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OpenTrials
Completed

NCT Number: NCT05741580

Peri-urethral Bulk Agent Injection of Bulkamid®

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Evolution of symptoms

Procedure

percentage of patients with improvement in their symptoms

Primary outcomes

  1. Evolution of symptoms

    Time frame: at 7 days after surgery

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: BULKIU

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2023
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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