At-home electrical stimulation treatment for stress urinary incontinence in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, sham-controlled multicenter trial enrolling women with stress urinary incontinence. Participants are assigned to either a non-implantable neuromuscular electrical stimulation device or a sham device and self-administer treatment at home twice daily for 15 minutes, at least five days per week, for 12 weeks. The primary outcome is the proportion of patients whose leakage falls below 1 g on the standardized pad test at Week 12. Patients with predominant urgency or overflow incontinence are excluded and must complete baseline and follow-up visits at the study site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with urine leakage of ≥1 g on the standardized pad test

Exclusion Criteria:

* Patients with mixed urinary incontinence with predominant urgency urinary incontinence
* Patients with stress urinary incontinence
* Patients with overflow urinary incontinence

Where it's running

• Samsung Seoul Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Kyu Sung Lee, MD — Samsung Seoul Hospital
• Study coordinator: Myeongbae Shin, Researcher
• Email: mbshin94@ceragem.com
• Phone: 82-10-4373-2808

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Pubo-urethral ligament plication versus transobturator tape for female stress urinary incontinence

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.