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The role of self-assessment combined with home-based wearable device over supervised pelvic floor muscle training for stress or mixed urinary incontinence in postpartum women: a multi-center randomized controlled trial

The role of self-assessment combined with home-based wearable device over supervised pelvic floor muscle training for stress or mixed urinary incontinence in postpartum women: a multi-center randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052556
Enrollment
Unknown
Registered
2021-10-31
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

female pelvic floor dysfunction

Interventions

experimental group:home-based Wearable Medical Devices supervised PFMT
control group:exercise without device

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Postpartum women (6 weeks <= time to birth <=3 months before enrollment); 2. Clinically diagnosed stress or mixed urinary incontinence as the primary problem; 3. Women aged 18 years or older.

Exclusion criteria

Exclusion criteria: 1. Urgency urinary incontinence alone; 2. A prolapse greater than stage II on examination (>1cm below the hymen on straining); 3. Third and fourth degree perineal tear; 4. Suffering diastasis recti abdominis and chronic pelvic pain as the primary problem need treatment; 5. A history of stress urinary incontinence(SUI) before pregnancy; 6. Had previous pelvic surgery; 7. Malignant pelvic cancer; 8. Genurological infection; 9. Have been trained by pelvic floor rehabilitation therapists in the past 5 years (more than 3 months); 10. Pacemaker carriers or other serious diseases are not suitable for clinical trials; 11. Other factors affecting participation in the experiment: frequent business trips; Mental illness; Unable to voluntarily contract pelvic floor muscles, refused to place pressure gauges in the vagina, etc.

Design outcomes

Primary

MeasureTime frame
ICIQ-SF;

Secondary

MeasureTime frame
I-QOL;POP-SS;BPMSES;PISQ-12;MOS;Vaginal resting pressure;MVCP;The strength of type I muscle fiber;The strength of type II muscle fiber;Pelvic Organ Prolapse Quantification;

Countries

China

Contacts

Public ContactSun Zhijing

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

sunzhj2001@sina.com+86 13651314354

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026