Urinary IncontinenceNCT02543242
InTone for Urinary Incontinence
A study of Urinary Incontinence, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The rationale for the conduct of this study is that the Intone device (along with pelvic physiotherapy) can be used to help females suffering from urinary stress incontinence by using electrical stimulation and biofeedback during pelvic floor muscle training. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Urinary Incontinence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Sep 2016
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female gender
- Between ages 18-70
- Diagnosed with Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI), or Mixed Urinary Incontinence (MUI)
Who cannot join
- Incontinence of less than 6 months
- pregnancy or delivery within 6 weeks
- vaginal or pelvic surgery within previous 6 months
- pelvic organ prolapse greater than stage 2 (based on POP-Q)
- active UTI or history of recurrent UTIs (more than 3 in a year)
- recurrent vaginitis (bacterial/fungal)
Show all 9Show fewer
- pelvic pain/painful bladder syndrome
- implanted cardiac device or untreated cardiac arrhythmi
- Underlying neurologic/neuromuscular disorder, or inadequate vaginal caliber (can't accommodate device).
Trial locations and contacts
1 site in 1 country.
Dean S Elterman, MD contact
Canada1 site, 1 recruiting
- Recruiting
University Health Network (Altum Health)
Toronto, Ontario, M5T 2S8
Dean Elterman, MD, dean.elterman@uhn.ca
Sara Jaffer, BSc, sara.jaffer@uhn.ca
About this study
Official title: Effectiveness of the Intone Pelvic Floor Device for Urinary Incontinence
The rationale for the conduct of this study is that the Intone device (along with pelvic physiotherapy) can be used to help females suffering from urinary stress incontinence by using electrical stimulation and biofeedback during pelvic floor muscle training. This investigation is important because it can aid in the greater acceptance and development of non-surgical treatments for Stress Urinary Incontinence if these areas are looked into. The study results will address if the Intone device is beneficial and promotes long-term improvement in women that suffer from urinary incontinence.
Read the detailed description
Urinary incontinence is very common in women and is linked to a reduced quality of life (Corcos et al., 2002). The three main types of urinary incontinence are Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI) and Mixed Urinary Incontinence (MUI). SUI and UUI involve losing urine involuntarily. In SUI this is during either effortful motion such as coughing or sneezing, or in UUI is associated with a feeling of urgency. Urinary incontinence has various treatment options including: surgery, medication, pelvic floor muscle exercises and electrical stimulation (Norton \& Brubaker, 2006).
The most common physiotherapy treatment used for women with urinary incontinence is pelvic floor muscle training (Dumoulin \& Hay-Smith, 2010). Several studies have investigated the effects of PFMT in comparison to other treatments such as no treatment and vaginal cones. They found that women in the PFMT group reported more improvement and better quality of life than women in other treatment groups. The PFMT group also had fewer daily incontinence episodes and less leakage (Bø, Talseth, \& Holme, 1999; Dumoulin \& Hay-Smith, 2010).
Electrical stimulation of the pelvic floor muscles is another treatment for urinary incontinence, and may often be combined with PFMT. Success rates of electrical stimulation in treating urinary incontinence range from 50-90% (Bent et al., 1993; Erikson, Bergmann, \& Mjølnerød, 1987; Fall, 1984; Pelvnik et al., 1986).
A new product has been developed called InTone which combines PFMT, electrical stimulation and biofeedback. This device is inserted into the vagina and facilitates PFMT while providing electrical stimulation and biofeedback to the patient. This study will examine the effectiveness of the InTone device in treating urinary incontinence in women.
- Conditions
- Urinary Incontinence
- Being tested
- InToneTM (InControl Medical, LLC) - Medical Device
- Keywords
- Urinary Incontinence, Stress Urinary Incontinence, Urge Incontinence, Mixed Urinary Incontience, Female Pelvic Health
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InToneTM (InControl Medical, LLC) - Medical DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will undergo the InTone TM (InControl Medical, LLC) medical device treatment for Urinary Incontinence. The frequency of treatment is once/day (12 minutes), 5-6 days/week. The route of administration is vaginal. Receives: Device: InToneTM (InControl Medical, LLC) - Medical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pad Test Weighting
urine voiding measure
Measured: up to 26 weeks
Secondary outcomes (6)
Urinary Distress Inventory (UDI-6)
Questionnaire that assesses symptom distress and the impact on daily life of urinary incontinence
Measured: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
Incontinence Impact Questionnaire Short Form (IIQ-7)
Assesses symptom distress and the impact on daily life of urinary incontinence
Measured: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Evaluates sexual function in women with pelvic organ prolapse and/or urinary incontinence.
Measured: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
Urinary Incontinence Quality of Life Scale (IQOL)
A self-reported quality of life measure specific to urinary incontinence (UI),
Measured: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ UI SF)
A subjective measure of severity of urinary loss and quality of life for those with urinary incontinence.
Measured: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
48 Hour Bladder Diary
A diary containing details of every void. The time, amount leaked and activity during the leakage are recorded for 48 hours.
Measured: up to 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dean S Elterman, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543242
- Sponsor's protocol ID
- InTone
- Status last verified
- Sep 2015
- First submitted
- 3 Sep 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Brubaker L, Benson JT, Bent A, Clark A, Shott S. Transvaginal electrical stimulation for female urinary incontinence. Am J Obstet Gynecol. 1997 Sep;177(3):536-40. doi: 10.1016/s0002-9378(97)70142-x.
PubMed 9322620Corcos J, Beaulieu S, Donovan J, Naughton M, Gotoh M; Symptom Quality of Life Assesment Committee of the First International Consultation on Incontinence. Quality of life assessment in men and women with urinary incontinence. J Urol. 2002 Sep;168(3):896-905. doi: 10.1016/S0022-5347(05)64540-5.
PubMed 12187188Dumoulin C, Hay-Smith J, Habee-Seguin GM, Mercier J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a short version Cochrane systematic review with meta-analysis. Neurourol Urodyn. 2015 Apr;34(4):300-8. doi: 10.1002/nau.22700. Epub 2014 Nov 18.
PubMed 25408383Eriksen BC, Bergmann S, Mjolnerod OK. Effect of anal electrostimulation with the 'Incontan' device in women with urinary incontinence. Br J Obstet Gynaecol. 1987 Feb;94(2):147-56. doi: 10.1111/j.1471-0528.1987.tb02342.x.
PubMed 3493802Fall M. Does electrostimulation cure urinary incontinence? J Urol. 1984 Apr;131(4):664-7. doi: 10.1016/s0022-5347(17)50566-2.
PubMed 6608590Bo K, Talseth T, Holme I. Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. BMJ. 1999 Feb 20;318(7182):487-93. doi: 10.1136/bmj.318.7182.487.
PubMed 10024253Norton P, Brubaker L. Urinary incontinence in women. Lancet. 2006 Jan 7;367(9504):57-67. doi: 10.1016/S0140-6736(06)67925-7.
PubMed 16399154Tjelum KB, Lose G, Abel I, Pedersen LM. [Electrostimulation of the pelvic floor muscles in urinary incontinence]. Ugeskr Laeger. 1994 Apr 11;156(15):2214-6. Danish.
PubMed 8016945
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Intone Pelvic Floor Device for Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02543242
- Acronym / sponsor ID
- InTone
- Conditions
- Urinary Incontinence
- Keywords
- Urinary Incontinence, Stress Urinary Incontinence, Urge Incontinence, Mixed Urinary Incontience, Female Pelvic Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 7 Sep 2015 (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.
The rationale for the conduct of this study is that the Intone device (along with pelvic physiotherapy) can be used to help females suffering from urinary stress incontinence by using electrical stimulation and biofeedback during pelvic floor muscle training. This investigation is important because it can aid in the greater acceptance and development of non-surgical treatments for Stress Urinary Incontinence if these areas are looked into. The study results will address if the Intone device is beneficial and promotes long-term improvement in women that suffer from urinary incontinence.
Detailed description
Urinary incontinence is very common in women and is linked to a reduced quality of life (Corcos et al., 2002). The three main types of urinary incontinence are Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI) and Mixed Urinary Incontinence (MUI). SUI and UUI involve losing urine involuntarily. In SUI this is during either effortful motion such as coughing or sneezing, or in UUI is associated with a feeling of urgency. Urinary incontinence has various treatment options including: surgery, medication, pelvic floor muscle exercises and electrical stimulation (Norton \& Brubaker, 2006).
The most common physiotherapy treatment used for women with urinary incontinence is pelvic floor muscle training (Dumoulin \& Hay-Smith, 2010). Several studies have investigated the effects of PFMT in comparison to other treatments such as no treatment and vaginal cones. They found that women in the PFMT group reported more improvement and better quality of life than women in other treatment groups. The PFMT group also had fewer daily incontinence episodes and less leakage (Bø, Talseth, \& Holme, 1999; Dumoulin \& Hay-Smith, 2010).
Electrical stimulation of the pelvic floor muscles is another treatment for urinary incontinence, and may often be combined with PFMT. Success rates of electrical stimulation in treating urinary incontinence range from 50-90% (Bent et al., 1993; Erikson, Bergmann, \& Mjølnerød, 1987; Fall, 1984; Pelvnik et al., 1986).
A new product has been developed called InTone which combines PFMT, electrical stimulation and biofeedback. This device is inserted into the vagina and facilitates PFMT while providing electrical stimulation and biofeedback to the patient. This study will examine the effectiveness of the InTone device in treating urinary incontinence in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: InToneTM (InControl Medical, LLC) - Medical DeviceParticipants will undergo the InTone TM (InControl Medical, LLC) medical device treatment for Urinary Incontinence. The frequency of treatment is once/day (12 minutes), 5-6 days/week. The route of administration is vaginal. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female gender
- Between ages 18-70
- Diagnosed with Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI), or Mixed Urinary Incontinence (MUI)
Key exclusion criteria (9 listed)
- Incontinence of less than 6 months
- pregnancy or delivery within 6 weeks
- vaginal or pelvic surgery within previous 6 months
- pelvic organ prolapse greater than stage 2 (based on POP-Q)
- active UTI or history of recurrent UTIs (more than 3 in a year)
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 |
|---|---|---|
| InToneTM (InControl Medical, LLC) - Medical Device | Device | Intervention |
Primary outcome
Pad Test Weighting
Time frame: up to 26 weeks
urine voiding measure
6 secondary outcomes
Urinary Distress Inventory (UDI-6)
Time frame: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
Incontinence Impact Questionnaire Short Form (IIQ-7)
Time frame: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Time frame: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
Urinary Incontinence Quality of Life Scale (IQOL)
Time frame: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ UI SF)
Time frame: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
48 Hour Bladder Diary
Time frame: up to 6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Background: PubMed 9322620Brubaker L, Benson JT, Bent A, Clark A, Shott S. Transvaginal electrical stimulation for female urinary incontinence. Am J Obstet Gynecol. 1997 Sep;177(3):536-40. doi: 10.1016/s0002-9378(97)70142-x.
- Background: PubMed 12187188Corcos J, Beaulieu S, Donovan J, Naughton M, Gotoh M; Symptom Quality of Life Assesment Committee of the First International Consultation on Incontinence. Quality of life assessment in men and women with urinary incontinence. J Urol. 2002 Sep;168(3):896-905. doi: 10.1016/S0022-5347(05)64540-5.
- Background: PubMed 25408383Dumoulin C, Hay-Smith J, Habee-Seguin GM, Mercier J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a short version Cochrane systematic review with meta-analysis. Neurourol Urodyn. 2015 Apr;34(4):300-8. doi: 10.1002/nau.22700. Epub 2014 Nov 18.
- Background: PubMed 3493802Eriksen BC, Bergmann S, Mjolnerod OK. Effect of anal electrostimulation with the 'Incontan' device in women with urinary incontinence. Br J Obstet Gynaecol. 1987 Feb;94(2):147-56. doi: 10.1111/j.1471-0528.1987.tb02342.x.
- Background: PubMed 6608590Fall M. Does electrostimulation cure urinary incontinence? J Urol. 1984 Apr;131(4):664-7. doi: 10.1016/s0022-5347(17)50566-2.
- Background: PubMed 10024253Bo K, Talseth T, Holme I. Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. BMJ. 1999 Feb 20;318(7182):487-93. doi: 10.1136/bmj.318.7182.487.
- Background: PubMed 16399154Norton P, Brubaker L. Urinary incontinence in women. Lancet. 2006 Jan 7;367(9504):57-67. doi: 10.1016/S0140-6736(06)67925-7.
- Background: PubMed 8016945Tjelum KB, Lose G, Abel I, Pedersen LM. [Electrostimulation of the pelvic floor muscles in urinary incontinence]. Ugeskr Laeger. 1994 Apr 11;156(15):2214-6. Danish.
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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.
Dean S Elterman, MD contact
Dean S Elterman, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Urinary Incontinence, run by University Health Network, Toronto at 1 site in Canada.
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: status not confirmed, as of the sponsor's last update on 7 Sep 2015. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dean S Elterman, MD (dean.elterman@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pad Test Weighting (time frame: up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02543242, which also lists 8 linked publications.
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 7 Sep 2015.