Urinary Incontinence, Pelvic Floor Disorders
Conditions
Brief summary
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
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.
Interventions
DEVICEPericoach® by Analytica
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 .
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.
Sponsors
Johns Hopkins University
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire | 12 months | 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 |
| Determine overall pelvic floor symptoms measured by validated questionnaire | 3 months | 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 |
| Determine changes in sexual function following intervention measured by validated questionnaire | 3 months | 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 |
| Determine the patient impression of symptom improvement using validated questionnaire | 3 months | 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 |
Countries
United States
Outcome results
None listed