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

Not Applicable

Completed

• Conditions: Referred Pain; Vulvodynia
• Interventions: Procedure: Pressure-test

• Registration Number: NCT03197337
• Lead Sponsor: Western Galilee Hospital-Nahariya

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.

Study Timeline

• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-23
• Study Start: 2017-07-23
• Primary Completion: 2018-03-02
• Study Completion: 2018-03-02
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-13
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study manipulation First	Pressure-test	Patients in this group will first undergo the study manipulation while the control manipulation will follow.
Control manipulation first	Pressure-test	Patients in this group will first undergo the control manipulation while the study manipulation will follow.

Primary Outcome Measures

Name	Time	Method
Level of pain	Immediate result	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).

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology; 🇮🇱 Nahariya, Israel