VulvodyniaNCT03197337
Is Localized Provoked Vulvodynia Caused by Laxity of the Utero-Sacral Ligaments?
A study testing Pressure-test in people with Vulvodynia and Referred Pain, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Vulvodynia, Referred Pain
- What is being tested?
- Pressure-test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Jul 2017to 2 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Vulvodynia, Referred Pain
- Being tested
- Pressure-test
- Keywords
- Vulvodynia, Localized Provoked Vulvodynia (LPV), Referred pain, Utero-Sacral ligaments laxity
- Medical subject headings
- Vulvodynia, Pain, Referred
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure-testProcedure or surgery
Pressure will be applied to the posterior fornix using a speculum.
| Study group | Role | What they receive |
|---|---|---|
| Control manipulation first | Experimental | Patients in this group will first undergo the control manipulation while the study manipulation will follow. Receives: Procedure: Pressure-test |
| Study manipulation First | Experimental | Patients in this group will first undergo the study manipulation while the control manipulation will follow. Receives: Procedure: Pressure-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediate result
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start23 Jul 2017
- Primary completion2 Mar 2018
- Study completion2 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
- Investigators
- Jacob Bornstein, Prof, Principal investigator, Chair, Obstetrics and Gynecology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197337
- Sponsor's protocol ID
- 004317NHR
- Status last verified
- Oct 2019
- First submitted
- 22 Jun 2017
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15387884Bornstein 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.
PubMed 16401228Friedrich EG Jr. Vulvar vestibulitis syndrome. J Reprod Med. 1987 Feb;32(2):110-4.
PubMed 3560069Bornstein 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.
PubMed 27045260
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Localized Provoked Vulvodynia Caused by Laxity of the Utero-Sacral Ligaments?
- ClinicalTrials.gov ID
- NCT03197337
- Acronym / sponsor ID
- 004317NHR
- Conditions
- Vulvodynia, Referred Pain
- Keywords
- Vulvodynia, Localized Provoked Vulvodynia (LPV), Referred pain, Utero-Sacral ligaments laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 23 Jul 2017 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control manipulation first | Experimental | Procedure: Pressure-testPatients in this group will first undergo the control manipulation while the study manipulation will follow. |
| Study manipulation First | Experimental | Procedure: Pressure-testPatients in this group will first undergo the study manipulation while the control manipulation will follow. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure-testPressure will be applied to the posterior fornix using a speculum. | Procedure or surgery | Control manipulation first, Study manipulation First |
Primary outcome
Level of pain
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Background: PubMed 15387884Petros 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.
- Background: PubMed 16401228Bornstein 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.
- Background: PubMed 3560069Friedrich EG Jr. Vulvar vestibulitis syndrome. J Reprod Med. 1987 Feb;32(2):110-4.
- Background: PubMed 27045260Bornstein 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.
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Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Bornstein, Prof principal investigator
Chair, Obstetrics and Gynecology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure-test in people with Vulvodynia and Referred Pain, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of pain (time frame: Immediate result). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03197337, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.