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

Urinary Incontinence Clinical Trial

Official title:

Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.: A Noninferiority Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194462
• Other study ID #: POUT/IRB00297309
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Contact: AHN Clinical Trials
• Phone: 412-330-6151
• Email: clinicaltrials[@]ahn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Pelvic Floor Disorders
• Urinary Incontinence

Intervention

Device:
• Pericoach® 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 .

Other:
• Pelvic Floor Physical Therapy
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.

Locations

Country	Name	City	State
United States	AHN Forbes Hospital	Monroeville	Pennsylvania
United States	West Penn Hospital	Pittsburgh	Pennsylvania
United States	AHN Wexford Hospital	Wexford	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	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	12 months
Secondary	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	3 months
Secondary	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	12 months
Secondary	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	3 months
Secondary	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	12 months
Secondary	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	3 months
Secondary	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	12 months