Digital Care Programs for Female Pelvic Health

Part of paid clinical trials in Draper, Utah.

Sponsor
Sword Health, SA
Study ID
NCT05513417
Status
Enrolling By Invitation

Conditions

  • Pelvic Floor Disorders
  • Pelvic Floor Muscle Weakness
  • Pelvic Organ Prolapse
  • Pelvic Pain
  • Pelvic Pain Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Bloom Pod — DEVICE
    Pelvic floor program consisting of exercise performed while using the device, education and behavioural change

Study Details

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 Dates

Start date
Aug 29, 2022
Status verified
Dec 2024
Primary completion
Aug 31, 2032
Completion
Dec 31, 2032

Study Design

Enrollment
50,000 participants (estimated)

Arms

  • Arm: 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.

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sword Health IncDraperUtah84020-

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