Digital Care Programs for Female Pelvic Health

Enrolling by invitation

Conditions studied: Pelvic Floor Disorders, Pelvic Pain, Pelvic Organ Prolapse, Pelvic Floor Muscle Weakness, Pelvic Pain Syndrome

In brief

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.

Key facts

Study ID

NCT05513417

Run by

Sword Health, SA

People needed

50000

Starts

2022-08-29

Expected to finish

2032-12-01

Last updated by the study team

2024-12-06

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Sword Health Inc — Draper, Utah, United States

Full record on ClinicalTrials.gov

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