Skip to main content
OpenTrials
Completed

NCT Number: NCT00333073

Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence

To assess effectiveness of Bulkamid® injection in females suffering from stress or mixed (stress and urge) urinary incontinence after 12 months follow up period

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Skejby Sygehus, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent
  • Symptomatic stress or mixed urinary incontinence for at least 12 months
  • Having at least 1 incontinence episode per day over three days

Exclusion criteria

  • Regular or intermittent users of an urethral catheter
  • Pregnant women
  • Suffer from severe allergies or anaphylaxis
  • Suffer from autoimmune diseases or any unstable or sever cardio-vascular disease
  • History of any cancer within the last 5 years
  • Previous surgery for the treatment of urinary incontinence, including bulking

Treatment and study plan

Bulkamid

Device

initial injection with option for second (if required)

Primary outcomes

  1. Subjective responder rate after 12 months follow-up

    Time frame: 12 months

Secondary outcomes

  1. ICIQ

    Time frame: Baseline, treatment, 1-, 6-, 12- and 24-months

  2. 24 hour urine leakage

    Time frame: Baseline, treatment, 1-, 6-, 12- and 24-months

  3. daily incidence of incontinence episodes

    Time frame: Baseline, treatment, 1-, 6-, 12- and 24-months

  4. Qol

    Time frame: Baseline, treatment, 1-, 6-, 12- and 24-months

Sponsors and collaborators

Lead sponsor

Contura

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Jun 2, 2006
Registry last updated
Feb 17, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.