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CompletedNCT07900906BULKPOSUpdated Oct 28, 2026

Perineal Ultrasound After Bulkamid® 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
70
Ages
18 Years and older
Sex
Female
01

Study summary

There are currently different treatment options in the management of stress urinary incontinence (SUI). Given a risk of complications inherent to prosthetic reinforcement and numerous current controversies over the use of a synthetic material, other alternatives must be offered to patients. Peri-urethral injections of filler are increasingly becoming part of the therapeutic arsenal. This is a minimally invasive technique carried out under local anesthesia on an outpatient basis.

Peri-urethral injections are currently offered to all patients with stress urinary incontinence, due to sphincter or mixed insufficiency and particularly after suburethral sling failure.

Perineal ultrasound after injection allows you to visualize the positioning of the filler bubbles under the bladder neck. In the event of clinical ineffectiveness associated with poor position of the bubbles, this could be an argument for a 2nd injection. If, on the contrary, the bubbles are well positioned, another technique could be proposed.

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 70 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 a first 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 a first 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
70 participants (actual)
Patient registry
No

Groups and cohorts

  • Bulkamid

    Patients who received a first injection of Bulkamid® for urinary incontinence

    Other: Improvement in patients' symptoms

Interventions

  • OtherImprovement in patients' symptoms

    Improvement in patients' symptoms on the PGI-I scale (score 1, 2 or 3) at 7 days after the intervention

06

What researchers measure

Primary outcomes

  1. improvement in patients' symptoms

    improvement in patients' symptoms on the PGI-I scale (score 1, 2, or 3) at 7 days after the intervention

    Time frame: 7 days after the intervention

07

Study locations

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

Updates

1 registry update since Sep 25, 2026
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
NCT07900906
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Jan 1, 2026
Primary completion
Feb 28, 2026
Completion
Apr 1, 2026
Last update
Oct 28, 2026
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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