Clinical trial NCT05194462: Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.
Official title: Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.: A Noninferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Pelvic Floor Disorders
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2022-01-18
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire
timeFrame: 12 months
measure: Determine overall pelvic floor symptoms measured by validated questionnaire
timeFrame: 3 months
measure: Determine overall pelvic floor symptoms measured by validated questionnaire
timeFrame: 12 months
measure: Determine changes in sexual function following intervention measured by validated questionnaire
timeFrame: 3 months
measure: Determine changes in sexual function following intervention measured by validated questionnaire
timeFrame: 12 months
measure: Determine the patient impression of symptom improvement using validated questionnaire
timeFrame: 3 months
measure: Determine the patient impression of symptom improvement using validated questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Monroeville
country: United States
facility: AHN Forbes Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn Hospital
state: Pennsylvania
city: Wexford
country: United States
facility: AHN Wexford Hospital
state: Pennsylvania
Study officials:
affiliation: Allegheny Health Network
name: Jessica Sassani, MD
role: PRINCIPAL_INVESTIGATOR
References: