Trial document

This study has been imported from without additional data checks.
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Trial Description

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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

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Trial Acronym


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URL of the Trial


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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.

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Brief Summary in Scientific Language


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Organizational Data

  •   DRKS00004073
  •   2012/11/09
  •   2011/11/09
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT01472068  (
  •   BMR-11-1014  (Bio-Medical Research, Ltd.)
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Health Condition or Problem studied

  •   Stress Urinary Incontinence
  •   R32 -  Unspecified urinary incontinence
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Interventions/Observational Groups

  •   Device: Inko RS Device
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  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I
  •   [---]*
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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

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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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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  •   [---]*
  •   2011/12/31
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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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

- 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.

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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

- 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

- 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.

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  • start of 1:1-Block address primary-sponsor
    • Bio-Medical Research, Ltd.
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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  •   Recruiting complete, follow-up complete
  •   2012/10/01
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Trial Publications, Results and other Documents

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The parameters in and DRKS are not identical. Therefore the data import from 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.