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

Primary Purpose

Urinary Incontinence, Pelvic Floor Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pericoach® by Analytica
Pelvic Floor Physical Therapy
Questionnaires-No Intervention
Sponsored by
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • West Penn Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Pelvic Floor Physical Therapy (PFPT)

Biofeedback device

Comparator

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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
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

Full Information

First Posted
September 19, 2021
Last Updated
August 16, 2023
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05194462
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Pelvic Floor Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pelvic Floor Physical Therapy (PFPT)
Arm Type
Active Comparator
Arm Description
6 sessions of PFPT over a 12 week period with planned home exercises as per physical therapist's recommendation.
Arm Title
Biofeedback device
Arm Type
Active Comparator
Arm Description
Pericoach® by Analytica is a vaginal device with recommendation for daily use during the 12 week period.
Arm Title
Comparator
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pericoach® by Analytica
Intervention Description
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 .
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Physical Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaires-No Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire
Description
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
Time Frame
12 months
Title
Determine overall pelvic floor symptoms measured by validated questionnaire
Description
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
Time Frame
3 months
Title
Determine overall pelvic floor symptoms measured by validated questionnaire
Description
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
Time Frame
12 months
Title
Determine changes in sexual function following intervention measured by validated questionnaire
Description
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
Time Frame
3 months
Title
Determine changes in sexual function following intervention measured by validated questionnaire
Description
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
Time Frame
12 months
Title
Determine the patient impression of symptom improvement using validated questionnaire
Description
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
Time Frame
3 months
Title
Determine the patient impression of symptom improvement using validated questionnaire
Description
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
Time Frame
12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women age 18 of greater following a vaginal delivery.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AHN Clinical Trials
Phone
412-330-6151
Email
clinicaltrials@ahn.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline Noel
Phone
412-578-1646
Email
Jacqueline.Noel@AHN.ORG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Sassani, MD
Organizational Affiliation
Allegheny Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AHN Clinical Trials
Phone
412-330-6151
Email
clinicaltrials@ahn.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will be published; patient identifiers will not be used in the research publications.

Learn more about this trial

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

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