Clinical Trials in the USA / NCT05513417
Enrolling by invitation
Observational
Digital Care Programs for Female Pelvic Health
NCT05513417 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Pelvic Floor DisordersPelvic PainPelvic Organ ProlapsePelvic Floor Muscle WeaknessPelvic Pain Syndrome
Investigational drug(s) / intervention(s)
Bloom Pod
Bloom Pod: Pelvic floor program consisting of exercise performed while using the device, education and behavioural change
Study 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.
Eligibility
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
Primary outcome measure(s)
- Self-reported symptom level — 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
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. - Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7) — Baseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Sword Health Inc | Draper | Utah |
More Sword Health, SA trials in the USA
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05513417 on ClinicalTrials.gov ↗ ← All trials in the USA