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COMPLETED
NCT07900880

Quantity of Bulkamid® After Injection for Urinary Incontinence

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2026-01-01

Completion Date

2026-03-01

Last Updated

2026-10-28

Healthy Volunteers

No

Locations (1)

Hôpital Femme Mère Enfant

Lyon, France