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Recruiting

NCT Number: NCT06968741

A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)

Prospective, multicenter, single-arm study

Recruiting

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Lille, Lille, France

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Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Male subjects aged ≥ 22 years old
  • Able to read, comprehend and willing to sign an informed consent form
  • Primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator
  • Appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator

Key Exclusion Criteria:

  • Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study (for urinary incontinence) in the past 3 months prior to informed consent
  • Poor candidate for surgical procedures and/or anesthesia, as determined by investigator
  • Currently implanted with an Active Implantable Medical Device (AIMD)
  • Symptoms or diagnosis of urge incontinence or mixed incontinence (MI) with a predominant urgency component, as assessed by the investigator

Treatment and study plan

Artificial Urinary Sphincter (AUS)

Device

AUS implant

Primary outcomes

  1. Responder rate at 26 weeks post-activation

    Time frame: 26 weeks

    Proportion of subjects who report greater than or equal to 50% reduction in the 24 hour Pad Weight Test (PWT) at 26 weeks compared with Baseline

Other outcomes

  1. Proportion of subjects reporting change in overall impression of improvement (PGI-I)

    Time frame: 26 weeks

    Proportion of subjects reporting change in their overall impression of improvement with the use of their treatment as compared with Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Roshini Jain

CONTACT

[email protected]

14697669888

Sponsors and collaborators

Lead sponsor

UroMems SAS

Industry

Registry information

Official study title

Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men

Acronym: SOPHIA2

Important dates

Study start
2025
Primary completion
2026
Study completion
2031
First posted
May 13, 2025
Registry last updated
Mar 27, 2026

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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