Pudendal Neuralgia- Physiotherapy
Conditions
Keywords
Pudendal neuralgia Chronic pelvic pain Pelvic floor physiotherapy Shear-wave elastography Pelvic floor muscle stiffness
Brief summary
This randomized controlled trial compares a 6-month physiotherapy exercise program versus no structured exercise intervention in women with pudendal neuralgia. Outcomes include pelvic floor muscle stiffness measured by shear-wave elastography (SWE), pelvic floor symptom burden (PFIQ-7), sexual distress (FSDS-R), and pain/discomfort scores (VAS).
Interventions
BEHAVIORALPelvic Floor Relaxation Protocol
A structured 6-month physiotherapy program was implemented, focusing on pelvic floor muscle relaxation, postural correction, and functional movement patterns.The program included 6 individual sessions with a physiotherapist and mandatory daily home exercise (30 minutes/day). Adherence was recorded in participant diaries.
Sponsors
Comenius University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female participants aged 18 years or older * Confirmed diagnosis of pudendal neuralgia based on all five Nantes diagnostic criteria * Duration of symptoms at least 3 months * Written informed consent provided
Exclusion criteria
* History of psychiatric, neurological (except pudendal neuralgia), severe internal medical, orthopedic, or oncological disease * Botulinum toxin therapy within the previous 12 months * Pelvic surgery within the previous 12 months * Incomplete or incorrectly completed questionnaires * Refusal to participate or withdrawal of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic floor muscle stiffness by shear-wave elastography (SWE) | Baseline and 6 months (post-intervention) | Pelvic floor muscle stiffness (kPa) measured by shear-wave elastography in superficial pelvic floor muscles (bulbospongiosus, ischiocavernosus, and superficial transverse perineal muscles). Measurements were obtained using a 2 mm circular ROI with real-time quality control (RLB \> 90%, M-STB 4-5 stars). Shell analysis was used to identify sites of minimum and maximum stiffness within each muscle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) | Baseline and 6 months (post-intervention) | PFIQ-7 is a 21-item questionnaire assessing the impact of pelvic floor disorders across urinary, colorectal-anal, and prolapse/vaginal symptom domains. Total score ranges from 0 to 300; higher scores indicate greater negative impact on quality of life. |
| Female Sexual Distress Scale-Revised (FSDS-R) | Baseline and 6 months (post-intervention) | FSDS-R is a 13-item questionnaire measuring sexually related personal distress. Each item is scored on a 5-point Likert scale (0-4). Total score ranges from 0 to 52; higher scores indicate greater sexual distress. |
| Pain/discomfort intensity by visual analog scale (VAS) | Baseline and 6 months (post-intervention) | Pain and discomfort were assessed using VAS in five domains: bladder, vagina, perineum, rectum, and dyspareunia (pain during sexual intercourse). |
Countries
Slovakia
Contacts
PRINCIPAL_INVESTIGATORMagdalena Hagovska, prof.PhDr.PhD.
Pavol Jozef Safarik University, Medical Faculty, Kosice Slovakia
STUDY_DIRECTORJan Svihra, prof.MUDr.PhD.
Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia
Outcome results
None listed