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Real world cross-sectional survey and efficacy follow-up study of domestic household female pelvic floor rehabilitation device

Real world cross-sectional survey and efficacy follow-up study of domestic household female pelvic floor rehabilitation device

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094618
Enrollment
Unknown
Registered
2024-12-25
Start date
2024-12-29
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pelvic floor dysfunction

Interventions

Case series:None

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1.Female users registered to use the Dayue Home Pelvic Floor Muscle Treatment Device from December 2022 to November 2024; 2.Age >= 18 years old; 3.Users who have completed 15 sessions of pelvic floor muscle strength assessment using the pelvic floor muscle therapy device for the first time, with a 90 day extension from the expected date (intervention period);

Exclusion criteria

Exclusion criteria: 1.Non active users: No treatment records within 12 months; 2.Refusal to participate in research; 3.Asexual life history; 4.Spasmodic paralysis, limb joint contracture deformity; 5.Patients using implantable metal or electronic devices (such as pacemakers); 6.Individuals who have undergone pelvic floor surgery within the first six months prior to registering for the use of the Dayue Pelvic Floor Muscle Therapy Device, as well as those with serious illnesses or frailty (such as those with malignant tumors, severe liver, liver, and kidney failure, spasticity after a cerebrovascular accident, heart disease patients, etc.); 7.Users with certain neurological disorders (such as complete denervation of pelvic floor muscles, dementia, abscess), drug-induced neurological disorders, severe cognitive impairment, unclear consciousness, and inability to actively cooperate with treatment;

Design outcomes

Primary

MeasureTime frame
Patient General Health Improvement Questionnaire (PGI-I);

Secondary

MeasureTime frame
Pelvic floor electromyography assessment;Summary score of the International Urinary Incontinence Advisory Committee Urinary Incontinence Questionnaire (ICIQ-UI-SF);Vaginal laxity questionnaire (VLQ);

Countries

China

Contacts

Public ContactZhijing Sun

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

sunzhj2001@sina.com+86 10 69156204

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026