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

NCT03197337 | Completed

• 1 other identifier: 004317NHR
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvodynia; Referred Pain

Keywords

Vulvodynia; Localized Provoked Vulvodynia (LPV); Referred pain; Utero-Sacral ligaments laxity

Outcome Measures

Primary Outcomes (1)

• Level of pain

  Patients will rate the level of pain elicited each time the cotton-swab test will be performed, using a 1-10 scale (1 - not painful, 10 - worst pain imaginable).

  Immediate result

Study Arms (2)

Control manipulation first

EXPERIMENTAL

Patients in this group will first undergo the control manipulation while the study manipulation will follow.

Procedure: Pressure-test

Study manipulation First

EXPERIMENTAL

Patients in this group will first undergo the study manipulation while the control manipulation will follow.

Procedure: Pressure-test

Interventions

Pressure-test PROCEDURE

Pressure will be applied to the posterior fornix using a speculum.

Control manipulation first; Study manipulation First

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Department of Obstetrics and Gynecology

Nahariya, Israel

Location

Related Publications (4)

• 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.

  PMID: 15387884 BACKGROUND

• 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.

  PMID: 16401228 BACKGROUND

• Friedrich EG Jr. Vulvar vestibulitis syndrome. J Reprod Med. 1987 Feb;32(2):110-4.

  PMID: 3560069 BACKGROUND

• 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.

  PMID: 27045260 BACKGROUND

MeSH Terms

Conditions

Vulvodynia; Pain, Referred

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacob Bornstein, Prof

  Chair, Obstetrics and Gynecology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not be informed prior to the experiment if they will first undergo the control manipulation or the study manipulation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 23, 2017
• Study Start: July 23, 2017
• Primary Completion: March 2, 2018
• Study Completion: March 2, 2018
• Last Updated: October 15, 2019

Record last verified: 2019-10

Locations

IL (1)