Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00004073

Trial Description

start of 1:1-Block title

Title

A Pilot Study to Evaluate the Safety and Performance of Neuromuscular Electrical Stimulation (NMES) With the Inko RS Device for the Treatment of Stress Urinary Incontinence

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This is a pilot clinical study taking place at one site in Berlin, Germany using
Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of 20
women suffering from stress urinary incontinence. This involves a 12 week, 30 minute, 5 days
out of 7 set treatment program with the device. After the 12 week treatment programme the
subjects will be asked to perform daily set exercises for a further 14 weeks.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004073
  •   2012/11/09
  •   2011/11/09
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT01472068  (ClinicalTrials.gov)
  •   BMR-11-1014  (Bio-Medical Research, Ltd.)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Stress Urinary Incontinence
  •   R32 -  Unspecified urinary incontinence
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Device: Inko RS Device
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Based on a reduction in urine leakage following a standardised 1- min stress test at 1 hour post-bladder filing protocol (1-hour pad weight test) at 12 weeks compared to baseline following a 12 week treatment programme with the Inko RS Device.; time frame: 12 weeks

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- To evaluate an improvement in quality of life assessed using the Incontinence Quality of Life Questionnaire (I-QOL).; time frame: 4 wks, 8 wks and 12 weeks
- Evaluate an improvement in quality of life assessed using the Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence Questionnaire (MESA); time frame: at 4, 8 and 12 weeks

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2011/12/31
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Subjects who are female and at least 18 years of age.

- Subject has signed informed consent form prior to any study related activity

- Subjects who have previously failed a 6 week volitional pelvic floor muscle training
program.

- Subjects who have been clinically diagnosed with stress urinary incontinence and
demonstrate a >4g urine leakage following a standardised 1-minute stress test at 1
hour post-bladder filling protocol (1-hour pad weight test). Stress urinary
incontinence is defined as complaint of involuntary leakage on effort or exertion, or
on sneezing and coughing' (International Continence Society).

- Subjects who have scored at least 18 out of 27 for the Stress Incontinence Questions
and are confirmed as having predominant stress urinary incontinence on the Medical,
Epidemiologic and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire
completed at the screening assessment.

- Subjects with a Body Mass Index of < 30 kg/m2

- 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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- 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 who have or 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.

- Subject who are currently taking medication, or have taken medication in the last 4
weeks, for urinary incontinence or that effect urinary output function including
anti-cholinergics or anti-histamines or any anti-anxiety medications.

- 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 participated in a clinical study in the last 3 months.

- Any vulnerable subjects defined as individuals whose willingness to volunteer in a
clinical study may be unduly influenced by the expectation, whether justified or not,
of benefits associated with participation, or of a retaliatory response from senior
members of a hierarchy in case of refusal to participate. Examples are members of a
group with a hierarchical structure, such as medical, pharmacy, dental, and nursing
students, subordinate hospital and laboratory personnel, employees of the
pharmaceutical and medical device industry, members of the armed forces, and persons
kept in detention. Other vulnerable subjects include patients with incurable
diseases, persons in nursing homes, unemployed or impoverished persons, patients in
emergency situations, ethnic minority groups, homeless persons, nomads, refugees,
minors, and those incapable of giving consent.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Bio-Medical Research, Ltd.
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2012/10/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.