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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

Not Applicable

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 : 20 participants
Masking : None (Open Label)
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 : August 1, 2023
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2024
Arm Intervention/treatment

Experimental: Interventional arm

Electrical stimulation to the dorsal genital nerve.

Device: UCon
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Participant is ≥ 18 years of age.
  • Participant is showing symptoms of FI.
  • 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
  • Participant is medically unstable (acute illness or complication of a chronic condition that might affect the participants´ participation in the investigation).
  • Participant has an active infection in the genital area.
  • 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).
  • 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.
  • 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.
  • 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.
  • Participant is currently receiving cancer treatment.
  • Participant has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
  • 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)

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UCon Treatment of the Symptoms of Faecal Incontinence (FI)

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Locations

Recruiting

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain, 08035