Clinical trial NCT03197337: Is Localized Provoked Vulvodynia Caused by Laxity of the Utero-Sacral Ligaments?
Official title: Is Localized Provoked Vulvodynia Caused by Laxity of the Utero-Sacral Ligaments?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvodynia
Referred Pain
Keywords: Vulvodynia
Localized Provoked Vulvodynia (LPV)
Referred pain
Utero-Sacral ligaments laxity
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2017-06-23
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: Patients with LPV who sign an informed consent form will first undergo the cotton-swab test during which they will rate the pain elicited on a scale of 1 to 10. This score will be used as the patient's baseline level of pain for data analysis later. Then, each patient will be randomized into one of two groups: One group which will first undergo the control manipulation and then the study manipulation, or the second group in which the study manipulation will precede the control manipulation. This is done to neutralize a possible effect of the order of the manipulations on the trial's results when the data will be analyzed.

The control manipulation: Inserting a speculum into the vagina without applying pressure.

The study manipulation: First inserting a speculum, then inserting through it a large-sized applicator reaching the posterior fornix, then retrieving the speculum while keeping the applicator in place, and then applying significant pressure to the posterior fornix.

During each of the manipulations, the cotton-swab test will be performed again, and each patient will be asked to rate the level of pain elicited by the test. All data will be recorded, and we will later analyze if there was a significant difference between the pain elicited by the cotton-swab test during the study manipulation compared with the control manipulation, or compared with the baseline test.

Eligibility criteria: Inclusion Criteria:

* Women who suffer from LPV that are otherwise healthy.
* Symptoms severity in each patient is either moderate (able to engage in sexual intercourse despite suffering immense pain) or severe (unable to engage in sexual intercourse due to unbearable pain).
* Patients who have signed an informed consent form.

Exclusion Criteria:

* Women who suffer from Generalized Vulvodynia.
* Women who previously received other treatments for LPV, including but not limited to surgery, neuropathic treatment and/or physiotherapy.
* Women with uterine prolapse.
* Women who present with genito-urinary infection/inflammation at the day of the trial, or have healed from such a condition less then 14 days prior to the day of the trial.
* Women who have previously participated in clinical trials under which they received treatment for Vulvodynia.
* Women with LPV whose symptoms severity is defined as light (able to engage in sexual intercourse while suffering light pain / discomfort).
* Women who are pregnant at the day of the trial.

Primary outcomes:
measure: Level of pain
timeFrame: Immediate result
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Department of Obstetrics and Gynecology
Study officials:
affiliation: Chair, Obstetrics and Gynecology department
name: Jacob Bornstein, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petros P, Bornstein J. Re: vulvar vestibulitis may be a referred pain arising from laxity in the uterosacral ligaments: a hypothesis based on three prospective case reports. Aust N Z J Obstet Gynaecol. 2004 Oct;44(5):484-5. doi: 10.1111/j.1479-828X.2004.00297.x. No abstract available.
citation: Bornstein J, Zarfati D, Petros P. Re: Causation of vulvar vestibulitis. Aust N Z J Obstet Gynaecol. 2005 Dec;45(6):538-9. doi: 10.1111/j.1479-828X.2005.00499.x. No abstract available.
citation: Friedrich EG Jr. Vulvar vestibulitis syndrome. J Reprod Med. 1987 Feb;32(2):110-4.
citation: Bornstein J, Goldstein AT, Stockdale CK, Bergeron S, Pukall C, Zolnoun D, Coady D; consensus vulvar pain terminology committee of the International Society for the Study of Vulvovaginal Disease (ISSVD); International Society for the Study of Women's Sexual Health (ISSWSH); International Pelvic Pain Society (IPPS). 2015 ISSVD, ISSWSH, and IPPS Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia. J Sex Med. 2016 Apr;13(4):607-12. doi: 10.1016/j.jsxm.2016.02.167. Epub 2016 Mar 25.