Digital Care Programs for Female Pelvic Health

NCT ID: NCT05513417

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 50000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-29
• Study Completion Date: 2032-12-31

Brief 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.

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:

1. Assess the adoption, engagement and feasibility of digital care programs for pelvic musculoskeletal disorders and pelvic health;

2. Assess the results of digital care programs and compare the costs with the benefits obtained;

3. Correlate the results with patient's demographic and clinical profiles;

4. Examine the impact of mental health and the behavioral modification components of Bloom's interventions on disease markers, comorbidities, and productivity;

5. Increase the knowledge on several pelvic musculoskeletal disorders, namely how they progress and respond to digital care programs;

6. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Bloom Pod

Intervention Type: DEVICE

Pelvic floor program consisting of exercise performed while using the device, education and behavioural change

Interventions

Bloom Pod

Pelvic floor program consisting of exercise performed while using the device, education and behavioural change

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sword Health, SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Correia, PhD

Role: PRINCIPAL_INVESTIGATOR

Sword Health, Inc

Locations

Sword Health Inc

Draper, Utah, United States

Countries

United States

Other Identifiers

BL-OBS-PH-US-01

Identifier Type: -

Identifier Source: org_study_id