Clinical trial NCT01614730: User Evaluation in Healthy Volunteers to Verify no Pelvic Floor Contraction is Stimulated When the Modified Neurotech Vital Device is Used Compared to the Neurotech Vital Device
Official title: User Evaluation Trial in Healthy Volunteers : Modified Neurotech Vital Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Contraction of Pelvic Floor Muscle Using EMS
Keywords: EMS
Modified Device
Lead sponsor: Bio-Medical Research, Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This user evaluation study is to verify that the Modified Neurotech Vital Device does not stimulate the pelvic floor muscles compared with the Neurotech Vital Device.

Detailed description: This user evaluation study is to verify that the Modified Neurotech Vital Device does not stimulate the pelvic floor muscles compared with the Neurotech Vital Device. Stimulation of the pelvic floor muscles will be assessed by using sonographic/real time ultrasound imaging/recording with displacement measurement using onscreen callipers on the sonogram unit to assess contractions.

Eligibility criteria: Inclusion Criteria:

Subjects who meet the following inclusion criteria will be included in the study.

* Subjects who are female and at least 18 years of age.
* Subjects who, in the opinion of the Investigator, are deemed healthy.
* Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
* Subjects who are able to understand this study and are willing to complete all the study assessments.

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from participation in the study.

  * Subjects who have an existing medical condition that would compromise their participation in the study.
  * Subjects who have a physical condition that would make them unable to perform the study procedures.
  * Subjects with a history of any respiratory condition including a chronic cough.
  * Subjects with a history of an underlying neurological condition.
  * Subjects with a history of low back pain involving the spinal nerve root.
  * Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
  * Subjects who have previously had any uro-gynaecological related surgery excluding hysterectomy.
  * Subjects with a clinical diagnosis of prolapse greater than Stage 2.
  * Subjects who are pregnant or could be pregnant.
  * Subjects who are less than 6 months post-partum or who are lactating.
  * Subjects who have any intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine.
  * Subjects with pelvic pain or fibromyalgia or paravaginal defect.
  * Subjects with an active implanted medical device (ie pacemaker, pump etc).
  * Subjects with a history of heart disease or stroke.
  * Subjects with a known cancer.
  * Subjects with an injury or disability affecting any part of their body which will be in contact with the garment.
  * Subjects who are currently involved in any injury litigation claims.
  * Subjects who have been committed to an institution by virtue of an order issued either by the courts or by an authority.
  * Subjects who have participated in a clinical study in the last 3 months.

Primary outcomes:
measure: Using a sonographic/real time ultrasound imaging machine detect if a contraction is stimulated by the 5 minute treatment with the modified Neurotech Device and 5 minute treatment with the Neurotech Vital Device.
timeFrame: 5 minutes treatment with each device to measure if contraction occurrs on the ultrasound
Secondary outcomes:
measure: Healthy Volunteers feedback questionnaires
timeFrame: after 5 minutes of treatment
Other outcomes:
Locations:
Study officials:
References: