Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)

Official title

Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - An Early Feasibility Study

Overview

UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). 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, multi-centre, and early feasibility study.

Detailed description

The overall purpose of the current clinical investigation is to evaluate the medical device with a UCon-Bar Electrode with respect to its initial safety and device performance in a cohort of 40 female patients with OAB/BD over a period of 12 weeks.

The investigation consists of two periods: a screening period and an intervention period.

During the screening period, the participants will be using UCon with a Patch Electrode and complete a 4 week stimulation period at home. The screening period will determine if participants fulfil the criteria to participate in the intervention period.

During the intervention period, the UCon Bar Electrode will be inserted in the clitoral hood. After a recovery period (4-8 weeks), the participants will be using UCon with the Bar Electrode and complete wither a 4 week or a 12 week stimulation period at home.

Interventions

• Device UCon-Bar
  The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) for either 4 weeks or 12 weeks using UCon with the Bar electrode

Primary outcome measures

• PRIMARY SAFETY: ratio of participants with successful insertion of the UCon Bar Electrode. [Time frame: After 4 weeks and 12 weeks]
• PRIMARY PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms [Time frame: Change from baseline at 4 weeks and/or 12 weeks]

Secondary outcome measures (6)

• SECONDARY SAFETY: Characterization, including frequency and severity of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon-Bar Electrode. [Time frame: After 4 weeks and 12 weeks]
• SECONDARY PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms [Time frame: Change from baseline at 4 weeks and/or 12 weeks]
• SECONDARY PERFORMANCE: assess whether participants using UCon Bar Electrode experience a change in their quality of life [Time frame: Change from baseline at 4 weeks and/or 12 weeks]
• SECONDARY PERFORMANCE: assess whether participants using UCon Bar Electrode experience an impression of treatment improvement [Time frame: After 4 week screening period, 4 weeks, and 12 weeks]
• SECONDARY PERFORMANCE: ratio of participant that accept UCon and DGN stimulation [Device and treatment acceptability of UCon] [Time frame: After 4 week screening period, 4 weeks, and 12 weeks]
• Secondary PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms during the screening period can be reproduced in the intervention period. [Time frame: Change from screening period at 4 weeks and/or 12 weeks]

Eligibility criteria

Inclusion criteria

• Participant is female
• Participant is ≥ 18 years of age.
• Participant is diagnosed with OAB or BD.

OAB: Urinary urgency usually with one or more of the following:

i. Urinary urgency incontinence (≥1 per/week). ii. Urinary frequency (≥8 voiding/day without polyuria). iii. Nocturia (≥2 voiding/night without nocturnal polyuria).

BD: One or more of the following:

i. Faecal urgency (≥3 urgencies pr. week) together with registration of urgency in St. Mark´s and a St. Mark´s score ≥9.

ii. Faecal incontinence (urge/passive) (≥1 per/week).

• 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, apart from the OAB or BD, 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 devices (any medical device that uses electrical energy or other sources 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 clinical investigation.
• Participant is enrolled or planning to enrol in another conflicting clinical investigation or was enrolled in an investigational drug trial or medical device investigation within four weeks of enrolment.
• Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
• Participant has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has received radiation therapy in the pelvic region.
• Participant has addictive behaviour defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
• Participant does not speak or understand Danish.

• The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Denmark · 3 centers

• Aarhus University Hospital — Aarhus
• Herlev Hospital — Herlev
• Odense University Hospital — Odense

Identifiers

NCT: NCT06091566 · DK_FEAS_02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗