Healthy Women, Pudendal Nerve
Conditions
Keywords
Pudendal neuralgia, Shear-wave elastography, Healthy women
Brief summary
This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia.
Detailed description
Using shear-wave elastography, this study will compare the superficial pelvic floor muscles (bulbospongiosus, ischiocavernosus, and superficial transverse perineal muscles) between healthy women and women with pudendal neuralgia.
Interventions
DIAGNOSTIC_TESTPelvic floor shear wave elastography
Imaging was performed using a Consona N8 ultrasound system (Shenzhen Mindray Bio-Medical Electronics Co., Ltd.) equipped with shear-wave elastography (SWE) software. A linear-array transducer (L13-3N; frequency range 3.0-13.0 MHz; field of view \~3.8-4.0 cm) was used to obtain pelvic floor muscle (PFM) images. Measurements were performed using shell analysis by comparing two locations within the same pelvic floor muscle: the sites with the highest and lowest stiffness (kPa).
DIAGNOSTIC_TESTPelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7)
The PFIQ-7 is a 21-item questionnaire (three scales with seven items each) assessing the impact of pelvic floor disorders on daily life. Items are scored from 0 to 3, and the total score ranges from 0 to 300. Higher scores indicate greater impact/distress.
DIAGNOSTIC_TESTFemale Sexual Distress Scale-Revised (FSDS-R)
The FSDS-R is a 13-item questionnaire assessing sexually related personal distress in women, with a total score range of 0-52. Items are rated on a 5-point Likert scale (0 = never to 4 = always). Higher scores indicate greater sexual distress.
Sponsors
Comenius University
Pavol Jozef Safarik University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(Pudendal Neuralgia Group) Diagnosis of Pudendal Neuralgia based on the Nantes diagnostic criteria (Labat et al., 2008), specifically: * Pain located in the anatomical territory of the pudendal nerve. * Pain worsened by sitting. * Pain that does not wake the patient at night. * No objective sensory loss on clinical examination. * Positive response to an anesthetic pudendal nerve block. * Duration of symptoms: Chronic pelvic pain persisting for more than 3 months. * Demographics: Women aged (≥18 years). * Voluntary participation: Ability to understand and sign informed consent. Inclusion Criteria (Healthy Controls) * Demographics: Women aged (≥18 years). * Asymptomatic status: No history or current symptoms of chronic pelvic pain or pelvic floor dysfunction (confirmed by clinical interview/screening). * Voluntary participation: Signed informed consent.
Exclusion criteria
(Both Groups) * Medical Comorbidities: Diagnosed psychiatric, neurological (other than PN), severe internal, orthopedic, or oncological diseases that could interfere with the study outcomes. * Recent Interventions: History of botulinum toxin therapy to the pelvic floor within the last 12 months. * Pelvic surgery within the last 12 months. * Data Integrity: Incomplete or incorrectly filled questionnaires. * General: Unwillingness to participate or inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography | Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously. | Stiffness of superficial pelvic floor muscles (bulbospongiosus, ischiocavernosus, superficial transverse perineal muscles) assessed with SWE; comparison between healthy women and women with pudendal neuralgia. Shell analysis was used to identify and compare two specific locations within each muscle: the site of maximum stiffness (b-site) and the site of minimum stiffness (a-site). The data represent the maximum stiffness measured at the most affected sites in KPa. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores) | Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously. | The Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) is a 21-item instrument that assesses the impact of pelvic floor disorders across three domains: bladder (Urinary Impact Questionnaire, UIQ-7), bowel (Colorectal-Anal Impact Questionnaire, CRAIQ-7), and vaginal symptoms (Pelvic Organ Prolapse Impact Questionnaire, POPIQ-7). Scale Ranges: Each of the three subscales (UIQ-7, CRAIQ-7, and POPIQ-7) is scored from 0 to 100. The PFIQ-7 Total Score is calculated as the sum of these three subscales, ranging from a minimum of 0 to a maximum of 300. Interpretation: For all subscales and the total score, higher values represent a worse outcome (greater negative impact on quality of life). |
| Sexual Distress (FSDS-R Total Score) | Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously. | Female Sexual Distress Scale-Revised (FSDS-R) total score (0-52). Higher scores indicate greater sexual distress. |
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
Participant flow
Recruitment details
. A total of 94 potential participants were assessed for eligibility, including 49 women with PN (potential cases) and 45 healthy volunteers (potential controls). Based on the inclusion and exclusion criteria, 5 cases were excluded (3 because of refusal and 2 because of botulinum toxin therapy) and 1 control was excluded because of refusal. The final sample included in the analysis consisted of 88 participants: 44 cases with PN and 44 healthy controls.
Pre-assignment details
A total of 94 potential participants were assessed for eligibility, including 49 women with PN (potential cases) and 45 healthy volunteers (potential controls). Based on the inclusion and exclusion criteria, 5 cases were excluded (3 because of refusal and 2 because of botulinum toxin therapy) and 1 control was excluded because of refusal. The final sample included in the analysis consisted of 88 participants: 44 cases with PN and 44 healthy controls.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 88 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 88 Participants |
| Sex/Gender, Customized White | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 44 |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
None listed