Urinary Stress IncontinenceNCT00984958
Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure
A study testing Bulkamid and Bulkamid expectation in people with Urinary Stress Incontinence and Treatment, run by Skaraborg Hospital at 1 site in Sweden.
Trial summary
The aim of this prospective, randomized study of Bulkamid treatment is to investigate the efficacy of Bulkamid treatment in women with urinary stress incontinence not suitable to TVT-procedure because of suspected ISD. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Urinary Stress Incontinence, Treatment
- What is being tested?
- Bulkamid and Bulkamid expectation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2009to Dec 2016
- Phase
- Interventional
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand the information and to give informed consent.
- At least 50 years of age
- History of urinary leakage during low grade physical activity. A woman with genuine stress incontinence has urinary incontinence during running or jumping. Women with suspected ISD have incontinence at much lower grade of physical activity such as slow walking or standing up and just coughing. Walking, standing up from a chair, and coughing are regarded as low grade of physical activity.
- A positive pad-test (after coughing 10 times) with increase of minimum of 10 grams of urine with 300 ml in the bladder or a 24 h pad-test of more than 100 mg of urine
- No hypermobility of the urethra during cough test.
- Low pressure of the urethra (optional?)
- With a of average miction volume of minimum 150 ml and at least one volume of more than 250
Who cannot join
- Women with hypermobility of the urethra during coughing and positive Bonney's test
- Women suitable for a TVT procedure.
- Positive urinary culture
- Urge incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure Because of Suspected ISD: A Prospective Randomized Study
The aim of this prospective, randomized study of Bulkamid treatment is to investigate the efficacy of Bulkamid treatment in women with urinary stress incontinence not suitable to TVT-procedure because of suspected ISD.
Read the detailed description
The aim of this prospective, randomized study is to investigate the effect of Bulkamid injection for women with urinary stress incontinence and not suitable to TVT-procedure because of suspected ISD and compare this treatment with no or traditional treatment. The primary endpoint for efficacy will be reduction of leakage during pad-test at 2 months compared with pad- test before injection.
Secondary endpoints will be patient satisfaction measured at both 2 and 12 months using a questionnaire and the number of side effects.
- Conditions
- Urinary Stress Incontinence, Treatment
- Being tested
- Bulkamid, Bulkamid expectation
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BulkamidDevice
injection of Bulkamid in the urethra
Bulkamid expectationDevice
Also called after 2 month the patient can be treated
expectance
| Study group | Role | What they receive |
|---|---|---|
| Bulkamid | Other | Injection with Bulkamid Receives: Device: Bulkamid |
| expectance | Other | The expectance arm will after 2 month have the same treatment as the treatment arm Receives: Device: Bulkamid expectation |
What is being measured
The primary outcome is the main question the study is designed to answer.
After 2 months a scheduled visit with a new pad-test will be performed and the questionnaires UDI-6 (lover urinary tract symptoms) and IIQ-7 (quality of life) will be filled in.
less intcontines
Measured: 2 month
Secondary outcomes (1)
After 12 months a scheduled visit with new pad-test will be performed and the questionnaires UDI-6 (lover urinary tract symptoms) and IIQ-7 (quality of life) will be filled in.
less inkontinens
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Stress 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1 will get treatment and Group 2 will have no treatment for 2 month
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skaraborg Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Per-Goran Larsson, Skaraborg Hospital
- Investigators
- P-G Larsson, professor, Principal investigator, Departm Ob/Gyn Kärnsjukhuset, 541 85 SKövde, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984958
- Sponsor's protocol ID
- Bulkamid ISD2009 04
- Status last verified
- Aug 2019
- First submitted
- 24 Sep 2009
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure Because of Suspected ISD: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00984958
- Acronym / sponsor ID
- Bulkamid ISD2009 04
- Conditions
- Urinary Stress Incontinence, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Skaraborg HospitalOther government
- Study start
- Oct 2009 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Sep 2009 (estimated)
- 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.
The aim of this prospective, randomized study of Bulkamid treatment is to investigate the efficacy of Bulkamid treatment in women with urinary stress incontinence not suitable to TVT-procedure because of suspected ISD.
Detailed description
The aim of this prospective, randomized study is to investigate the effect of Bulkamid injection for women with urinary stress incontinence and not suitable to TVT-procedure because of suspected ISD and compare this treatment with no or traditional treatment. The primary endpoint for efficacy will be reduction of leakage during pad-test at 2 months compared with pad- test before injection.
Secondary endpoints will be patient satisfaction measured at both 2 and 12 months using a questionnaire and the number of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1 will get treatment and Group 2 will have no treatment for 2 month
| Arm | Type | Receives |
|---|---|---|
| Bulkamid | Other | Device: BulkamidInjection with Bulkamid |
| expectance | Other | Device: Bulkamid expectationThe expectance arm will after 2 month have the same treatment as the treatment arm |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to understand the information and to give informed consent.
- At least 50 years of age
- History of urinary leakage during low grade physical activity. A woman with genuine stress incontinence has urinary incontinence during running or jumping. Women with suspected ISD have incontinence at much lower grade of physical activity such as slow walking or standing up and just coughing. Walking, standing up from a chair, and coughing are regarded as low grade of physical activity.
- A positive pad-test (after coughing 10 times) with increase of minimum of 10 grams of urine with 300 ml in the bladder or a 24 h pad-test of more than 100 mg of urine
- No hypermobility of the urethra during cough test.
Key exclusion criteria (4 listed)
- Women with hypermobility of the urethra during coughing and positive Bonney's test
- Women suitable for a TVT procedure.
- Positive urinary culture
- Urge incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bulkamidinjection of Bulkamid in the urethra | Device | Bulkamid |
| Bulkamid expectationAlso: after 2 month the patient can be treatedexpectance | Device | expectance |
Primary outcome
After 2 months a scheduled visit with a new pad-test will be performed and the questionnaires UDI-6 (lover urinary tract symptoms) and IIQ-7 (quality of life) will be filled in.
Time frame: 2 month
less intcontines
1 secondary outcome
After 12 months a scheduled visit with new pad-test will be performed and the questionnaires UDI-6 (lover urinary tract symptoms) and IIQ-7 (quality of life) will be filled in.
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
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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.
P-G Larsson, professor principal investigator
Departm Ob/Gyn Kärnsjukhuset, 541 85 SKövde, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bulkamid and Bulkamid expectation in people with Urinary Stress Incontinence and Treatment, run by Skaraborg Hospital at 1 site in Sweden.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 30 Aug 2019. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
After 2 months a scheduled visit with a new pad-test will be performed and the questionnaires UDI-6 (lover urinary tract symptoms) and IIQ-7 (quality of life) will be filled in. (time frame: 2 month). 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 30 Aug 2019.