Trial Outcomes & Findings for Pelvic Floor Shear-Wave Elastography in Healthy and Pudendal Neuralgia Women (NCT NCT07458737)
NCT ID: NCT07458737
Last Updated: 2026-04-02
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. Detailed results for all measured anatomical locations and planes are provided in the full study manuscript.
COMPLETED
94 participants
Baseline (Day 1 after enrollment; single assessment)
2026-04-02
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=5 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=5 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=10 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=5 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=5 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=10 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=5 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=5 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=10 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=5 Participants
|
44 Participants
n=5 Participants
|
88 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 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=5 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=10 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=5 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=5 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=10 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=5 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=5 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=10 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=5 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=5 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=10 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=5 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=5 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=10 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=5 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=5 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=10 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=5 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=5 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=10 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)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. Detailed results for all measured anatomical locations and planes are provided in the full study manuscript.
Outcome measures
| 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.
|
|---|---|---|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.bulbospongiosus
|
612 kilopascals
Interval 423.0 to 695.5
|
26.5 kilopascals
Interval 23.0 to 167.2
|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
m.ischiocavernosus
|
324.5 kilopascals
Interval 223.5 to 487.0
|
120 kilopascals
Interval 51.6 to 158.8
|
|
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
superficial transverse perineal muscles
|
451.5 kilopascals
Interval 249.8 to 572.8
|
29.0 kilopascals
Interval 21.2 to 90.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1 after enrollment; single assessment)Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) This 21-item instrument 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. Items are scored from 0 to 3, with total scores ranging from 0 to 300; higher scores indicate a greater negative impact on quality of life .
Outcome measures
| 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.
|
|---|---|---|
|
Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores)
|
200 score
Interval 133.3 to 300.0
|
0 score
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1 after enrollment; single assessment)Female Sexual Distress Scale-Revised (FSDS-R) total score (0-52). Higher scores indicate greater sexual distress.
Outcome measures
| 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.
|
|---|---|---|
|
Sexual Distress (FSDS-R Total Score)
|
52 score
Interval 29.2 to 52.0
|
0 score
Interval 0.0 to 0.0
|
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