Stress Urinary IncontinencePhase 1NCT01472068
A Pilot Study to Evaluate Safety and Performance of Neuromuscular Electrical Stimulation With the Inko RS Device for the Treatment of Stress Urinary Incontinence
A Phase 1 study testing Inko RS Device in people with Stress Urinary Incontinence, run by Bio-Medical Research, Ltd. at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Inko RS Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2011to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Inko RS Device
- Keywords
- Incontinence, NMES
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inko RS DeviceDevice
30 minute pre-programmed treatment for 5 days out of 7. Treatment to be carried out while standing.
| Study group | Role | What they receive |
|---|---|---|
| Inko RS device | Experimental | 30 minutes of treatment with the Inko RS device, five days each week, for 12 weeks. Receives: Device: Inko RS Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
To evaluate an improvement in quality of life assessed using the Incontinence Quality of Life Questionnaire (I-QOL).
Measured: 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)
Measured: at 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Medical Research, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472068
- Sponsor's protocol ID
- BMR-11-1014
- Status last verified
- Feb 2016
- First submitted
- 9 Nov 2011
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01472068
- Acronym / sponsor ID
- BMR-11-1014
- Conditions
- Stress Urinary Incontinence
- Keywords
- Incontinence, NMES
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Bio-Medical Research, Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inko RS device | Experimental | Device: Inko RS Device30 minutes of treatment with the Inko RS device, five days each week, for 12 weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inko RS Device30 minute pre-programmed treatment for 5 days out of 7. Treatment to be carried out while standing. | Device | Inko RS device |
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inko RS Device in people with Stress Urinary Incontinence, run by Bio-Medical Research, Ltd. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.