Iball & Pelvic Floor Muscle Training

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Use of Iball Mobile Health Technology in Pelvic Floor Muscle Training in the Postpartum Period: a Pilot Mixed Methods Study

Conditions
-----------------
Segmental Dysfunction of the Pelvic Region

Intervention / Treatment
-----------------
* Device: iball (mhealth application)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women in their third trimester, first pregnancy. Exclusion Criteria: Currently seeing a pelvic health physiotherapists or participating in a pelvic floor fitness program.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iball intervention<br>Use of iball pelvic floor training mhealth application for 16 weeks. | Device: iball (mhealth application)<br>* mhealth application and associated device to support activation of the pelvic floor muscles.<br>|
| No Intervention: Standard Care<br>Standard Care - control group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PERFECT - pelvic floor exam scores |  | 16 weeks | 
| Urinary Distress Inventory (UDI-6) | Standardized outcome measure | 16 weeks | 
| Incontinence Impact Questionnaire (IIQ-7) | Standardized outcome measure | 16 weeks |