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

Not Applicable

Active, not recruiting

• Conditions: Urinary Incontinence; Pelvic Floor Disorders
• Interventions: Device: Pericoach® by Analytica; Other: Pelvic Floor Physical Therapy

• Registration Number: NCT05194462
• Lead Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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.

Study Timeline

• Study First Submitted: 2021-09-19
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-18
• Study Start: 2024-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback device	Pericoach® by Analytica	Pericoach® by Analytica is a vaginal device with recommendation for daily use during the 12 week period.
Pelvic Floor Physical Therapy (PFPT)	Pelvic Floor Physical Therapy	6 sessions of PFPT over a 12 week period with planned home exercises as per physical therapist's recommendation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 the patient impression of symptom improvement using validated questionnaire	12 months	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
Determine overall pelvic floor symptoms measured by validated questionnaire	12 months	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
Determine changes in sexual function following intervention measured by validated questionnaire	12 months	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

Trial Locations

Locations (3)

AHN Forbes Hospital; 🇺🇸 Monroeville, Pennsylvania, United States

West Penn Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

AHN Wexford Hospital; 🇺🇸 Wexford, Pennsylvania, United States