Peri-urethral Bulk Agent Injection of Bulkamid® (BULKIU)

Civil Hospices of Lyon

Status: Completed

Conditions: Peri-urethral Bulk Agent Injection of Bulkamid® for Urinary Incontinence

Treatments: Procedure: Evolution of symptoms

Study type: Observational

Funder types: Other

Identifiers

NCT05741580

69HCL22_1157 (Other Identifier)

22-5093

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

70 participants in 1 patient group

peri-urethral bulk agent injection of Bulkamid® for urinary incontinence

Description:

patients who received a first injection of Bulkamid® in the context of urinary incontinence

Treatment:

Procedure: Evolution of symptoms