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Short-term Pudendal Nerve Electrical Stimulation for Refractory Perineal Pain: A Clinical Study

Short-term Pudendal Nerve Electrical Stimulation for Refractory Perineal Pain: A Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119962
Enrollment
Unknown
Registered
2026-03-06
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

Pudendal neuralgia

Interventions

Pudendal nerve pulsed radiofrequency group (PRF group):Pudendal nerve pulsed radiofrequency
Pudendal nerve electrical stimulation group (PNS group):Pudendal nerve electrical stimulation

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 80 years; 2. Diagnosis of pudendal neuralgia meets the Nantes criteria, with the main criteria including: (1) Pain located in the distribution area of the pudendal nerve; (2) Pain worsens when sitting; (3) Pain does not wake the patient at night; (4) No associated sensory loss; (5) Pudendal nerve diagnostic block is effective (pain relief >=50%); 3. Conservative treatment for more than 3 months (e.g., pelvic floor rehabilitation, oral medications such as gabapentin, pregabalin, duloxetine, fluphenazine, clonazepam, etc.; pudendal nerve injection therapy, etc.) and poor response to conservative treatment or intolerance to drug side effects; 4. Ability to sign an informed consent form;

Exclusion criteria

Exclusion criteria: 1.Pain attributable to pelvic malignancy or autoimmune disease; 2.Pain resulting from prior pelvic surgery; 3.Current anticoagulant therapy or coagulation disorder; 4.Pregnancy; 5.Local or systemic infection; 6.Poorly controlled diabetes mellitus; 7.Inability to complete questionnaire assessments;

Design outcomes

Primary

MeasureTime frame
Pain relief response rate;

Secondary

MeasureTime frame
Overall surgical satisfaction;Pudendal neurophysiology: bulbocavernosus reflex and pudendal somatosensory evoked potentials;Factors influencing surgical outcomes;Analgesic usage;Neuroinflammation;Complications;

Countries

China

Contacts

Public ContactLiu Yiming

Peking University People's Hospital

liuyiming1984@163.com+86 10 8832 5206

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026