Urinary IncontinenceNCT03477214
Tactile Imaging and Electromyography
An observational study of Urinary Incontinence and Overactive Bladder, run by Advanced Tactile Imaging, Inc. at 2 sites in United States.
Trial summary
Urinary incontinence (UI) and overactive bladder (OAB) in women has high prevalence which is increasing with the age. In adults aged 40 and older in the US demonstrated prevalence rate of 27.2% among man and 43.1% among women, respectively. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Overactive Bladder
- What is being tested?
- Biomechanical and electromyography mapping
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Dec 2017to 15 Mar 2020
- Phase
- Observational
- 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 21 years and older
- Women only
- Adult, Older adult
Study population: There is no inclusion or exclusion criteria based on ethnic background, religion, or other division of population other than these stated in Exclusion Criteria section.
Who may be able to join
- Women above age of 21 with normal pelvic floor condition for the control
- Women with SUI conditions as defined by International Continence Society guidelines
- Women with OAB conditions as defined by American Urological Association and Society of Urodinamics, Female Pelvic Medicine \& Urogenital Reconstruction.
Who cannot join
- Any prior pelvic floor surgery related to SUI, POP or OAB conditions
- Active skin infection or ulceration within the vagina
- Presence of the vaginal septum
- Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
- Ongoing radiation therapy for pelvic cancer; impacted stool
- Surgically absent rectum or bladder
Show all 9Show fewer
- Sever hemorrhoids
- Significant circulatory or cardiac conditions that could cause excessive risk
- Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute of Female Pelvic Medicine & Reconstructive Surgery (IFPM)
Allentown, Pennsylvania, 18103
Princeton Urogynecology
Princeton, New Jersey, 08540
About this study
Official title: Tactile Imaging and Electromyography of Female Pelvic Floor
Urinary incontinence (UI) and overactive bladder (OAB) in women has high prevalence which is increasing with the age. In adults aged 40 and older in the US demonstrated prevalence rate of 27.2% among man and 43.1% among women, respectively. Urine Incontinence was reported to affect 15% of women ages 40 to 49, 25% ages 60 to 69, and 38% of women age 80 and older.
Read the detailed description
Pelvic floor disorders result from neuro-urinary pathology as well as muscle functional impairment due to changes in bio-mechanical properties of soft tissues with the age. That is why pelvic floor characterization and diagnosis must include electomyographic (EMG) and biomechanical measurements (pressure) or better if EMG and tactile imaging with improved spatial resolution. The quantitative and objective imaging data for pelvic floor conditions could allow an effective treatment of OAB and UI.
In this research the investigators propose to develop a new device for accurate diagnosis of the diseased conditions by measuring the pelvic floor muscles strength and EMG activity. The value to society is high given by the prevalence of OAB and UI.
- Conditions
- Urinary Incontinence, Overactive Bladder
- Being tested
- Biomechanical and electromyography mapping
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomechanical and electromyography mappingDiagnostic test
The vaginal tactile imaging probe will acquire biomechanical and electromyography high definition measurements for anterior and posterior compartments along entire vagina.
| Study group | Role | What they receive |
|---|---|---|
| Normal | No UI, no OAB conditions. Transvaginal biomechanical and electromyography mapping will be completed. Receives: Diagnostic Test: Biomechanical and electromyography mapping | |
| Urinary incontinence | Urinary incontinence conditions. Transvaginal biomechanical and electromyography mapping will be completed. Receives: Diagnostic Test: Biomechanical and electromyography mapping | |
| Overactive bladder | Overactive bladder conditions Receives: Diagnostic Test: Biomechanical and electromyography mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transvaginal biomechanical maps
Transvaginal biomechanical maps (pressures in Pa) will be recorded and compared for UI and OAB versus normal conditions.
Measured: Four months
Transvaginal electromyography maps
Transvaginal electromyography maps (electrical voltages in mV) will be recorded and compared for UI and OAB versus normal conditions.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start24 Dec 2017
- Primary completion10 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Tactile Imaging, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Princeton Urogynecology
- Responsible party
- Sponsor
- Investigators
- Heather van Raalte, MD, Study director, Princeton Urogynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477214
- Sponsor's protocol ID
- TIEMG08
- Status last verified
- Apr 2020
- First submitted
- 15 Feb 2018
- Last updated
- 13 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tactile Imaging and Electromyography of Female Pelvic Floor
- ClinicalTrials.gov ID
- NCT03477214
- Acronym / sponsor ID
- TIEMG08
- Conditions
- Urinary Incontinence, Overactive Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Advanced Tactile Imaging, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Princeton Urogynecology
- Study start
- 24 Dec 2017 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 26 Mar 2018 (actual)
- 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.
Urinary incontinence (UI) and overactive bladder (OAB) in women has high prevalence which is increasing with the age. In adults aged 40 and older in the US demonstrated prevalence rate of 27.2% among man and 43.1% among women, respectively. Urine Incontinence was reported to affect 15% of women ages 40 to 49, 25% ages 60 to 69, and 38% of women age 80 and older.
Detailed description
Pelvic floor disorders result from neuro-urinary pathology as well as muscle functional impairment due to changes in bio-mechanical properties of soft tissues with the age. That is why pelvic floor characterization and diagnosis must include electomyographic (EMG) and biomechanical measurements (pressure) or better if EMG and tactile imaging with improved spatial resolution. The quantitative and objective imaging data for pelvic floor conditions could allow an effective treatment of OAB and UI.
In this research the investigators propose to develop a new device for accurate diagnosis of the diseased conditions by measuring the pelvic floor muscles strength and EMG activity. The value to society is high given by the prevalence of OAB and UI.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Diagnostic Test: Biomechanical and electromyography mappingNo UI, no OAB conditions. Transvaginal biomechanical and electromyography mapping will be completed. |
| Urinary incontinence | – | Diagnostic Test: Biomechanical and electromyography mappingUrinary incontinence conditions. Transvaginal biomechanical and electromyography mapping will be completed. |
| Overactive bladder | – | Diagnostic Test: Biomechanical and electromyography mappingOveractive bladder conditions |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- There is no inclusion or exclusion criteria based on ethnic background, religion, or other division of population other than these stated in Exclusion Criteria section.
Key inclusion criteria (3 listed)
- Women above age of 21 with normal pelvic floor condition for the control
- Women with SUI conditions as defined by International Continence Society guidelines
- Women with OAB conditions as defined by American Urological Association and Society of Urodinamics, Female Pelvic Medicine \& Urogenital Reconstruction.
Key exclusion criteria (9 listed)
- Any prior pelvic floor surgery related to SUI, POP or OAB conditions
- Active skin infection or ulceration within the vagina
- Presence of the vaginal septum
- Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
- Ongoing radiation therapy for pelvic cancer; impacted stool
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 |
|---|---|---|
| Biomechanical and electromyography mappingThe vaginal tactile imaging probe will acquire biomechanical and electromyography high definition measurements for anterior and posterior compartments along entire vagina. | Diagnostic test | Normal, Overactive bladder, Urinary incontinence |
Primary outcome
Transvaginal biomechanical maps
Time frame: Four months
Transvaginal biomechanical maps (pressures in Pa) will be recorded and compared for UI and OAB versus normal conditions.
Transvaginal electromyography maps
Time frame: Four months
Transvaginal electromyography maps (electrical voltages in mV) will be recorded and compared for UI and OAB versus normal conditions.
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 13 Apr 2020.
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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.
Heather van Raalte, MD study director
Princeton Urogynecology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Overactive Bladder, run by Advanced Tactile Imaging, Inc. at 2 sites in United States.
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 3 inclusion and 9 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 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
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?
Transvaginal biomechanical maps (time frame: Four months). The study lists 2 primary outcomes in all. 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 13 Apr 2020.