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Neurotech Vital Device For The Treatment Of Stress Urinary Incontinence

NCT02214784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-02-05

No results posted yet for this study

Summary

Stress Urinary Incontinence (SUI) is described as an uncontrolled loss of urine which happens when physical activities such as running, jumping and lifting etc are carried out or when increased pressure to the bladder in everyday life is applied by simply sneezing or coughing.

There are various treatment options available - surgical operations, pelvic floor exercises/muscle training and electrical stimulation. This study aims to prove that using the Neurotech Vital device for 12 weeks can stimulate the pelvic floor muscles to strengthen and tone them and in doing so improving stress urinary incontinence. We are comparing the Neurotech Vital device with an altered Neurotech Vital device that does not give the same stimulation treatment. There is a 50% chance of you receiving the altered device, if you do, you will be offered the non-altered Neurotech vital device after your first 12 week treatment programme. Both devices are identical in looks, but give different stimulations through the skin contact electrodes.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Active Neurotech Vital

12 weeks treatment for 30 minutes per day, 5 days out of 7.

DEVICE

Modified Neurotech Vital Device

12 weeks treatment for 30 minutes per day for 5 days out of 7.

Sponsors & Collaborators

  • Atlantic Therapeutics

    lead OTHER

Principal Investigators

  • R Tunn, Professor · St Hedwig Krankenhaus, Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02214784 on ClinicalTrials.gov