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

NCT01614730 | Completed Early Phase 1

• 1 other identifier: BMR-12-1002
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Contraction of Pelvic Floor Muscle Using EMS

Keywords

EMS; Modified Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Healthy Volunteers feedback questionnaires

  after 5 minutes of treatment

Study Arms (2)

Modified Neurotech Vital Device

SHAM COMPARATOR

Checking to see no contraction is stimulated during treatment with the Modified Neurotech Device

Device: Modified Neurotech Vital Device

Neurotech Vital Device

ACTIVE COMPARATOR

Checking to see a contraction is stimulated during treatment of the Neurotech Vital Device

Device: Neurotech Vital Device

Interventions

Modified Neurotech Vital Device DEVICE

verify no contraction is stimulated in the Modified Neurotech Vital.

Also known as: Modified Neurotech Vital Device, EMS

Modified Neurotech Vital Device

Neurotech Vital Device DEVICE

Checking there is a contraction of the pelvic floor muscle when the treatment is administered with the Neurotech Vital Device

Also known as: EMS, Neurotech Vital

Neurotech Vital Device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bio-Medical Research, Ltd.: lead

MeSH Terms

Interventions

Emergency Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 9, 2012

Record last verified: 2012-06