Safety and Performance study of the C-Life Investigational Electrode for subject-controlled, on-demand, dorsal genital nerve stimulation to treat urgency urinary incontinence.

Safety and Performance study of the C-Life Investigational Electrode for subject-controlled, on-demand, dorsal genital nerve stimulation to treat urgency urinary incontinence. - Safety and Performance study of the C-Life Investigational Electrode

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42806

Enrollment

Registered

2015-09-21

Start date

2016-03-29

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

urgency urinairy incontinence

Interventions

Patients will complete voiding diaries and a padtest for 3 days prior to the date of investigation. Patients will also complete an Urgency Severity Score sheet. The C-Life Investigational Electrode

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: urgency urinairy incontinence

Exclusion criteria

Exclusion criteria: neurological disease that cause the urgency urinairy incontinence

Design outcomes

Primary

Measure	Time frame
Safety and performance of the C-life Investigational Electrode.	—

Secondary

Measure	Time frame
Secondary outcomes: Decrease in number or severity of incontinence episodes per 24 h >50% of baseline status. To record the electrode voltages during stimulation and the electrochemical impedance spectra	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)