Segmental Dysfunction of the Pelvic RegioniballNCT02865954
Iball & Pelvic Floor Muscle Training
A study testing iball (mhealth application) in people with Segmental Dysfunction of the Pelvic Region, run by McMaster University.
Trial summary
he postpartum period is vulnerable to dysfunction of the pelvic floor musculature, which is associated with incontinence, pain, reduced stability of the core and functional deficits. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Segmental Dysfunction of the Pelvic Region
- What is being tested?
- iball (mhealth application)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 1 Jul 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women in their third trimester, first pregnancy.
Who cannot join
- Currently seeing a pelvic health physiotherapists or participating in a pelvic floor fitness program.
About this study
Official title: Use of Iball Mobile Health Technology in Pelvic Floor Muscle Training in the Postpartum Period: a Pilot Mixed Methods Study
he postpartum period is vulnerable to dysfunction of the pelvic floor musculature, which is associated with incontinence, pain, reduced stability of the core and functional deficits. The Society of Obstetricians and Gynaecologists of Canada recommends instruction on the correct performance of pelvic floor muscle exercises, commonly known as Kegels, as standard care. However, only a small proportion of women seek medical care for incontinence in Canada. Recently, there has been an influx of mobile Health technology applications marketed for pelvic floor restoration and fitness that have not been studied. The existence of mHealth technologies may represent an innovative mode to support pelvic health, however systematic exploration to substantiate claims and proposed benefit is required. This pilot study aims to understand the utility of a new mobile health application, iball, as a rehabilitation tool to promote optimal pelvic floor function and to correct pregnancy related pelvic floor dysfunction. The iball is comprised of a device and a mobile app, and it has been brought to market in Europe as a consumer product. The study aims to assess the acceptability, feasibility, and effectiveness of the iball as a pelvic floor muscle training intervention, in comparison to standard care.
Read the detailed description
Participants would be recruited through three midwifery practices: 1) The Hamilton Midwives; 2) Burlington \& Area Midwives Inc.; and 3) Community Midwives of Halton. Women in the third trimester of their first pregnancy, presenting at these sites will be invited to participate. The goal is to enrol a heterogeneous sample of pregnant women in the Hamilton-Halton region.
A two-step strategy will be used to recruit study participants. First, recruiting sites will attend an information session related to the study. Recruitment posters with tear-off tabs containing the study email (iballstudy@gmail.com) will be posted at the sites. Interested participants will contact the study co-ordinator. Over the phone, the study co-ordinator will determine that the patient is eligible, review the letter of information with the patient, and schedule them for a baseline assessment at approximately 6-weeks post-partum. The letter of information will be emailed to the patient so that they may follow along during the review. All Internet transmission will be performed on campus through MacSecure, or performed off campus through a Virtual Private Network (VPN) provided by McMaster University.
The patient will provide informed, written consent at the baseline appointment and prior to the assessment.
The study compares a 16-week iball pelvic floor training protocol to a 16-week standard care regimen. Sixty participants will be recruited and randomly assigned to the standard care (control) group or the iball intervention group. All participants will meet with an assessor (Dr. Sinead Dufour or Dr. Donna Fedorkow) to undergo a pre-and a post-intervention assessment. Each assessment (30min) will consist of a (15min) internal pelvic exam, following the PERFECT criteria, and two (15min) self-report questionnaires, the Urogenital Distress Inventory-Short Form (UDI-6) and the Incontinence Impact Questionnaire-Short Form (IIQ-7). The pre-study assessment will take place approximately 6 weeks post-partum. The post-study assessment will take place at the end of the 16-week study period. At 8 weeks, midway through the intervention period, all participants will be emailed by the study co-ordinator as a means to provide any support that might be needed.
At the pre-study assessment, the standard care group will receive instructions on how to perform a correct pelvic floor contraction through a digital pelvic examination. In addition to receiving the same standard care instructions, the iball intervention group will undergo a training session (15min) on how to use the iball device and app with the research co-ordinator.
The post-study assessment will require additional time from both groups. The standard care group will answer three self-administered close-ended questions (5min). In addition to answering two of the three close-ended questions (5min), the intervention group will also participate in a semi-structured interview (30min) with the research assistant either in-person or over the phone, depending on the participant's preference.
- Being tested
- iball (mhealth application)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iball (mhealth application)Device
mhealth application and associated device to support activation of the pelvic floor muscles.
| Study group | Role | What they receive |
|---|---|---|
| iball intervention | Experimental | Use of iball pelvic floor training mhealth application for 16 weeks. Receives: Device: iball (mhealth application) |
| Standard Care | No intervention | Standard Care - control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the iball intervention (via qualitative data collection)
- Tell me about your experiences using the iball device?
- What aspects of iball were the most useful or helpful?
- Which aspects of iball were least useful or helpful?
- Are there any changes you would make to the iball device or app?
- If you had to explain iball to friend, what would you say?
- Would you recommend it to a friend - why or why not?
- Do you plan on continuing to use iball at this time? Why or why not?
- Would you consider using iball again in the future?
Measured: 16 weeks
Secondary outcomes (3)
PERFECT - pelvic floor exam scores
Measured: 16 weeks
Urinary Distress Inventory (UDI-6)
Standardized outcome measure
Measured: 16 weeks
Incontinence Impact Questionnaire (IIQ-7)
Standardized outcome measure
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start1 Jul 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Segmental Dysfunction of the Pelvic RegionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinead Dufour, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865954
- Sponsor's protocol ID
- iball_McMaster
- Acronym
- iball
- Status last verified
- Aug 2018
- First submitted
- 27 Jul 2016
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
PubMed 32378735Dufour S, Fedorkow D, Kun J, Deng SX, Fang Q. Exploring the Impact of a Mobile Health Solution for Postpartum Pelvic Floor Muscle Training: Pilot Randomized Controlled Feasibility Study. JMIR Mhealth Uhealth. 2019 Jul 11;7(7):e12587. doi: 10.2196/12587.
PubMed 31298221
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Iball Mobile Health Technology in Pelvic Floor Muscle Training in the Postpartum Period: a Pilot Mixed Methods Study
- ClinicalTrials.gov ID
- NCT02865954
- Acronym / sponsor ID
- iball / iball_McMaster
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 15 Aug 2016 (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.
he postpartum period is vulnerable to dysfunction of the pelvic floor musculature, which is associated with incontinence, pain, reduced stability of the core and functional deficits. The Society of Obstetricians and Gynaecologists of Canada recommends instruction on the correct performance of pelvic floor muscle exercises, commonly known as Kegels, as standard care. However, only a small proportion of women seek medical care for incontinence in Canada. Recently, there has been an influx of mobile Health technology applications marketed for pelvic floor restoration and fitness that have not been studied. The existence of mHealth technologies may represent an innovative mode to support pelvic health, however systematic exploration to substantiate claims and proposed benefit is required. This pilot study aims to understand the utility of a new mobile health application, iball, as a rehabilitation tool to promote optimal pelvic floor function and to correct pregnancy related pelvic floor dysfunction. The iball is comprised of a device and a mobile app, and it has been brought to market in Europe as a consumer product. The study aims to assess the acceptability, feasibility, and effectiveness of the iball as a pelvic floor muscle training intervention, in comparison to standard care.
Detailed description
Participants would be recruited through three midwifery practices: 1) The Hamilton Midwives; 2) Burlington \& Area Midwives Inc.; and 3) Community Midwives of Halton. Women in the third trimester of their first pregnancy, presenting at these sites will be invited to participate. The goal is to enrol a heterogeneous sample of pregnant women in the Hamilton-Halton region.
A two-step strategy will be used to recruit study participants. First, recruiting sites will attend an information session related to the study. Recruitment posters with tear-off tabs containing the study email (iballstudy@gmail.com) will be posted at the sites. Interested participants will contact the study co-ordinator. Over the phone, the study co-ordinator will determine that the patient is eligible, review the letter of information with the patient, and schedule them for a baseline assessment at approximately 6-weeks post-partum. The letter of information will be emailed to the patient so that they may follow along during the review. All Internet transmission will be performed on campus through MacSecure, or performed off campus through a Virtual Private Network (VPN) provided by McMaster University.
The patient will provide informed, written consent at the baseline appointment and prior to the assessment.
The study compares a 16-week iball pelvic floor training protocol to a 16-week standard care regimen. Sixty participants will be recruited and randomly assigned to the standard care (control) group or the iball intervention group. All participants will meet with an assessor (Dr. Sinead Dufour or Dr. Donna Fedorkow) to undergo a pre-and a post-intervention assessment. Each assessment (30min) will consist of a (15min) internal pelvic exam, following the PERFECT criteria, and two (15min) self-report questionnaires, the Urogenital Distress Inventory-Short Form (UDI-6) and the Incontinence Impact Questionnaire-Short Form (IIQ-7). The pre-study assessment will take place approximately 6 weeks post-partum. The post-study assessment will take place at the end of the 16-week study period. At 8 weeks, midway through the intervention period, all participants will be emailed by the study co-ordinator as a means to provide any support that might be needed.
At the pre-study assessment, the standard care group will receive instructions on how to perform a correct pelvic floor contraction through a digital pelvic examination. In addition to receiving the same standard care instructions, the iball intervention group will undergo a training session (15min) on how to use the iball device and app with the research co-ordinator.
The post-study assessment will require additional time from both groups. The standard care group will answer three self-administered close-ended questions (5min). In addition to answering two of the three close-ended questions (5min), the intervention group will also participate in a semi-structured interview (30min) with the research assistant either in-person or over the phone, depending on the participant's preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iball intervention | Experimental | Device: iball (mhealth application)Use of iball pelvic floor training mhealth application for 16 weeks. |
| Standard Care | No intervention | –Standard Care - control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women in their third trimester, first pregnancy.
Key exclusion criteria (1 listed)
- Currently seeing a pelvic health physiotherapists or participating in a pelvic floor fitness program.
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 |
|---|---|---|
| iball (mhealth application)mhealth application and associated device to support activation of the pelvic floor muscles. | Device | iball intervention |
Primary outcome
Acceptability of the iball intervention (via qualitative data collection)
Time frame: 16 weeks
1. Tell me about your experiences using the iball device? 2. What aspects of iball were the most useful or helpful? 3. Which aspects of iball were least useful or helpful? 4. Are there any changes you would make to the iball device or app? 5. If you had to explain iball to friend, what would you say? 6. Would you recommend it to a friend - why or why not? 7. Do you plan on continuing to use iball at this time? Why or why not? 8. Would you consider using iball again in the future?
3 secondary outcomes
PERFECT - pelvic floor exam scores
Time frame: 16 weeks
Urinary Distress Inventory (UDI-6)
Time frame: 16 weeks
Incontinence Impact Questionnaire (IIQ-7)
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Derived from this study: PubMed 32378735Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
- Derived from this study: PubMed 31298221Dufour S, Fedorkow D, Kun J, Deng SX, Fang Q. Exploring the Impact of a Mobile Health Solution for Postpartum Pelvic Floor Muscle Training: Pilot Randomized Controlled Feasibility Study. JMIR Mhealth Uhealth. 2019 Jul 11;7(7):e12587. doi: 10.2196/12587.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing iball (mhealth application) in people with Segmental Dysfunction of the Pelvic Region, run by McMaster University.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Acceptability of the iball intervention (via qualitative data collection) (time frame: 16 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 NCT02865954, which also lists 2 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 17 Aug 2018.