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A Combined Pelvic Floor Rehabilitation Program for Stress Urinary Incontinence: A Clinical Study

Clinical Study of Pelvic Floor Myofascial Release Combined with Biofeedback Electrical Stimulation in the Treatment of Stress Urinary Incontinence

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128413
Enrollment
Unknown
Registered
2026-07-20
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Stress Urinary Incontinence (SUI)

Interventions

Control group:Pelvic Floor Biofeedback Electrical Stimulation
Intervention group:Pelvic Floor Biofeedback Electrical Stimulation Combined with Pelvic Floor Myofascial Relese

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18–65 years, meeting the clinical diagnostic criteria for female stress urinary incontinence (SUI): chief complaint of involuntary urinary leakage during increased intra-abdominal pressure (e.g., coughing, physical activity) with a disease duration of >= 3 months; 2. A score of >= 3 on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF); 3. Definite signs of pelvic floor myofascial dysfunction: vaginal palpation revealing at least one obvious trigger point in the pelvic floor muscles with local hypertonia or tenderness, and a Numerical Rating Scale (NRS) pain score of >= 3; 4. Urodynamic studies confirming stress urinary incontinence without detrusor overactivity; 5. Patients who are informed of the study details and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with urge urinary incontinence, mixed urinary incontinence, or neurogenic bladder; 2. Patients with severe pelvic organ prolapse (POP-Q stage >= II) or a history of pelvic floor reconstruction, urethral sling surgery, or other related pelvic surgeries; 3. Patients with acute genitourinary tract infection, unexplained vaginal bleeding, malignant tumors, cardiac pacemakers, or metal implants; 4. Patients who have used medications affecting bladder function or muscle tone (e.g., anticholinergics, muscle relaxants) within the past 4 weeks; 5. Patients with cognitive impairment or unable to complete the specified treatment course and follow-up due to personal reasons.

Design outcomes

Primary

MeasureTime frame
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Score;1-h Pad Test;

Secondary

MeasureTime frame
Modified Oxford Scale, MOS;Evaluation of pelvic floor myofascial function;Transvaginal pelvic floor ultrasound;Pelvic floor surface electromyography;Pelvic Organ Prolapse Quantification, POP-Q;Patient Global Impression of Improvement, PGI-I;

Countries

China

Contacts

Public ContactLin Zhang

The First Affiliated Hospital of Soochow University

15951876180@163.com+86 512 67975296

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026