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Peri-urethral Bulk Agent Injection of Bulkamid®

Evolution of Symptoms After Peri-urethral Bulk Agent Injection of Bulkamid® for Urinary Incontinence

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05741580
Acronym
BULKIU
Enrollment
70
Registered
2023-02-23
Start date
2022-10-01
Completion date
2022-12-31
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

Bulkamid®, bulk agent, peri-urethral injection, urinary incontinence

Brief summary

There are currently different treatment options in the management of stress urinary incontinence according to the latest recommendations. 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. 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. 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. 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.

Interventions

PROCEDUREEvolution of symptoms

percentage of patients with improvement in their symptoms

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Evolution of symptomsat 7 days after surgerypercentage of patients with improvement in their symptoms on the PGI-I scale (score 1, 2, or 3)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026