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Subtypes of Provoked Vestibulodynia

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ClinicalTrials.gov Identifier: NCT02712814
Recruitment Status : Recruiting
First Posted : March 18, 2016
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ahinoam Lev-Sagie, Meir Medical Center

Brief Summary:
The proposed study will evaluate a clinical algorithm for the diagnosis and treatment of provoked vestibulodynia (PVD). The algorithm, distinguishes between four subtypes of PVD: hormonally mediated PVD, hypertonic pelvic floor dysfunction, congenital neuroproliferative PVD and acquired neuroproliferative PVD, based on a patient's history and physical exam. The study will follow patients diagnosed with PVD, for one year, and evaluate the treatment outcome in the different subgroups. Investigators hope that conducting a prospective study, showing clinical benefit and improved outcome for patients classified according to this method may change the common practice of "trial and error" based treatment, and will improve clinical results.

Condition or disease Intervention/treatment
Provoked Localized Vulvodynia Drug: Topical hormonal cream (estrogen) Procedure: Pelvic floor physical therapy Procedure: Low Level Laser therapy

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Subtypes of Provoked Vestibulodynia: A Prospective Study to Evaluate a Diagnostic Algorithm in Regard to Different Treatment Modalities
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hormonally mediated PVD
  • The entire vestibule is tender
  • The pain began while taking hormonal contraceptive
  • Secondary PVD
  • On exam, atrophic vestibular tissue (dry and thin)
Drug: Topical hormonal cream (estrogen)
Patients will be instructed to stop hormonal contraception and to apply 0.1 ml topical cream containing 0.1% of estriol to the vestibule, once daily for 3 months

Congenital Neuroproliferative PVD
  • The entire vestibule is tender
  • Primary PVD
  • There may be sensitivity to palpation of the umbilicus
  • Normal appearing vestibule
Procedure: Low Level Laser therapy
non-thermal laser irradiation (low levels of red and near infrared light) is applied directly to the vestibule

Acquired neuroproliferative PVD
  • The entire vestibule is tender
  • Secondary PVD, The pain had begun after a severe allergic reaction or vaginitis.
  • Normal appearing vestibule
Procedure: Low Level Laser therapy
non-thermal laser irradiation (low levels of red and near infrared light) is applied directly to the vestibule

Hypertonic pelvic muscle dysfunction
  • The pain is at 4-8 o'clock position of the vestibule with minimal or no pain in the upper vestibule
  • Pelvic floor muscles are tight and tender
  • Primary or Secondary PVD
Procedure: Pelvic floor physical therapy
PF physical therapy once weekly for 3 months

Neuroproliferative +Hypertonic

The entire vestibule is tender, but worse at 4-8 o'clock position of the vestibule

  • Primary PVD
  • There may be sensitivity to palpation of the umbilicus
  • Normal appearing vestibule
  • Pelvic floor muscles are tight and tender
Procedure: Pelvic floor physical therapy
PF physical therapy once weekly for 3 months

Procedure: Low Level Laser therapy
non-thermal laser irradiation (low levels of red and near infrared light) is applied directly to the vestibule

Hormonally +Hypertonic

The entire vestibule is tender, but worse at 4-8 o'clock position of the vestibule

  • The pain began while taking hormonal contraceptive
  • Secondary PVD
  • On exam, atrophic vestibular tissue (dry and thin)
  • Pelvic floor muscles are tight and tender
Drug: Topical hormonal cream (estrogen)
Patients will be instructed to stop hormonal contraception and to apply 0.1 ml topical cream containing 0.1% of estriol to the vestibule, once daily for 3 months

Procedure: Pelvic floor physical therapy
PF physical therapy once weekly for 3 months




Primary Outcome Measures :
  1. Change of measure of Q tip test assesing pain intensity [ Time Frame: Change in measure between recruitment to 3 months, 6 months 6 months, 9 months and 12 months ]
    The exam is performed by touching the vestibule with a cotton-tip applicator in 6 defined points (2,5,6,7, 10 and 12),while the patient is being asked to rate the intensity of pain verbally from 0 to 10 at each point.


Secondary Outcome Measures :
  1. Visual analog scale (VAS) [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months ]
  2. Measurement of vestibular tenderness using a vulvar algesiometer [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months ]
  3. QOL parameters (questionnaire) [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months ]
  4. Improvement in condition using a verbal report [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months ]
    in the follow-up appointments, patients will be asked to estimate the change in their condition, using percentage scaling: no or little improvement (<30%), moderate improvement (30-80%), much improvement (>80%) and total improvement (100%).

  5. Tampon test [ Time Frame: Every month for one year ]
    Patients will be provided with original Regular Tampax Tampons and will be instructed to deposit the tampon fully into the vagina above the level of the hymeneal ring with the applicator, remove the applicator from the vagina, and finally remove the tampon from the vagina by traction on the tampon string, immediately after vaginal insertion, without any lubrication. Patients will record the degree of pain during the entire insertion- removal experience, on a 0-10 pain numeric scale, with 0 meaning no pain, and 10 meaning the worst possible pain.

  6. Female sexual function index [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients will be recruited from the clinic for vulvovaginal disorders in Clalit Healthcare services in Jerusalem.
Criteria

Inclusion Criteria:

  1. A history of 3 months or more of vulvar pain suggestive of PVD, i.e. symptoms of pain on vaginal penetration (insertional dyspareunia and/or pain with tampon insertion).
  2. On exam, tenderness localized within the vestibule when being touched with a cotton-tip applicator.
  3. No identifiable cause for the pain, such as vulvovaginal candidiasis, vaginal atrophy, desquamative inflammatory vaginitis (DIV), herpes, dermatitis or vulvar dystrophy.

Exclusion criteria:

  1. other causes for vulvar pain
  2. pregnancy or a planned pregnancy in the upcoming year
  3. unprovoked or mixed vulvodynia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712814


Contacts
Contact: Ahinoam Lev-Sagie, MD +972-8-9762666 levsagie@netvision.net.il

Locations
Israel
Ramat Eshkol Women health center, Clalit health Services Recruiting
Jerusalem, Israel
Contact: Ahinoam Lev-Sagie, MD    972-2-5889500 ext 3    Levsagie@netvision.net.il   
Sponsors and Collaborators
Meir Medical Center

Responsible Party: Ahinoam Lev-Sagie, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02712814     History of Changes
Other Study ID Numbers: 0152-15-COM1
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs