Pelvic Floor DisordersNCT05513417
Digital Care Programs for Female Pelvic Health
An observational study of Pelvic Floor Disorders and Pelvic Pain, run by Sword Health, SA at 1 site in United States.
Trial summary
The purpose of this study is to create a research repository, composed of data collected in the course of digital care programs for pelvic health conditions by SWORD Health/Bloom to individuals undergoing those programs. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Pelvic Pain, Pelvic Organ Prolapse
- What is being tested?
- Bloom Pod
- Type of treatment
- Medical device
- How many people
- 50,000 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2022to Dec 2032
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: These programs will cover patients suffering from pain and/or activity limitations in relation to the pelvic musculoskeletal systems, including but not limited to, pain/limitations affecting neuromusculoskeletal, genitourinary, gastrointestinal, and reproductive systems in this region. The programs will also cover patients submitted to surgery for a given pelvic condition involving any of the aforementioned systems.
Who may be able to join
- Over 18 years old;
- Signs/symptoms consistent with an acute (<12 weeks) or chronic (>12 weeks) abdominopelvic condition without signs/symptoms indicating underlying disease states that require immediate referral for medical management OR recovering from pelvic surgery with indication from their surgeon to engage in a pelvic physical therapy program
- Able to understand study procedures and willing to provide informed consent.
Who cannot join
- Health condition (cardiac, respiratory, neurological, immune) condition incompatible with at least 20 minutes of light to moderate exercise if not cleared by a physician to engage in an exercise program
- Bone fractures or other musculoskeletal conditions in which mobilization of the segment or joint is contra-indicated
- Rapidly progressive and new in onset neurological complaints if not cleared by a physician to engage in an exercise program; or signs of acute, serious neurologic compromise
- Active cancer diagnosis or receiving treatment for cancer if not cleared by a physician to engage in an exercise program
- Signs/symptoms consistent with inflammatory bowel diseases (Crohn's, ulcerative colitis, etc.)
- Signs/symptoms consistent with an active pelvic infection
Show all 11Show fewer
- Aphasia, dementia or any other psychiatric comorbidity that interferes with the use of the medical device
- Complicated or high-risk pregnancy
- Hemodynamic instability
- Significant trauma to the area of pain within the last 12 weeks and functional incapacity and not cleared by a physician to engage in an exercise program
- Surgery within the last 12 weeks and not cleared by a physician to engage in an exercise program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Digital Care Programs for Female Pelvic Health: a Large-scale, Multi-disorder, Observational Study
The purpose of this study is to create a research repository, composed of data collected in the course of digital care programs for pelvic health conditions by SWORD Health/Bloom to individuals undergoing those programs.
This will allow the investigators to observe the acceptance, engagement and outcomes of programs using this approach in the treatment of multiple pelvic health disorders.
Read the detailed description
This patient registry was designed as a research repository, composed of data collected in the course of digital care programs for pelvic health conditions by SWORD Health/Bloom to individuals undergoing those programs.
This data will allow the researchers to:
- Assess the adoption, engagement and feasibility of digital care programs for pelvic musculoskeletal disorders and pelvic health;
- Assess the results of digital care programs and compare the costs with the benefits obtained;
- Correlate the results with patient's demographic and clinical profiles;
- Examine the impact of mental health and the behavioral modification components of Bloom's interventions on disease markers, comorbidities, and productivity;
- Increase the knowledge on several pelvic musculoskeletal disorders, namely how they progress and respond to digital care programs;
- Develop new or improved tools to assist clinicians in the management of these disorders and in helping people achieve better pelvic health
The primary outcome will be the evolution of the participant's condition along the program. Depending on the condition, primary and secondary outcome measures vary, but the registry will include, in all cases, a complete characterisation of the participant's pelvic health status, as well as the periodic assessment of: a) performance indicators (through condition-specific tests); b) patient-reported outcomes (obtained using internationally validated pathology-specific questionnaires); c) pain levels; d) compliance; e) patient satisfaction
- Conditions
- Pelvic Floor Disorders, Pelvic Pain, Pelvic Organ Prolapse, Pelvic Floor Muscle Weakness, Pelvic Pain Syndrome
- Being tested
- Bloom Pod
- Medical subject headings
- Pelvic Floor Disorders, Pelvic Pain, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bloom PodDevice
Pelvic floor program consisting of exercise performed while using the device, education and behavioural change
| Study group | Role | What they receive |
|---|---|---|
| Intervention | These programs will cover participants with pelvic floor conditions which significantly impact their quality of life, to the extent they seek specialised care in direct relation to these conditions. Receives: Device: Bloom Pod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported symptom level
Change over time in clinical outcomes common to all conditions measured through a 0-10 Pain Numerical Rating Scale referring to the previous 7 days. Higher scores mean more symptoms.
Measured: Baseline, and then at regular intervals (after 9, 15 and 30 sessions) after program initiation, and then at 6, 12 and 24 months after enrolment
Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7)
The PFIQ-7 consists of 7 questions that need to be answered 3 times each considering symptoms related to the bladder or urine, vagina or pelvis, and bowel or rectum and their effect on function, social health, and mental health in the past 3 months. The responses for each question range from "not at all" (0) to "quite a bit" (3). To get scale scores, the mean of each of the 3 scales is individually calculated, which ranges from 0-3, this number is then multiplied by 100 and then divided by 3. The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.
Measured: Baseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Secondary outcomes (7)
Anxiety
Change over time common to all conditions measured through General Anxiety Disorder-7 (GAD-7) is a 7-item scale (scores 0-21). Higher scores mean higher anxiety levels.
Measured: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Depression
Change over time common to all conditions measured through Patient Health Questionnaire-9 (PHQ-9), a 9-item scale (0-27). Higher scores mean higher depression levels.
Measured: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Work productivity and absenteeism
Change over time common to all conditions measured through Work Productivity and Activity Impairment Questionnaire (WPAI) assessed by the sub-scores: WPAI overall (combining presenteeism and absenteeism), WPAI work (presenteeism), WPAI time (absenteeism) and WPAI activities (activities of daily living impairment) (scores 0-100%). Higher scores mean greater impairment.
Measured: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported consumption of painkillers
Change over time common to all conditions measured through Self-reported consumption of painkillers (yes/no); Prescription drugs (yes/no); Opioids (yes/no)
Measured: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported intent to seek additional healthcare services
Change over time common to all conditions measured through a numerical rating scale (0-100). Higher scores mean higher intent.
Measured: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported fatigue (VAS)
Change over time common to all conditions measured through a 0-10 Visual Analogue Scale. Higher scores mean higher fatigue.
Measured: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported symptom level (VAS)
Change over time common to all conditions measured through a 0-10 Visual Analogue Scale. Higher scores mean more symptoms.
Measured: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start29 Aug 2022
- Primary completionAug 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sword Health, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernando Correia, PhD, Principal investigator, Sword Health, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513417
- Sponsor's protocol ID
- BL-OBS-PH-US-01
- Status last verified
- Dec 2024
- First submitted
- 19 Aug 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pereira AP, Janela D, Areias AC, Molinos M, Tong X, Bento V, Yanamadala V, Atherton J, Dias Correia F, Costa F. Innovating Care for Postmenopausal Women Using a Digital Approach for Pelvic Floor Dysfunctions: Prospective Longitudinal Cohort Study. JMIR Mhealth Uhealth. 2025 Apr 2;13:e68242. doi: 10.2196/68242.
PubMed 40173388
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Care Programs for Female Pelvic Health: a Large-scale, Multi-disorder, Observational Study
- ClinicalTrials.gov ID
- NCT05513417
- Acronym / sponsor ID
- BL-OBS-PH-US-01
- Conditions
- Pelvic Floor Disorders, Pelvic Pain, Pelvic Organ Prolapse, Pelvic Floor Muscle Weakness, Pelvic Pain Syndrome
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Sword Health, SAIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- Aug 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 24 Aug 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.
The purpose of this study is to create a research repository, composed of data collected in the course of digital care programs for pelvic health conditions by SWORD Health/Bloom to individuals undergoing those programs.
This will allow the investigators to observe the acceptance, engagement and outcomes of programs using this approach in the treatment of multiple pelvic health disorders.
Detailed description
This patient registry was designed as a research repository, composed of data collected in the course of digital care programs for pelvic health conditions by SWORD Health/Bloom to individuals undergoing those programs.
This data will allow the researchers to:
- Assess the adoption, engagement and feasibility of digital care programs for pelvic musculoskeletal disorders and pelvic health;
- Assess the results of digital care programs and compare the costs with the benefits obtained;
- Correlate the results with patient's demographic and clinical profiles;
- Examine the impact of mental health and the behavioral modification components of Bloom's interventions on disease markers, comorbidities, and productivity;
- Increase the knowledge on several pelvic musculoskeletal disorders, namely how they progress and respond to digital care programs;
- Develop new or improved tools to assist clinicians in the management of these disorders and in helping people achieve better pelvic health
The primary outcome will be the evolution of the participant's condition along the program. Depending on the condition, primary and secondary outcome measures vary, but the registry will include, in all cases, a complete characterisation of the participant's pelvic health status, as well as the periodic assessment of: a) performance indicators (through condition-specific tests); b) patient-reported outcomes (obtained using internationally validated pathology-specific questionnaires); c) pain levels; d) compliance; e) patient satisfaction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Device: Bloom PodThese programs will cover participants with pelvic floor conditions which significantly impact their quality of life, to the extent they seek specialised care in direct relation to these conditions. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- These programs will cover patients suffering from pain and/or activity limitations in relation to the pelvic musculoskeletal systems, including but not limited to, pain/limitations affecting neuromusculoskeletal, genitourinary, gastrointestinal, and reproductive systems in this region. The programs will also cover patients submitted to surgery for a given pelvic condition involving any of the aforementioned systems.
Key inclusion criteria (3 listed)
- Over 18 years old;
- Signs/symptoms consistent with an acute (<12 weeks) or chronic (>12 weeks) abdominopelvic condition without signs/symptoms indicating underlying disease states that require immediate referral for medical management OR recovering from pelvic surgery with indication from their surgeon to engage in a pelvic physical therapy program
- Able to understand study procedures and willing to provide informed consent.
Key exclusion criteria (11 listed)
- Health condition (cardiac, respiratory, neurological, immune) condition incompatible with at least 20 minutes of light to moderate exercise if not cleared by a physician to engage in an exercise program
- Bone fractures or other musculoskeletal conditions in which mobilization of the segment or joint is contra-indicated
- Rapidly progressive and new in onset neurological complaints if not cleared by a physician to engage in an exercise program; or signs of acute, serious neurologic compromise
- Active cancer diagnosis or receiving treatment for cancer if not cleared by a physician to engage in an exercise program
- Signs/symptoms consistent with inflammatory bowel diseases (Crohn's, ulcerative colitis, etc.)
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 |
|---|---|---|
| Bloom PodPelvic floor program consisting of exercise performed while using the device, education and behavioural change | Device | Intervention |
Primary outcome
Self-reported symptom level
Time frame: Baseline, and then at regular intervals (after 9, 15 and 30 sessions) after program initiation, and then at 6, 12 and 24 months after enrolment
Change over time in clinical outcomes common to all conditions measured through a 0-10 Pain Numerical Rating Scale referring to the previous 7 days. Higher scores mean more symptoms.
Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7)
Time frame: Baseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
The PFIQ-7 consists of 7 questions that need to be answered 3 times each considering symptoms related to the bladder or urine, vagina or pelvis, and bowel or rectum and their effect on function, social health, and mental health in the past 3 months. The responses for each question range from "not at all" (0) to "quite a bit" (3). To get scale scores, the mean of each of the 3 scales is individually calculated, which ranges from 0-3, this number is then multiplied by 100 and then divided by 3. The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.
7 secondary outcomes
Anxiety
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Depression
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Work productivity and absenteeism
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported consumption of painkillers
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported intent to seek additional healthcare services
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported fatigue (VAS)
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported symptom level (VAS)
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 40173388Pereira AP, Janela D, Areias AC, Molinos M, Tong X, Bento V, Yanamadala V, Atherton J, Dias Correia F, Costa F. Innovating Care for Postmenopausal Women Using a Digital Approach for Pelvic Floor Dysfunctions: Prospective Longitudinal Cohort Study. JMIR Mhealth Uhealth. 2025 Apr 2;13:e68242. doi: 10.2196/68242.
- Individual participant dataSharing planned: No
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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.
Fernando Correia, PhD principal investigator
Sword Health, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders and Pelvic Pain, run by Sword Health, SA at 1 site 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 3 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Self-reported symptom level (time frame: Baseline, and then at regular intervals (after 9, 15 and 30 sessions) after program initiation, and then at 6, 12 and 24 months after enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05513417, which also lists 1 linked publication.
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 6 Dec 2024.