The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia
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|ClinicalTrials.gov Identifier: NCT02892214|
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment|
|Localized Provoked Vulvodynia||Procedure: Pelvic floor physical therapy Drug: estriol cream (ovestin) Procedure: Low-level-laser therapy|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||120 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia, and the Mental Health of the Patient|
|Actual Study Start Date :||November 30, 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Hypertonic pelvic muscle dysfunction
In this subgroup, pelvic floor (PF) muscles become tight and tender. Typically, the pain is much worse at 4-8 o'clock position of the vestibule with minimal or no pain in the upper vestibule.
Procedure: Pelvic floor physical therapy
Hormonally mediated PVD
The pain began while taking hormonal contraceptive or other medications that affect hormones, after removal of ovaries, breastfeeding or menopause. The entire vestibule is tender and vestibular mucosa is often dry and thin.
Drug: estriol cream (ovestin)
In this condition, we speculate that women have an increased number of nociceptors in the vestibular mucosa. Pain is primary and there is tenderness of the entire vestibule.
Procedure: Low-level-laser therapy
- Change of measure of Q tip test assessing pain intensity [ Time Frame: Change in measure between recruitment to 3 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.
- 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. ]
- Change of pain using Visual analog scale [ Time Frame: Change in VAS between recruitment to 3 months, 6 months , 9 months and 12 months ]
- Adherence to therapy [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months. ]Adherence to therapy will be assessed by calculating attendance to planed appointments (physical therapy, medical appointments and LLL treatments)
- Female sexual function index questionnaire [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months. ]
- Pelvic floor hypertonicity measurements [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months. ]Pelvic floor muscle tonicity will be evaluated using manual palpation of the muscles by the physician.
- Brief Symptom Inventory-18 questionnaire (evaluating emotional symptoms) [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months. ]
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): NCT02892214
|Contact: Ahinoam Lev Sagie, MDfirstname.lastname@example.org|
|Merkaz Briot Haisha, Ramat Eshkol||Recruiting|
|Contact: Ahinoam Lev-Sagie, MD|