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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic Floor Relaxation Protocol | Experimental | Participants received a 6-month physiotherapy intervention consisting of 6 individual sessions with a physiotherapist and daily home exercise (30 minutes/day). |
|
| Control | No Intervention | Participants did not receive the structured physiotherapy exercise program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic Floor Relaxation Protocol | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic floor muscle stiffness by shear-wave elastography (SWE) | 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. | Baseline and 6 months (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) | 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. | Baseline and 6 months (post-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
History of psychiatric, neurological (except pudendal neuralgia), severe internal medical, orthopedic, or oncological disease
Yes (if PRS asks whether eligibility is based on sex/gender)
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| Name | Affiliation | Role |
|---|---|---|
| Magdalena Hagovska, prof.PhDr.PhD. | Pavol Jozef Safarik University, Medical Faculty, Kosice Slovakia | Principal Investigator |
| Jan Svihra, prof.MUDr.PhD. | Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia | Martin | Slovakia | Slovakia |
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| Female Sexual Distress Scale-Revised (FSDS-R) | 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. | Baseline and 6 months (post-intervention) |
| Pain/discomfort intensity by visual analog scale (VAS) | Pain and discomfort were assessed using VAS in five domains: bladder, vagina, perineum, rectum, and dyspareunia (pain during sexual intercourse). | Baseline and 6 months (post-intervention) |