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A new model for pelvic floor disorders: a randomised controlled study

Efficacy of a new prevention and treatment model based on a wearable device-mediated supervised pelvic floor muscle training for pelvic floor disorders: a multicentre randomised controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086533
Enrollment
Unknown
Registered
2024-07-04
Start date
2024-08-15
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Stress urinary incontinence

Interventions

Clinic pelvic floor muscle training (Clinic PFMT):receive biofeedback and electrical stimulation pelvic floor muscle training at clinic
Home pelvic floor muscle training (Home PFMT):receive biofeedback and electrical stimulation pelvic floor muscle training at home

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Clinically diagnosed SUI or MUI as the primary problem. We will consider SUI and MUI following the definition recognized by international guidelines; 2.Women aged 18 years or older.

Exclusion criteria

Exclusion criteria: 1.Pelvic organ prolapse of more than II degree (extrinsic hymen > 1cm); 2.Only urge incontinence was present; 3.Patients with overflow urinary incontinence due to obstruction of the output tract; 4.Patients with urinary incontinence due to ectopic urethra (e.g., urinary fistula); 5.Perineal tear above degree III; 6.Perineal area, urinary system, vagina, anorectal damage or inflammation; 7.History of pelvic floor surgery; 8.Pelvic malignancy; 9.Pelvic floor muscle exercise under formal training within the past 5 years; 10.Pacemaker carriers or other serious medical conditions are not suitable for clinical trials, including: coagulation disorders, severe heart, liver and kidney failure; 11.Patients with severe upper urinary tract obstruction and pelvic floor peripheral nerve conduction obstruction; 12.Other factors influencing trial participation: frequent travel; Mental illness; Unable to voluntarily contract pelvic floor muscles, refusing to place pressure gauges in the vagina, etc; 13.Women who plan to become pregnant, are pregnant or had delivered within the previous 6 weeks; 14.Presence of pelvic floor pain as the primary problem including chronic pelvic pain, pelvic floor myofascial pain syndrome and excessive pelvic floor muscle tone.

Design outcomes

Primary

MeasureTime frame
International Consultation on Incontinence Questionnaire-Urinary Incontinence short form (ICIQ-UI SF;Modifed Oxford scale;

Secondary

MeasureTime frame
Pelvic Organ Prolapse Symptom Score (POP-SS) questionnaire;POP stage;incontinence impact questionnaire short form;patient-completed Short-form Prolapse Incontinence Sexual Questionnaire Incontinence (PISQ-12);maximum voluntary contraction pressure;Broome pelvic muscle self-efficacy scale;Patient adherence to treatment;Clinical cure and improvement rates;Subjective perception of treatment efficacy;

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