pelvic floor dysfunction
Conditions
Interventions
Experimental Group:Pelvic floor electrostimulation combined with manual massage plus Xiaoyao Granules
Control Group:Pelvic floor electrostimulation combined with manual massage, plus placebo
Sponsors
Obstetrics & Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
20 Years to 55 Years
Inclusion criteria
Inclusion criteria: Diagnostic Criteria for NPFD Western Medicine Diagnostic Criteria: 1) Pelvic pain lasting >3 months 2) Lower urinary tract symptoms: frequency urgency incomplete voiding dysuria 3) Bowel symptoms: constipation diarrhea or alternating constipation/diarrhea 4) Dyspareunia or pain during intercourse 5) Pelvic pain or referred pain from trigger points in lower abdomen/lumbosacral region/buttocks; palpable taut bands in affected muscles; localized tenderness within taut bands; pressure on trigger points reproduces pain/referred pain 6) Elevated resting potential or prolonged recovery time on pelvic floor surface electromyography (sEMG) 7) Exclusion of other organic diseases causing chronic pelvic pain Diagnosis requires: 1 item from 1)-4) plus mandatory 5)+6)+7). TCM Syndrome Differentiation Criteria: Primary symptoms: Lower abdominal distension/pain/stabbing pain or lumbosacral pain Secondary symptoms: 1) Menstrual volume ?/? dark red menses ± clots 2) Dyspareunia aggravated abdominal pain pre-/post-menses 3) Depression/irritability hypochondriac/breast distension pain 4) Urinary hesitation dribbling 5) Loose stools dry stools or alternating stool consistency Tongue/pulse: Purple-dark tongue ± ecchymosis spots; wiry or wiry-choppy pulse Diagnosis requires: Primary symptoms + 2 items from 1)2)3) + 1 item from 4)5) + tongue/pulse signs. Inclusion Criteria: (1) Meet both Western and TCM diagnostic criteria for NPFD (2) Females aged 20-55 years with sexual activity history (3) Provide informed consent voluntarily and comply with scheduled follow-ups
Exclusion criteria
Exclusion criteria: (1) Patients with POP-Q stage II or higher pelvic organ prolapse; (2) Chronic pelvic pain from other causes: primary dysmenorrhea adenomyosis endometriosis pelvic inflammatory disease pelvic varices; history of pelvic radiotherapy; ultrasound-confirmed uterine/adnexal pathologies requiring surgery; concurrent vaginal bleeding or vaginitis; (3) Contraindications to low-frequency electrostimulation: epilepsy implanted cardiac pacemaker local sensory deficit acute hepatitis psychological aversion to electrostimulation; (4) Urological disorders: complicated urinary tract infections calculi; (5) Digestive disorders: irritable bowel syndrome refractory constipation; (6) Psychiatric disorders: depression schizophrenia; (7) Pelvic pain from neurological injuries: pudendal nerve injury cauda equina syndrome; (8) Women planning pregnancy currently pregnant or in puerperium (postpartum period).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pelvic surface electromyography test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression index;traditional chinese medicine tongue presentation;Female Sexual Function;insomnia severity index;Pelvic Pain Presentation;self-rating anxiety index;Pelvic Floor Impact index;traditional chinese medicine Syndrome Presentation;traditional chinese medicine Pulse Presentation; | — |
Countries
china
Contacts
Public Contactchenyisong
Obstetrics & Gynecology Hospital of Fudan University
Outcome results
None listed