Urinary IncontinenceNCT05194462
Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.
A study testing Pericoach® by Analytica and Pelvic Floor Physical Therapy in people with Urinary Incontinence and Pelvic Floor Disorders, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Pelvic Floor Disorders
- What is being tested?
- Pericoach® by Analytica and Pelvic Floor Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2024to 8 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
AHN Forbes Hospital
Monroeville, Pennsylvania, 15146
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
AHN Wexford Hospital
Wexford, Pennsylvania, 15090
About this study
Official title: Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.: A Noninferiority Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Urinary Incontinence, Pelvic Floor Disorders
- Being tested
- Pericoach® by Analytica, Pelvic Floor Physical Therapy
- Medical subject headings
- Urinary Incontinence, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericoach® by AnalyticaDevice
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 .
Pelvic Floor Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Physical Therapy (PFPT) | Active comparator | 6 sessions of PFPT over a 12 week period with planned home exercises as per physical therapist's recommendation. Receives: Other: Pelvic Floor Physical Therapy |
| Biofeedback device | Active comparator | Pericoach® by Analytica is a vaginal device with recommendation for daily use during the 12 week period. Receives: Device: Pericoach® by Analytica |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (7)
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
Measured: 12 months
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
Measured: 3 months
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
Measured: 12 months
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
Measured: 3 months
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
Measured: 12 months
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
Measured: 3 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Mar 2024
- Primary completion8 May 2025
- Study completion8 May 2025
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Jessica Sassani, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Jessica Sassani, MD, Principal investigator, Allegheny Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194462
- Sponsor's protocol ID
- POUT/IRB00297309
- Status last verified
- Apr 2025
- First submitted
- 19 Sep 2021
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Results will be published; patient identifiers will not be used in the research publications.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.: A Noninferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05194462
- Acronym / sponsor ID
- POUT/IRB00297309
- Conditions
- Urinary Incontinence, Pelvic Floor Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Physical Therapy (PFPT) | Active comparator | Other: Pelvic Floor Physical Therapy6 sessions of PFPT over a 12 week period with planned home exercises as per physical therapist's recommendation. |
| Biofeedback device | Active comparator | Device: Pericoach® by AnalyticaPericoach® by Analytica is a vaginal device with recommendation for daily use during the 12 week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pericoach® by AnalyticaThis 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 . | Device | Biofeedback device |
| Pelvic Floor Physical TherapyThis 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. | Other | Pelvic Floor Physical Therapy (PFPT) |
Primary outcome
Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire
Time frame: 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
7 secondary outcomes
Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire
Time frame: 12 months
Determine overall pelvic floor symptoms measured by validated questionnaire
Time frame: 3 months
Determine overall pelvic floor symptoms measured by validated questionnaire
Time frame: 12 months
Determine changes in sexual function following intervention measured by validated questionnaire
Time frame: 3 months
Determine changes in sexual function following intervention measured by validated questionnaire
Time frame: 12 months
Determine the patient impression of symptom improvement using validated questionnaire
Time frame: 3 months
Determine the patient impression of symptom improvement using validated questionnaire
Time frame: 12 months
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No. Results will be published; patient identifiers will not be used in the research publications.
Related trials for Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
Urinary Incontinence (UI)
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Sassani, MD principal investigator
Allegheny Health Network
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericoach® by Analytica and Pelvic Floor Physical Therapy in people with Urinary Incontinence and Pelvic Floor Disorders, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.