NCT03197337

Is Localized Provoked Vulvodynia Caused by Laxity of the Utero-Sacral Ligaments?

Completed NA Last updated 15 October 2019

What this trial tests

NA trial testing Pressure-test in Vulvodynia in 17 participants. Completed in 2 March 2018.

Timeline

23 July 2017

Primary endpoint
2 March 2018

2 March 2018

Quick facts

Lead sponsor	Western Galilee Hospital-Nahariya
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	17
Start date	23 July 2017
Primary completion	2 March 2018
Estimated completion	2 March 2018
Sites	1 location across Israel

Drugs / interventions tested

• Pressure-test

Conditions studied

• Vulvodynia — all drugs for Vulvodynia →
• Referred Pain — all drugs for Referred Pain →

Sponsor

Western Galilee Hospital-Nahariya

Who can join

Adults 18 to 30, female only, with Vulvodynia or Referred Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Small-scale experiments conducted by our group have led to the hypothesis that Localized Provoked Vulvodynia (LPV) may be due to laxity of the Utero-Sacral ligaments (USL). According to this hypothesis, the pain experienced by women with LPV is due to the USL's inability to provide appropriate support for the pudendal nerve.

In order to test this hypothesis we will conduct a single-blind randomized control trial in which patients with LPV will undergo a pressure-test - pressure will be temporarily applied to the posterior fornix using a large-sized applicator, thus strengthening the USL and adding support to the pudendal nerve. While the pressure is being applied, the cotton-swab test will be performed (palpating vulvar and vestibular sites using a cotton-swab), and each patient will rate the elicited pain on a scale of 1 to 10 (1 - not painful, 10 - worst pain imaginable).

The results for each patient will be compared to their baseline level of pain (which will be recorded in the beginning of the experiment) and to the level of pain they report while inserting a speculum but not applying any pressure.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mechanically Supporting Uterosacral Ligaments for the Relief of Provoked Vulvodynia: A Randomized Pilot Trial.
   Schonfeld M, Petros P, Bornstein J. · · 2021 · cited 3× · PMID 34040432 · DOI 10.2147/jpr.s296613