Is Localized Provoked Vulvodynia Caused by Laxity of the Utero-Sacral Ligaments?
Primary Purpose
Vulvodynia, Referred Pain
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Pressure-test
Sponsored by
About this trial
This is an interventional diagnostic trial for Vulvodynia focused on measuring Vulvodynia, Localized Provoked Vulvodynia (LPV), Referred pain, Utero-Sacral ligaments laxity
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.
Sites / Locations
- Department of Obstetrics and Gynecology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control manipulation first
Study manipulation First
Arm Description
Patients in this group will first undergo the control manipulation while the study manipulation will follow.
Patients in this group will first undergo the study manipulation while the control manipulation will follow.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03197337
First Posted
June 22, 2017
Last Updated
October 13, 2019
Sponsor
Western Galilee Hospital-Nahariya
1. Study Identification
Unique Protocol Identification Number
NCT03197337
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 23, 2017 (Actual)
Primary Completion Date
March 2, 2018 (Actual)
Study Completion Date
March 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Galilee Hospital-Nahariya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia, Referred Pain
Keywords
Vulvodynia, Localized Provoked Vulvodynia (LPV), Referred pain, Utero-Sacral ligaments laxity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The participants will not be informed prior to the experiment if they will first undergo the control manipulation or the study manipulation.
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control manipulation first
Arm Type
Experimental
Arm Description
Patients in this group will first undergo the control manipulation while the study manipulation will follow.
Arm Title
Study manipulation First
Arm Type
Experimental
Arm Description
Patients in this group will first undergo the study manipulation while the control manipulation will follow.
Intervention Type
Procedure
Intervention Name(s)
Pressure-test
Intervention Description
Pressure will be applied to the posterior fornix using a speculum.
Primary Outcome Measure Information:
Title
Level of pain
Description
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).
Time Frame
Immediate result
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Bornstein, Prof
Organizational Affiliation
Chair, Obstetrics and Gynecology department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology
City
Nahariya
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
15387884
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.
Results Reference
background
PubMed Identifier
16401228
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.
Results Reference
background
PubMed Identifier
3560069
Citation
Friedrich EG Jr. Vulvar vestibulitis syndrome. J Reprod Med. 1987 Feb;32(2):110-4.
Results Reference
background
PubMed Identifier
27045260
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.
Results Reference
background
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Is Localized Provoked Vulvodynia Caused by Laxity of the Utero-Sacral Ligaments?
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