Digital Care Programs for Female Pelvic Health (NCT05513417) | Clinical Trial Compass
By InvitationNot Applicable
Digital Care Programs for Female Pelvic Health
United States50,000 participantsStarted 2022-08-29
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 f…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Self-reported symptom level
Timeframe: 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
2
Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7)
Timeframe: Baseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment