Peri-urethral Bulk Agent Injection of Bulkamid®

NCT05741580 | Completed

• 2 other identifiers: 22-509369HCL22_1157
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Evolution of symptoms

  percentage of patients with improvement in their symptoms on the PGI-I scale (score 1, 2, or 3)

  at 7 days after surgery

Study Arms (1)

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

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

Procedure: Evolution of symptoms

Interventions

Evolution of symptoms PROCEDURE

percentage of patients with improvement in their symptoms

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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study concerns all patients who received a first peri-uthral injection of Bulkamid® in the context of urinary incontinence between September 2020 and November 2022.

You may qualify if:

• 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

You may not qualify if:

• inability to understand the information given
• person deprived of liberty
• person under guardianship

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Gynécologie, HFME, Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: October 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)