Digital Care Programs for Female Pelvic Health

NCT05513417 | Enrolling By Invitation

• 1 other identifier: BL-OBS-PH-US-01
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment

Secondary Outcomes (7)

• Anxiety

  aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment

• Depression

  aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment

• Work productivity and absenteeism

  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

  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

  aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment

Other Outcomes (4)

• Sessions performed

  Measured at the end of the program, an average of 10 weeks

• Self-reported satisfaction

  aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment

• Total treatment time

  Measured at the end of the program, an average of 10 weeks

Study Arms (1)

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.

Device: Bloom Pod

Interventions

Bloom Pod DEVICE

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

Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

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

Sponsors & Collaborators

• Sword Health, SA: lead

Study Sites (1)

Sword Health Inc

Draper, Utah, 84020, United States

Location

MeSH Terms

Conditions

Pelvic Floor Disorders; Pelvic Pain; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical

Study Officials

• Fernando Correia, PhD

  Sword Health, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 24, 2022
• Study Start: August 29, 2022
• Primary Completion (Estimated): August 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)