Peri-urethral Bulk Agent Injection of Bulkamid®

Completed

• Conditions: Peri-urethral Bulk Agent Injection of Bulkamid® for Urinary Incontinence
• Interventions: Procedure: Evolution of symptoms

• Registration Number: NCT05741580
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

There are currently different treatment options in the management of stress urinary incontinence according to the latest recommendations \[1\]. Suburethral slings are currently considered the first surgical option due to an excellent cure rate of around 90%. Nevertheless, due to a risk of prosthetic complications and numerous current controversies over the placement of synthetic tissue, other therapeutic alternatives must be offered to patients \[2\].

Peri-urethral bulk agent injections have been used since 2006 in urinary incontinence and should be integrated into the therapeutic arsenal. This is a minimally invasive technique performed under local anesthesia on an outpatient basis. The mechanism of action is explained by better coaptation of the urethra and increased resistance to urine flow during the bladder filling phase. It also increases the strength of the striated sphincter thanks to a better arrangement of muscle fibers \[3\].

According to the European Association of Urology (EAU), the use of bulk agents is recommended for the management of urinary incontinence in elderly and/or frail patients whose comorbidities contraindicate surgical management. These peri-urethral injections can also be offered to patients with incontinence due to sphincter deficiency but also to young women with stress urinary incontinence who are ready to accept a partial improvement in their incontinence \[1\]. The personal choice of the patient is currently a decisive factor for the implementation of a treatment for functional disorders and in particular for urinary incontinence.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Last Update Submitted: 2023-02-14
• Study First Posted: 2023-02-23
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
peri-urethral bulk agent injection of Bulkamid® for urinary incontinence	Evolution of symptoms	patients who received a first injection of Bulkamid® in the context of urinary incontinence

Primary Outcome Measures

Name	Time	Method
Evolution of symptoms	at 7 days after surgery	percentage of patients with improvement in their symptoms on the PGI-I scale (score 1, 2, or 3)

Trial Locations

Locations (1)

Service de Gynécologie, HFME, Hospices Civils de Lyon; 🇫🇷 Bron, France