Clinical trial · Observational
Learning Curve for the Visualization of Sacral Plexus on TVS
Evaluation of the Learning Curve for the Visualization of Sacral Nerve Roots and Sacral Plexus on Gynecological Transvaginal Ultrasound - PlexUS Study
NCT06041347CI-TRIAL-00069696PlexUSunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this prospective study was to evaluate the learning curve of TVUS (transvaginal ultrasound) for the visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound. The investigators aim to evaluate to evaluate the number needed to gain competence or to review the level of competence.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometriosis | — | UNRESOLVED | — |
| Nerve Sheath Tumor | Nerve Sheath Neoplasm | ALIAS | 0.90 |
| Radiculopathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transvaginal ultrasound | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The number of scans to gain competency for the visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound
- timeFrame
- 12 months
- description
- The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate.
Secondary outcomes (3)
- measure
- inter and intraobserver variability
- timeFrame
- 12 months
- description
- The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pelvic pain scheduled for TVS Exclusion Criteria: * 18 years * Women who have never been sexually active * (suspected) Pelvic malignancy for example gynecological, intestinal or urological malignancy * Premenarche * Pregnancy * Patients refusal to participate to the study
References
Publications (2)
- RESULTSzabo G, Madar I, Hudelist G, Aranyi Z, Turtoczki K, Rigo J Jr, Acs N, Liptak L, Fancsovits V, Bokor A. Visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound: feasibility study. Ultrasound Obstet Gynecol. 2023 Aug;62(2):290-299. doi: 10.1002/uog.26204. PMID 36938682
- RESULTFischerova D, Santos G, Wong L, Yulzari V, Bennett RJ, Dundr P, Burgetova A, Barsa P, Szabo G, Sousa N, Scovazzi U, Cibula D. Imaging in gynecological disease (26): clinical and ultrasound characteristics of benign retroperitoneal pelvic peripheral-nerve-sheath tumors. Ultrasound Obstet Gynecol. 2023 Nov;62(5):727-738. doi: 10.1002/uog.26223. PMID 37058402