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COMPLETED
NCT07900906

Perineal Ultrasound After Bulkamid® Injection for Urinary Incontinence

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Benefit of Perineal Ultrasound After Injection of Bulkamid® Peri-urethral Filler for Urinary Incontinence

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2026-01-01

Completion Date

2026-04-01

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

OTHER

Improvement in patients' symptoms

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

Locations (1)

Hôpital Femme Mère Enfant

Lyon, France