An observational study in Pelvic Floor Disorders, Pelvic Pain and Pelvic Organ Prolapse, sponsored by Sword Health, SA. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Sword Health, SA · Observational
Among 61 studies in Pelvic Floor Disorders with a site in United States — 12 open to participants now, 16 under way, none of them phase 3. Pelvic Floor Disorders · United States.
Among the 61 studies in Pelvic Floor Disorders with a site in United States, this one has the largest planned enrollment of the 11 observational ones, is one of 2 that started in 2022, is one of 11 observational ones, reaches primary completion later than 15 of the 15 other live ones, and was the 42nd registered.
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
This study's planned enrollment of 50,000 is above the median of 161 across 60 observational studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →12 of the 61 studies in Pelvic Floor Disorders with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 27 Pelvic Floor Disorders studies recruiting now, 17 (63%) set no upper age limit and 10 (37%) stop at 75 or younger; 0 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 99 Years · female · healthy volunteers too.
The full table on the hub →61 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 2 started in 2022.
Median enrollment 57 across the 50 interventional studies, 133 across the 11 observational. Of the 38 that completed or were terminated, 15 (39%) have results posted.
11 of 61 have an industry lead sponsor. The 10 most frequent:
Sword Health, SA is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
Sword Health, SA has 1 study filed under Pelvic Floor Disorders — fewer than ten, so there is no comparison to draw.
8 of the studies in Pelvic Floor Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07387315TriHealth Inc.A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections | 2026-11 |
| NCT06689891Yale UniversityVideo-Based Pelvic Floor Muscle Therapy | 2026-12 |
| NCT06111209Brigham and Women's HospitalThe Anabolic Effect of Testosterone on Pelvic Floor Muscles | 2026-12-31 |
| NCT06796985University of MiamiBotox for Chronic Pelvic Pain | 2027-03-22 |
| NCT06798311University of ChicagoReducing Disparities in Urinary Control Symptoms for Minority Women | 2027-05 |
Among the 61 studies in Pelvic Floor Disorders with a site in United States, from their registry updates:
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.
This patient registry was designed as 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 data will allow the researchers to:
The primary outcome will be the evolution of the participant's condition along the program. Depending on the condition, primary and secondary outcome measures vary, but the registry will include, in all cases, a complete characterisation of the participant's pelvic health status, as well as the periodic assessment of: a) performance indicators (through condition-specific tests); b) patient-reported outcomes (obtained using internationally validated pathology-specific questionnaires); c) pain levels; d) compliance; e) patient satisfaction
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Pelvic floor program consisting of exercise performed while using the device, education and behavioural change
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.
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
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.
Time frame: Baseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Anxiety
Change over time common to all conditions measured through General Anxiety Disorder-7 (GAD-7) is a 7-item scale (scores 0-21). Higher scores mean higher anxiety levels.
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Depression
Change over time common to all conditions measured through Patient Health Questionnaire-9 (PHQ-9), a 9-item scale (0-27). Higher scores mean higher depression levels.
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Work productivity and absenteeism
Change over time common to all conditions measured through Work Productivity and Activity Impairment Questionnaire (WPAI) assessed by the sub-scores: WPAI overall (combining presenteeism and absenteeism), WPAI work (presenteeism), WPAI time (absenteeism) and WPAI activities (activities of daily living impairment) (scores 0-100%). Higher scores mean greater impairment.
Time frame: 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
Change over time common to all conditions measured through Self-reported consumption of painkillers (yes/no); Prescription drugs (yes/no); Opioids (yes/no)
Time frame: 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
Change over time common to all conditions measured through a numerical rating scale (0-100). Higher scores mean higher intent.
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported fatigue (VAS)
Change over time common to all conditions measured through a 0-10 Visual Analogue Scale. Higher scores mean higher fatigue.
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported symptom level (VAS)
Change over time common to all conditions measured through a 0-10 Visual Analogue Scale. Higher scores mean more symptoms.
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Sessions performed
Number of total exercise sessions performed
Time frame: Measured at the end of the program, an average of 10 weeks
Self-reported satisfaction
measured through the Net Promoter Score question collected at end of program: "On a scale from 0 to 10, how likely are you to recommend SWORD's programs to a friend or family member?")
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Total treatment time
Number of minutes spent on exercise sessions (aggregated)
Time frame: Measured at the end of the program, an average of 10 weeks
Average treatment time per week
Average number of minutes spent on exercise per week
Time frame: Measured at the end of the program, an average of 10 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for Aug 2032, 120 months after the start.
Of 26 observational studies under Pelvic Floor Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 45. This study's planned 120 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Sword Health, SA