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 (BMR-12-1002)

User Evaluation Trial in Healthy Volunteers : Modified Neurotech Vital Device

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.

Study Overview

• Status: Completed
• Conditions: Contraction of Pelvic Floor Muscle Using EMS
• Intervention / Treatment: Device: Modified Neurotech Vital Device; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Modified Neurotech Vital Device; Checking to see no contraction is stimulated during treatment with the Modified Neurotech Device	Device: Modified Neurotech Vital Device; verify no contraction is stimulated in the Modified Neurotech Vital.; Other Names: Modified Neurotech Vital Device, EMS
Active Comparator: Neurotech Vital Device; Checking to see a contraction is stimulated during treatment of the Neurotech Vital Device	Device: Neurotech Vital Device; Checking there is a contraction of the pelvic floor muscle when the treatment is administered with the Neurotech Vital Device; Other Names: EMS, Neurotech Vital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The primary endpoint of the study is to demonstrate that no volunteers elicit a contraction of the pelvic floor muscle with the Modified Neurotech Vital Device and that all the volunteers elicit a contraction of the pelvic floor muscle with the Neurotech Vital Device. Contraction of the pelvic floor muscles will be assessed by using sonographic/real time ultrasound imaging/recording (mean of three measurements of pelvic floor displacement achieved during maximum threshold intensity electrical stimulation).	5 minutes treatment with each device to measure if contraction occurrs on the ultrasound

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthy Volunteers feedback questionnaires	The secondary objective of this user evaluation study is to verify that the Modified Neurotech Vital Device is perceived by the volunteers as a valid treatment option. The Modified Neurotech Vital Device will be considered an acceptable treatment option in relation to stimulation sensation if 70% yes/not sure responses are obtained to the question 'given what you have been told about this treatment, do you believe it could be effective?'.	after 5 minutes of treatment

Collaborators and Investigators

• Sponsor: Bio-Medical Research, Ltd.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 6, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (Estimate): June 8, 2012

Study Record Updates

• Last Update Posted (Estimate): July 9, 2012
• Last Update Submitted That Met QC Criteria: July 5, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: EMS; Modified Device
• Other Study ID Numbers: BMR-12-1002