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New gel injection offers hope for urinary incontinence without surgery

NCT ID NCT05741580

Symptom relief Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well a gel called Bulkamid works for stress urinary incontinence in women. The gel is injected around the urethra to help the bladder control urine flow. Researchers tracked symptom improvement in 70 women who received the injection. The goal was to see how many felt better after the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bulkamid (a gel injected around the urethra)
What this could lead to
If successful, this could confirm Bulkamid as a safe, less invasive option for women with stress urinary incontinence who want to avoid surgery.
What could go wrong
This is a small, completed study with no control group, so results may not apply broadly. The treatment aims for improvement, not a cure, and some women may see little benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

70 people

The number who actually took part.

Started

Oct 2022

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study concerns all patients who received a first peri-uthral injection of Bulkamid® in the context of urinary incontinence between September 2020 and November 2022.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* Inclusion Criteria : * women over 18 * patients who received a first peri-urethral injection of Bulkamid® in the context of urinary incontinence * intervention between September 2020 and November 2022 * person having expressed his non-opposition * Exclusion Criteria : * inability to understand the information given * person deprived of liberty * person under guardianship

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Conditions

The condition(s) this trial relates to.

female stress incontinence Urinary Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urinary incontinence

Contacts and locations

Locations

  • Service de Gynécologie, HFME, Hospices Civils de Lyon

    Bron, 69500, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.