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CompletedNCT07900880BULKA3DUpdated Oct 28, 2026

Quantity of Bulkamid® After Injection for Urinary Incontinence

An observational study in Bulkamid® for Urinary Incontinence, Urinary Incontinence and Ultrasound, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Hospices Civils de Lyon · Observational

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
40
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Bulkamid® for Urinary Incontinence
  • Urinary Incontinence
  • Ultrasound

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Keywords

  • Bulkamid®
  • urinary incontinence
  • ultrasound
03

In context

Urinary Incontinence

983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.

This study's enrollment of 40 is below the median of 120 across 215 observational studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

  • inability to understand the information given

    • person deprived of liberty
    • person under guardianship
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Bulkamid

    patients who received an injection of Bulkamid® for urinary incontinence

06

What researchers measure

Primary outcomes

  1. volume of Bulkamid

    Time frame: 3 months after injection

07

Study locations

1 site
  • Hôpital Femme Mère Enfant
    Lyon, 69500, France
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2026 to primary completion in Feb 2026, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Oct 28, 2026
StartActual
Jan 1, 2026
Primary completionActual
Feb 1, 2026
CompletionActual
Mar 1, 2026
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07900880
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Jan 1, 2026
Primary completion
Feb 1, 2026
Completion
Mar 1, 2026
Last update
Oct 28, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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