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| Name | Class |
|---|---|
| Pavol Jozef Safarik University | OTHER |
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This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with Pudendal Neuralgia | Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist. |
| |
| Healthy women | Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor shear wave elastography | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores) | 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). |
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Inclusion Criteria (Pudendal Neuralgia Group)
Diagnosis of Pudendal Neuralgia based on the Nantes diagnostic criteria (Labat et al., 2008), specifically:
Inclusion Criteria (Healthy Controls)
Exclusion Criteria (Both Groups)
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Study Population This observational study enrolled adult women (≥18 years) categorized into two cohorts: a pudendal neuralgia (PN) group and a healthy control group.
Participants in the PN group were recruited from an outpatient clinic database. Inclusion required a diagnosis of pudendal neuralgia confirmed by a gynecologist according to the Nantes criteria (Labat et al., 2008), including a positive response to an anesthetic pudendal nerve block, and a symptom duration of ≥ 3 months.
The healthy control group consisted of volunteers recruited from university staff with no history of chronic pelvic pain or pelvic floor dysfunction.
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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 in Bratislava, Jessenius Faculty of Medicine , Martin, Slovakia | Martin | Slovakia | 040 22 | Slovakia |
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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.
. 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Women With Pudendal Neuralgia | Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist. |
| FG001 | Healthy Women | Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
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| ID | Title | Description |
|---|---|---|
| BG000 | Women With Pudendal Neuralgia | Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist. |
| BG001 | Healthy Women |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography | 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. | Posted | Median | Inter-Quartile Range | kilopascals | 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. |
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From the beginning of the imaging procedure until the end of the clinical assessment (approximately 1 hour per participant).
Adverse events were monitored by the investigator during and immediately after the ultrasound examination through clinical observation and participant self-reporting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Women With Pudendal Neuralgia | Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jan Svihra prof.MD. PhD. | Jessenius Faculty of Medicine Commenius University Bratislava Slovakia | +421905369155 | jan.svihra@uniba.sk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2023 | Mar 13, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060545 | Pudendal Neuralgia |
| ID | Term |
|---|---|
| D009408 | Nerve Compression Syndromes |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) | Diagnostic Test | 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. |
|
| Female Sexual Distress Scale-Revised (FSDS-R) | Diagnostic Test | 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. |
|
| 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. |
| Sexual Distress (FSDS-R Total Score) | Female Sexual Distress Scale-Revised (FSDS-R) total score (0-52). Higher scores indicate greater sexual distress. | 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. |
Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction.
| BG002 | Total | Total of all reporting groups |
The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls) |
| Count of Participants |
| Participants |
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| Sex/Gender, Customized | The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls) | Number | Participants |
|
| Race (NIH/OMB) | The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls) | The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls) | Count of Participants | Participants |
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| OG001 | Healthy Women | Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction. |
|
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| Secondary | Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores) | 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). | "Participants in the Healthy Women arm exhibited no pelvic floor dysfunction, urinary, colorectal-anal, or pelvic organ prolapse symptoms. Consequently, all participants in this control group scored 0 on the PFIQ-7 (including UIQ-7, CRAIQ-7, and POPIQ-7 subscales), resulting in a median score of 0.0 with zero variance (Inter-Quartile Range (IQR = 0.0)." | Posted | Median | Inter-Quartile Range | 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. |
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| Secondary | Sexual Distress (FSDS-R Total Score) | Female Sexual Distress Scale-Revised (FSDS-R) total score (0-52). Higher scores indicate greater sexual distress. | Participants in the Healthy Women arm reported a complete absence of sexual distress. As a result, every participant in this control group achieved the minimum possible score of 0 on the Female Sexual Distress Scale-Revised (FSDS-R), leading to a median score of 0.0 and a Inter-Quartile range (IQR)of 0.0 | Posted | Median | Inter-Quartile Range | 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. |
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| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Healthy Women | Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction. | 0 | 44 | 0 | 44 | 0 | 44 |
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| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Colorectal-Anal Impact Questionnaire, CRAIQ-7 |
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| Pelvic Organ Prolapse Impact Questionnaire, POPIQ-7 |
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