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A non-inferiority clinical study of pudendal nerve stimulation in the treatment of moderate to severe stress urinary incontinence in women

A non-inferiority clinical study of pudendal nerve stimulation in the treatment of moderate to severe stress urinary incontinence in women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098074
Enrollment
Unknown
Registered
2025-03-03
Start date
2025-03-04
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Urinary incontinence

Interventions

Experimental group:Electical pudendal nerve stimulation
Control group:inside-out tension-free vaginal tape - obturator (TVT-O)

Sponsors

Zhejiang Provincial Hospital of TCM
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Mixed urinary incontinence consistent with the diagnosis of SUI or predominantly SUI; 2. Patients with moderate or severe SUI assessed by clinical symptoms; 3. Residual urine volume less than 50 ml; 4. Female patients between the ages of 18-85 years; 5. Normal cognitive level, able to cooperate with the experimental process of this study;

Exclusion criteria

Exclusion criteria: 1. Mixed urinary incontinence with urgency incontinence as the main body; 2. Filling urinary incontinence; 3. Urinary incontinence caused by other diseases, such as Parkinson's disease, multiple sclerosis, spinal cord injury, Alzheimer's disease, diabetes, etc.; 4. Dysuria, urethral stricture, urinary tract obstruction, refractory urinary tract infection, hydronephrosis, urinary stones, tumors; 5. Are taking other related drugs such as selective a1 adrenergic receptor agonists or M receptor antagonists or norepinephrine inhibitors that affect bladder and urethral function; 6. Pregnant and lactating women; 7. Patients with severe heart, lung, liver, kidney and other important organ dysfunction and coagulation dysfunction; 8. Previous history of anti-urinary incontinence surgery or complex urethral surgery, major pelvic surgery or radical pelvic surgery; 9. Presence of a vaginal mass beyond the hymen ring or known pelvic organ prolapse on examination;

Design outcomes

Primary

MeasureTime frame
International Consultation on Incontinence Questionnaire (ICIQ-UI SF) score;Urine leakage of the 1 hour pad test;

Secondary

MeasureTime frame
Electromyography values of pelvic floor muscle;Incontinence Quality of Life (I-QOL) score;

Countries

China

Contacts

Public ContactShan Chen

Zhejiang Provincial Hospital of TCM

breezehilly@hotmail.com+86 571 86919352

Outcome results

None listed

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