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NCT05864807 | RECRUITING | Faecal Incontinence

UCon Treatment of the Symptoms of Faecal Incontinence (FI)
Sponsor:

InnoCon Medical

Brief Summary:

UCon is a medical device for treatment of the symptoms of overactive bladder and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g., suppress undesired bladder/bowel activity to relieve the symptoms of the patient. This clinical investigation is designed as a single-arm, prospective, single-centre, early feasibility study.

Condition or disease

Faecal Incontinence

Faecal Incontinence With Faecal Urgency

Intervention/treatment

UCon

Phase

NA

Detailed Description:

The overall purpose of the current clinical investigation is to evaluate the medical device (UCon) with respect to initial safety and device performance in a cohort of Spanish patients with FI over a treatment period of 4 weeks.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Safety and Performance of UCon for the Treatment of the Symptoms of Faecal Incontinence (FI) - An Early Feasibility Study
Actual Study Start Date : 2023-08-01
Estimated Primary Completion Date : 2025-12-01
Estimated Study Completion Date : 2025-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Participant is ≥ 18 years of age.
  • 2. Participant is showing symptoms of FI.
  • 3. Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home.
Exclusion Criteria
  • 1. Participant is medically unstable (acute illness or complication of a chronic condition that might affect the participants´ participation in the investigation).
  • 2. Participant has an active infection in the genital area.
  • 3. Participant has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function).
  • 4. Participant is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test). Women of childbearing potential must maintain effective contraception\* during the interventional period judged by the investigator.
  • 5. Participant is enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug trial or medical device investigation within four weeks to enrolment.
  • 6. Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation, e.g., denervated patients and severe diabetic neuropathy.
  • 7. Participant is currently receiving cancer treatment.
  • 8. Participant has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
  • 9. Participant does not speak and understand Spanish.
  • * The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.
UCon Treatment of the Symptoms of Faecal Incontinence (FI)

Location Details

NCT05864807

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Locations

RECRUITING

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain, 08035