Trial Outcomes & Findings for Pelvic Floor Shear-Wave Elastography in Healthy and Pudendal Neuralgia Women (NCT NCT07458737)
NCT ID: NCT07458737
Last Updated: 2026-07-06
Results Overview
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.
COMPLETED
94 participants
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.
2026-07-06
Participant Flow
. 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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
|
Overall Study
COMPLETED
|
44
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
Baseline characteristics by cohort
| Measure |
Women With Pudendal Neuralgia
n=44 Participants
Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist.
|
Healthy Women
n=44 Participants
Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=27 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=267 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=9 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
44 Participants
n=27 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
88 Participants
n=267 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=27 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=267 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
|
Sex/Gender, Customized
White
|
44 Participants
n=9 Participants
|
44 Participants
n=27 Participants
|
88 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=27 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=267 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=27 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=267 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=27 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=267 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=27 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=267 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
|
Race (NIH/OMB)
White
|
44 Participants
n=9 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
44 Participants
n=27 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
88 Participants
n=267 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=27 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=267 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=27 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
0 Participants
n=267 Participants • The analysis includes only participants who met all inclusion criteria and completed the measurements (44 cases with PN and 44 healthy controls)
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Healthy Women
n=44 Participants
Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction.
|
Women With Pudendal Neuralgia
n=44 Participants
Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist.
|
|---|---|---|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.transverse perineal- left side, a-places with the lowest stiffness
|
15.0 kilopascals
Interval 11.0 to 37.8
|
22.5 kilopascals
Interval 18.2 to 27.0
|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.bulbospongiosus- right side, b-places with the highest stiffness
|
26.5 kilopascals
Interval 23.0 to 167.2
|
612.0 kilopascals
Interval 423.0 to 695.5
|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.bulbospongiosus- right side, a-places with the lowest stiffness
|
21.0 kilopascals
Interval 15.5 to 24.0
|
33.0 kilopascals
Interval 27.2 to 39.0
|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.bulbospongiosus- left side, b-places with the highest stiffness
|
149.0 kilopascals
Interval 39.5 to 330.0
|
572.0 kilopascals
Interval 408.5 to 665.5
|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.bulbospongiosus- left side, a-places with the lowest stiffness
|
23.9 kilopascals
Interval 14.6 to 26.0
|
25.0 kilopascals
Interval 17.2 to 37.5
|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.ischiocavernosus- right side, b-places with the highest stiffness
|
120.0 kilopascals
Interval 51.6 to 158.8
|
324.5 kilopascals
Interval 223.5 to 487.0
|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.ischiocavernosus- right side, a-places with the lowest stiffness
|
15.0 kilopascals
Interval 9.0 to 29.0
|
25.5 kilopascals
Interval 15.8 to 41.5
|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.ischiocavernosus- left side, b-places with the highest stiffness
|
150.0 kilopascals
Interval 72.0 to 168.9
|
305.0 kilopascals
Interval 195.5 to 440.0
|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.ischiocavernosus- left side, a-places with the lowest stiffness
|
21.0 kilopascals
Interval 10.2 to 28.8
|
23.0 kilopascals
Interval 17.0 to 32.8
|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.transverse perineal- right side, b-places with the highest stiffness
|
29.0 kilopascals
Interval 21.2 to 90.0
|
451.5 kilopascals
Interval 249.8 to 572.8
|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.transverse perineal- right side, a-places with the lowest stiffness
|
15.4 kilopascals
Interval 11.5 to 23.0
|
29.0 kilopascals
Interval 18.0 to 34.8
|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.transverse perineal- left side, b-places with the highest stiffness
|
18.0 kilopascals
Interval 9.5 to 205.3
|
299.5 kilopascals
Interval 190.2 to 426.2
|
SECONDARY outcome
Timeframe: 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.Population: "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)."
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).
Outcome measures
| Measure |
Healthy Women
n=44 Participants
Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction.
|
Women With Pudendal Neuralgia
n=44 Participants
Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist.
|
|---|---|---|
|
Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores)
Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7)- total score
|
0.0 score
Interval 0.0 to 0.0
|
200.0 score
Interval 133.3 to 300.0
|
|
Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores)
Urinary Impact Questionnaire, UIQ-7
|
0.0 score
Interval 0.0 to 0.0
|
100.0 score
Interval 10.7 to 100.0
|
|
Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores)
Colorectal-Anal Impact Questionnaire, CRAIQ-7
|
0.0 score
Interval 0.0 to 0.0
|
66.7 score
Interval 0.0 to 100.0
|
|
Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores)
Pelvic Organ Prolapse Impact Questionnaire, POPIQ-7
|
0.0 score
Interval 0.0 to 0.0
|
100.0 score
Interval 69.0 to 100.0
|
SECONDARY outcome
Timeframe: 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.Population: 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
Female Sexual Distress Scale-Revised (FSDS-R) total score (0-52). Higher scores indicate greater sexual distress.
Outcome measures
| Measure |
Healthy Women
n=44 Participants
Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction.
|
Women With Pudendal Neuralgia
n=44 Participants
Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist.
|
|---|---|---|
|
Sexual Distress (FSDS-R Total Score)
|
0 score
Interval 0.0 to 0.0
|
52 score
Interval 29.2 to 52.0
|
Adverse Events
Women With Pudendal Neuralgia
Healthy Women
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jan Svihra prof.MD. PhD.
Jessenius Faculty of Medicine Commenius University Bratislava Slovakia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place