Bulkamid® for Urinary IncontinenceBULKA3DNCT07900880
Quantity of Bulkamid® After Injection for Urinary Incontinence
An observational study of Bulkamid® for Urinary Incontinence and Urinary Incontinence, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Bulkamid filler is a gel that we use very regularly to treat female urinary leakage during exercise. It is a minimally invasive technique which is increasingly used around the world because it has almost no adverse effects compared to suburethral slings. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bulkamid® for Urinary Incontinence, Urinary Incontinence, Ultrasound
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2026to 1 Mar 2026
- 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: This study covers all patients who received an injection of Bulkamid® peri-urethral filler for urinary incontinence between January 2024 and December 2025.
Who may be able to join
- women over 18
- patient who received an injection of peri-urethral filler Bulkamid® for urinary incontinence
- treatment between January 2024 and December 2025
- person having expressed his non-opposition
Who cannot join
- inability to understand the information given
- person deprived of liberty
- person under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Evaluation of the Quantity of Bulkamid® Peri-urethral Filler After Injection for Urinary Incontinence
Bulkamid filler is a gel that we use very regularly to treat female urinary leakage during exercise. It is a minimally invasive technique which is increasingly used around the world because it has almost no adverse effects compared to suburethral slings. The product is injected pre-urethrally and under local anesthesia. The results in terms of improvement are around 70% without knowing why certain patients are improved, slightly improved or not improved at all. One of the hypotheses is that a proportion of the product could be eliminated, and thus the mechanical effect would be reduced. Perineal ultrasound performed in routine practice allows the quantity of gel to be measured in 3 dimensions immediately post-operatively and at 3 months. The objective of this study is to compare the volume of gel between the immediate post-operative and 3 months and to correlate it with clinical results of improvement.
- Keywords
- Bulkamid®, urinary incontinence, ultrasound
- Medical subject headings
- Urinary Incontinence
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 |
|---|---|---|
| Bulkamid | patients who received an injection of Bulkamid® for urinary incontinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of Bulkamid
Measured: 3 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Jan 2026
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulkamid® for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900880
- Sponsor's protocol ID
- 25-5355
- Acronym
- BULKA3D
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of the Quantity of Bulkamid® Peri-urethral Filler After Injection for Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07900880
- Acronym / sponsor ID
- BULKA3D / 25-5355
- Keywords
- Bulkamid®, urinary incontinence, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 28 Oct 2026 (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.
Bulkamid filler is a gel that we use very regularly to treat female urinary leakage during exercise. It is a minimally invasive technique which is increasingly used around the world because it has almost no adverse effects compared to suburethral slings. The product is injected pre-urethrally and under local anesthesia. The results in terms of improvement are around 70% without knowing why certain patients are improved, slightly improved or not improved at all. One of the hypotheses is that a proportion of the product could be eliminated, and thus the mechanical effect would be reduced. Perineal ultrasound performed in routine practice allows the quantity of gel to be measured in 3 dimensions immediately post-operatively and at 3 months. The objective of this study is to compare the volume of gel between the immediate post-operative and 3 months and to correlate it with clinical results of improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bulkamid | – | –patients who received an injection of Bulkamid® for urinary incontinence |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study covers all patients who received an injection of Bulkamid® peri-urethral filler for urinary incontinence between January 2024 and December 2025.
Key inclusion criteria (4 listed)
Key exclusion criteria (3 listed)
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
volume of Bulkamid
Time frame: 3 months after injection
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 28 Oct 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bulkamid® for Urinary Incontinence and Urinary Incontinence, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 3 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 28 Oct 2026. 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 France. 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?
volume of Bulkamid (time frame: 3 months after injection). 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 28 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.