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Prospective cohort of home-based pelvic floor rehabilitation device

A real-world prospective cohort study of a home-based pelvic floor rehabilitation device for women

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101182
Enrollment
Unknown
Registered
2025-04-21
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Pelvic floor dysfunction, PFD

Interventions

Stress urinary incontinence:None
Non-stress incontinence:None

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Female users who were newly registered to use the Dayue Home-based pelvic floor muscle rehabilitation device during the prospective enrollment period; 2.aged more than 18 years; 3.not pregnant, more than 6 weeks postpartum, and had no fertility plans during treatment; 4.suffered from pelvic floor dysfunction such as urinary incontinence, overactive bladder, pelvic organ prolapse, vaginal laxity, sexual dysfunction, fecal incontinence, and chronic pelvic pain.

Exclusion criteria

Exclusion criteria: 1. Inability to complete home pelvic floor exercise as planned or refusal to participate in surveys, assessments and follow-ups; 2. No sexual history; 3. Spasmodic paralysis, limb bone and joint contracture deformity; 4. Patients using implantable metal or electronic devices (e.g. pacemakers); 5. Those who have undergone pelvic floor surgery within six months, those who are seriously ill or weak (such as: patients with malignant tumors, severe heart, liver and kidney failure, spasms after cerebrovascular accidents, heart patients, etc.); 6. Users with certain neurological diseases (such as: complete denervation of pelvic floor muscles, dementia, carbuncles), drug-induced neurological disorders, severe cognitive impairment, unconsciousness, and inability to actively cooperate with treatment; 7. Users with certain neurological diseases (such as: complete denervation of pelvic floor muscles, dementia, carbuncles), drug-induced neurological disorders, severe cognitive impairment, unconsciousness, and inability to actively cooperate with treatment.

Design outcomes

Primary

MeasureTime frame
Patient Global Impression of Improvement;

Secondary

MeasureTime frame
International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form;POP Symptom Score questionnaire;Vaginal Laxity Questionnaire;Overactive bladder symptom score;Patient-completed Short-form Prolapse Incontinence Sexual Questionnaire Incontinence;Female Sexual Function Index;Pelvic Floor Impact questionnaire -7;Incontinence Quality of Life Instrument;12-item Short-Form Health Survey;Broome Pelvic Muscle Self-Efficacy Scale;Surface pelvic floor electromyography assessment;

Countries

China

Contacts

Public ContactZhijing Sun

Peking Union Medical College Hospital

sunzhj2001@sina.com+86 10 69156204

Outcome results

None listed

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