponsor
- Investigators
- Fiona M Reid, Principal investigator, Manchester University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474653
- Sponsor's protocol ID
- V1 15/12/16
- Status last verified
- Apr 2023
- First submitted
- 15 Mar 2018
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03474653
- Acronym / sponsor ID
- V1 15/12/16
- Conditions
- Urinary Incontinence, Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence, Bulking, Bulkamid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Contura
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with urodynamic stress incontinence who wish to proceed with further treatment
Key inclusion criteria (2 listed)
- All women with urodynamic stress incontinence that are eligible for surgery for SUI.
- Evidence of previous supervised pelvic floor muscle training
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
Post Bulking MUS rate
Time frame: 6, 12, 24 and 60 months
Complications post Bulkamid
Time frame: 6, 12, 24 and 60 months
PGI-I; a single question with a 7-item response.
Time frame: 6, 12, 24 and 60 months
PGI-S; a single question with a 4-item response.
Time frame: 6, 12, 24 and 60 months
ICIQ-SF
Time frame: 6, 12, 24 and 60 months
Electronic Patient Questionnaire
Time frame: 6, 12, 24 and 60 months
Pads used due to leakage
Time frame: 6, 12, 24 and 60 months
Pads used due to fear of leakage.
Time frame: 6, 12, 24 and 60 months
EQ-5D
Time frame: 6, 12, 24 and 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No. Data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona M Reid principal investigator
Manchester University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Stress Urinary Incontinence, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PGI-S (time frame: 12 months post Bulkamid). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.