NCT05513417

Digital Care Programs for Female Pelvic Health

Digital Care Programs for Female Pelvic Health: a Large-scale, Multi-disorder, Observational Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 50,000 (estimated)
• Sponsor: Sword Health, SA · Industry
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Bloom Pod	Pelvic floor program consisting of exercise performed while using the device, education and behavioural change

Timeline

• Start date: 2022-08-29
• Primary completion: 2032-08-01
• Completion: 2032-12-01
• First posted: 2022-08-24
• Last updated: 2024-12-06

Locations

1 site across 1 country: United States