Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.

Study Overview
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Brief Summary
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Pelvic floor dysfunction is commonly seen in the postpartum women with symptoms including urinary urgency and frequency, urinary incontinence and fecal incontinence. Pelvic floor physical therapy (PFPT) and home biofeedback devices have been shown to improve pelvic floor symptoms in postpartum and non-postpartum populations, respectively. This randomized noninferiority clinical trial will assess urinary incontinence-related quality of life in postpartum women with self-reported urinary incontinence who are randomized to a program of home biofeedback or pelvic floor physical therapy.

Detailed Description
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The objective of this proposal is to determine if home biofeedback devices are noninferior to pelvic floor physical therapy for the treatment of postpartum urinary incontinence through a randomized noninferiority clinical trial. The hypothesis is that both interventions will improve incontinence-related quality of life and that home biofeedback will be noninferior to PFPT. Two specific aims will be investigated: 1) Determine the impact of both interventions on urinary incontinence-related quality of life measured by the change in score at 3-months on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF); 2) Determine patient impression of symptoms improvement (measured by the change in score at 3-months and 1-year on the Patient Global Impression of Improvement scale or PGI-I), overall pelvic floor symptoms (measured by the change in score at 3-months and 1-year on the Pelvic Floor Distress Inventory of PFDI) and changes in sexual function (measured by a change in score at 3-months and 1-year in the Female Sexual Function Index or FSFI). An additional exploratory aim will be to observe the change in pelvic floor symptoms in the postpartum period at 3-months and 1-year among a cohort of women who elect for the standard of care without PFPT or biofeedback.

Official Title
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Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.: A Noninferiority Randomized Controlled Trial

Conditions
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Urinary Incontinence, Pelvic Floor Disorders

Intervention / Treatment
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* Device: Pericoach® by Analytica
* Other: Pelvic Floor Physical Therapy
* Other: Questionnaires-No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: following a vaginal delivery (primiparous or multiparous, spontaneous, forceps, or vacuum assisted) willingness to participate in PFPT or home biofeedback exercises access to a smartphone with Bluetooth capabilities positive screen for urinary incontinence between 4 and 8 weeks postpartum defined as patient report of any urinary leakage within the prior two weeks Exclusion Criteria: multiple births or deliver at ≤34 weeks previous urinary incontinence or pelvic organ prolapse surgery self-identified pre-pregnancy pelvic floor disorder such as urinary incontinence fecal incontinence or chronic pelvic pain or if they have a history of prior PFPT

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pelvic Floor Physical Therapy (PFPT)<br>6 sessions of PFPT over a 12 week period with planned home exercises as per physical therapist's recommendation. | Other: Pelvic Floor Physical Therapy<br>* This intervention will assess urinary incontinence-related quality of life in postpartum women with self-reported urinary incontinence who are randomized to a program of PFPT.<br>|
| Active Comparator: Biofeedback device<br>Pericoach® by Analytica is a vaginal device with recommendation for daily use during the 12 week period. | Device: Pericoach® by Analytica<br>* This intervention will assess urinary incontinence-related quality of life in postpartum women with self-reported urinary incontinence who are randomized to a program of home biofeedback .<br>|
| Other: Comparator<br>Women who decline randomization but agree to participate in the comparator arm will be asked to complete the questionnaires at baseline, 3-months and 1-year. They will have no in-person follow up or intervention and will receive the usual postpartum care as determined by their obstetrician. | Other: Questionnaires-No Intervention<br>* Women who decline randomization but agree to participate in the comparator arm will be asked to complete the questionnaires at baseline, 3-months and 1-year. They will have no in-person follow up or intervention and will receive the usual postpartum care as determined by their obstetrician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire | Measured by the change in score on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) between baseline and 3 months; scored between 0 and 21 with higher score meaning larger symptom burden | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire | Measured by the change in score on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) between baseline and 12 months; scored between 0 and 21 with higher score meaning larger symptom burden | 12 months | 
| Determine overall pelvic floor symptoms measured by validated questionnaire | Measured by change in score on the Pelvic Floor Distress Inventory (PFD-I) between baseline and 3 months; scored between 0 and 300 with higher score indicating greater symptom burden | 3 months | 
| Determine overall pelvic floor symptoms measured by validated questionnaire | Measured by change in score on the Pelvic Floor Distress Inventory (PFD-I) between baseline and 12 months; scored between 0 and 300 with higher score indicating greater symptom burden | 12 months | 
| Determine changes in sexual function following intervention measured by validated questionnaire | Measured by change in score on the Female Sexual Function Index (FSFI) between baseline and 3 months; scored between 2 and 36 with a lower score indicating more sexual dysfunction | 3 months | 
| Determine changes in sexual function following intervention measured by validated questionnaire | Measured by change in score on the Female Sexual Function Index (FSFI) between baseline and 12 months; scored between 2 and 36 with a lower score indicating more sexual dysfunction | 12 months | 
| Determine the patient impression of symptom improvement using validated questionnaire | Measured by the change in score on the Patient Global Impression of Improvement (PGI-I) between baseline and 3 months; scored between 1 and 7 with higher scoring meaning worsening symptoms | 3 months | 
| Determine the patient impression of symptom improvement using validated questionnaire | Measured by the change in score on the Patient Global Impression of Improvement (PGI-I) between baseline and 12 months; scored between 1 and 7 with higher scoring meaning worsening symptoms | 12 months |