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

Allegheny Health Network (AHN)

Status: Terminated

Conditions: Pelvic Floor Disorders; Urinary Incontinence

Treatments: Device: Pericoach® by Analytica; Other: Pelvic Floor Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05194462

POUT/IRB00297309

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Pelvic Floor Physical Therapy (PFPT)

Active Comparator group

Description:

6 sessions of PFPT over a 12 week period with planned home exercises as per physical therapist's recommendation.

Treatment:

Other: Pelvic Floor Physical Therapy

Biofeedback device

Active Comparator group

Description:

Pericoach® by Analytica is a vaginal device with recommendation for daily use during the 12 week period.

Treatment:

Device: Pericoach® by Analytica