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NCT05513417

Digital Care Programs for Female Pelvic Health

Enrolling by Invitation
Not specifiedAges 18–99Observational
Sword Health, SA
~50,000 participants
Updated 2024-12-06 on ClinicalTrials.gov
What's tested:Bloom Pod

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Self-reported symptom level
Measured over 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
+1 more outcome measured

Conditions

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

Explore related trials

Pelvic Floor DisorderPelvic Floor Muscle WeaknessPelvic Organ ProlapsePelvic Pain

Where it's being run

1 sites across 1 states
Utah1

Study leadership

  • Fernando Correia, PhD · PRINCIPAL_INVESTIGATOR · Sword Health, Inc

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Self-reported symptom levelBaseline, 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.