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Randomized CO2 vs Sham Laser Treatment of Provoked Vestibulodynia

Primary Purpose

Vestibulodynia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fractional CO2 Laser Treatment
Sham Laser Treatment
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibulodynia focused on measuring SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Fractional CO2 Laser, Sham Laser, Vulvodynia, PVD, Provoked vestibulodynia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 or older
  • Meets the 2015 terminology for the diagnosis of PVD, either type 1 (chronic vulvar pain since first attempts at intercourse and/or other penetrative activities) or type 2 (chronic vulvar pain with intercourse and/or other penetrative activities following a period of no vulvar pain)
  • Vulvar pain is localized to the vestibule and provoked by vaginal intercourse, other penetrative activities (e.g., tampon insertion, self-stimulation) and/or pressure exerted on the vestibule (e.g., due to tight-fitting clothing, cycling)
  • Vestibular pain is elicited with cotton-swab test during screening medical examination
  • Subject did not experience significant symptom improvement with prior therapy following a minimum of 2 standard-of-care treatments for PVD

Exclusion Criteria:

  • Currently receiving any type of treatment for PVD, including topical agents (e.g., lidocaine), oral medications (e.g., tricyclic antidepressants, anticonvulsants), pelvic floor physical therapy, psychotherapy, or locally injectable agents (e.g., botulinum toxin A)
  • Generalized vulvar pain
  • Unprovoked vulvar pain
  • History of vestibulectomy
  • Any medical, gynecologic, or iatrogenic condition (e.g., vulvar surgery) that could explain the presence of chronic vulvar pain (e.g., genitourinary syndrome of menopause, lichen sclerosus, vaginismus, significant pelvic organ prolapse, pudendal neuralgia)
  • Active vulvar and/or vaginal infection that is not due to bacterial vaginosis, Chlamydia, Trichomonads or Candida (if diagnosed with any of these infections, treat and re-evaluate after negative test of cure)
  • Active urinary tract infection
  • Currently pregnant or breastfeeding
  • Recent vaginal delivery (within 3 months post-partum)
  • Medical or psychiatric condition not under control
  • Scoring of 10 or above on the PHQ-9 and/or scoring 1 or above on the question asking about "thoughts that you would be better off dead, or of hurting yourself in some way"
  • History of treatment with fractional CO2 laser to the vulvar vestibule and/or vagina
  • History of radiation to vaginal/colorectal tissue, reconstructive pelvic surgery with "mesh kits", impaired wound healing or keloid formation, and/or thromboembolic condition

Sites / Locations

  • Wake Forest Baptist Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Fractional CO2 Laser Treatment

Sham Laser Treatment

Arm Description

Fractional CO2 laser will be applied to the entire vestibule, anteriorly to the fourchette, and laterally to the labia majora. This takes approximately 5 minutes to complete. A treatment cycle will consist of three laser sessions separated by 6 weeks +/- 1 week. The procedures will take place in the outpatient clinic. EMLA cream will be applied to the introitus for 20 minutes and wiped clean and dried prior to each laser session. Subjects will be advised to avoid intercourse for at least 3 days after each laser session because a mild inflammatory reaction may last up to 48 hours after a laser session. Topical lidocaine 5% ointment may be used for any vulvar discomfort post-procedure.

A treatment cycle will consist of three laser sessions separated by 6 weeks +/- 1 week. The procedures will take place in the outpatient clinic. Subjects assigned to sham laser will undergo the same pre-treatment with EMLA cream and will receive the same post-treatment instructions as the fractional CO2 laser subjects.

Outcomes

Primary Outcome Measures

Mean change from baseline in subjects' vulvar pain NRS scores
The primary outcome will be the mean change from baseline in subjects' vulvar pain NRS scores at 6, 12, 16, and 24 weeks post-randomization. At baseline and at each of these time points, subjects will be asked to rate their vulvar pain in the previous 4 weeks. The question posed to subjects will be worded as follows: "Please indicate, on a scale of 0 to 10, where 0 is no pain at all and 10 is the worst pain you have ever felt, the number that best describes the intensity of your vulvar pain with intercourse, on average, in the past 4 weeks. If intercourse has not been attempted, then indicate the number that best describes the intensity of your vulvar pain with other activities that elicit pain (for example, tampon insertion) in the past 4 weeks." NRS - Numeric Rating Scale - widely used clinically for the assessment of pain. A higher score would represent more pain and a poorer outcome than a lower score.

Secondary Outcome Measures

Mean change from baseline in subjects' scores on pain severity subscale VPAQ
The Vulvar Pain Assessment Questionnaire (VPAQ) was developed to assess the dimensions of the pain experience in studies of chronic pain. It consists of 6 primary (pain severity, emotional response, cognitive response, and interference with life, sexual function, and self-stimulation/penetration) and 3 supplementary subscales (pain quality, coping skills, and partner factors). The pain severity subscale of the VPAQ consists of 3 pairs of verbal rating scales (VRS) that test both pain intensity and pain affect (i.e., the emotional response generated by the feeling of pain). Each VRS is a 5-point scale with the following options: none=0, mild=1, moderate=2, severe=3, and worst possible=4, with a mean being calculated to produce the overall score for this subscale. The scale is 0-4 with 4 being the worst possible outcomes.
Mean change from baseline in subjects' scores on pain severity subscale SF-MPQ
The Short-Form McGill Pain Questionnaire (SF-MPQ), a well-validated measure of both pain affect and pain quality, consists of 15 pain descriptors rated on a 4-point VRS (none=0, mild=1, moderate=2, severe=3) to yield a total score on a scale from 0-60, where a lower score would represent less pain and a better outcome.
Mean change from baseline in subjects' scores on pain descriptors subscale VPAQ
The Vulvar Pain Assessment Questionnaire (VPAQ) was developed to assess the dimensions of the pain experience in studies of chronic pain. It consists of 6 primary (pain severity, emotional response, cognitive response, and interference with life, sexual function, and self-stimulation/penetration) and 3 supplementary subscales (pain quality, coping skills, and partner factors). The pain descriptors subscale of the VPAQ tests pain quality (i.e., how the pain is described in terms of sensory descriptors). It consists of 10 adjectives rated on a 5-point VRS (not at all=0, a little=1, somewhat=2, a lot=3, very much=4) to yield a total score from the mean of the adjectives to represent this subscale. The scale is 0-4 with 4 being the worst outcome.
Mean change from baseline in subjects' scores on the SF-36
The 36-item Short-Form Health Survey (SF-36) consists of 36 questions assessing physical functioning, role functioning difficulties caused by physical problems, bodily pain, general health, vitality, social functioning, role functioning difficulties caused by emotional problems, and mental health. Scoring the SF-36 is a two-step process. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. High scores are representative of a great health status and better outcomes, while low scores are representative of a poor health status.
Mean change from baseline in subjects' scores on the pain interference subscale of the BPI
The pain interference subscale of the Brief Pain Inventory (BPI), also a generic measure, assesses the degree to which a chronic pain condition interferes with 7 general life domains: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The scale goes from 0-10 with 10 being the worst. It assesses pain at its worst, lease, average, and now (current pain).The mean score for the interference of all of the activities for each severity item (worst, least, average, now) is calculated with a higher score (near 10) being a worse outcome.
Mean change from baseline in subjects' scores on the life interference subscale of the VPAQ
The Vulvar Pain Assessment Questionnaire (VPAQ) was developed to assess the dimensions of the pain experience in studies of chronic pain. It consists of 6 primary (pain severity, emotional response, cognitive response, and interference with life, sexual function, and self-stimulation/penetration) and 3 supplementary subscales (pain quality, coping skills, and partner factors). The life interference subscale of the VPAQ tests interference of pain with normal life activities. It consists of 11 everyday activities that could be interrupted by pain rated on a 5-point VRS (not at all=0, a little=1, somewhat=2, a lot=3, very much/I avoid because of pain=4) to yield a total score from the mean of the activities to represent this subscale. The scale is 0-4 with 4 being the worst outcome.
Mean change from baseline in subjects' scores on the life interference subscale of the FSFI
The Female Sexual Function Index (FSFI), the most-commonly used generic measure of sexual function in women in PVD studies, consists of 6 subscales related to sexual desire (2 Qs scale 1 worst - 5 best), arousal (4Qs 0 worst - 5 best), lubrication (4Qs 0 worst - 5 best), orgasm (3Qs 0 worst - 5 best), satisfaction (3Qs 0 worst - 5 best), and pain (3Qs 0 worst - 5 best). The sexual function interference subscale of the VPAQ assesses the impact of chronic vulvovaginal pain on sexual function. Higher scores indicate higher sexual functioning, with an overall range of 2-36.. A score of 26.55 has been clinically selected as the cut-off for sexual dysfunction, with a score lower than that indicating this problem.
Mean change from baseline in subjects' scores on the sexual function interference subscale of the VPAQ
The Vulvar Pain Assessment Questionnaire (VPAQ) was developed to assess the dimensions of the pain experience in studies of chronic pain. It consists of 6 primary (pain severity, emotional response, cognitive response, and interference with life, sexual function, and self-stimulation/penetration) and 3 supplementary subscales (pain quality, coping skills, and partner factors). The sexual function interference subscale of the VPAQ tests interference of pain with sexual activities. It consists of 10 sexual activities that could be interrupted by pain rated on a 5-point VRS (not at all=0, a little=1, somewhat=2, a lot=3, very much/I avoid because of pain=4) to yield a total score from the mean of the activities to represent this subscale. The scale is 0-4 with 4 being the worst outcome.
Mean change from baseline in subjects' scores on the sexual function interference subscale of the PHQ-9
The Patient Health Questionnaire-9 (PHQ-9) is 1 of 3 scales recommended by the National Institute for Health and Clinical Excellence for use in primary care to measure baseline depression severity and responsiveness to treatment. The scale goes from 0-27 with 0-4 indicating minimal depression with treatment unlikely to be necessary, 5-9 indicating mild depression and 10-14 indicating moderate depression with physicians using their clinical judgement for treatment (score 5-14) based on individual patient, 15-19 indicating moderately severe depression and 20-27 indicating severe depression warrant treatment for the depression (score >14). A higher score would represent a poorer outcome for this scale.
Comparison of percentages of subjects in each treatment arm endorsing improvement in symptoms on the PGIC scale
The Patient Global Impression of Change (PGIC) is a 7-point scale that rates the level of satisfaction with treatment (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse). 10 point scale with 0=much better, 5=no change, and 10=much worse. Scores less than 5 would represent good outcomes. .

Full Information

First Posted
December 26, 2017
Last Updated
June 6, 2019
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03390049
Brief Title
Randomized CO2 vs Sham Laser Treatment of Provoked Vestibulodynia
Official Title
Randomized Controlled Trial of Fractional CO2 Laser vs Sham Laser for Women With Provoked Vestibulodynia Who Have Failed Conservative Management
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Vulvodynia is a debilitating chronic vulvar pain lasting at least 3 months without a clear identifiable cause that is challenging to treat effectively. Vulvodynia is a common pain condition: its prevalence is estimated at 7-8% in women between the ages of 18 and 40. Vulvodynia that is provoked and localized to the vestibule (provoked vestibulodynia [PVD]) appears to be the most commonly seen in clinical practice. The current treatment approach for PVD follows a trial-and-error strategy from one intervention to another if symptoms fail to remit. Treatment options include reducing vulvar irritation (e.g., by stopping the use of detergents), topical agents (e.g., lidocaine), oral medications, pelvic floor physical therapy, psychotherapy, locally injectable agents (e.g., botulinum toxin A), and surgery (vestibulectomy). Despite the number of available treatment options, treatment failure is common. Fractional carbon-dioxide (CO2) laser is a technology widely used in dermatology for the treatment of various skin conditions. It has also been found to be an effective and safe treatment modality for symptoms of the genitourinary syndrome of menopause. A recent pilot study explored the use of fractional CO2 laser for the treatment of vestibulodynia in 37 subjects, 67.6% of which reported that their symptoms were "improved" or "very improved" after 3 fractional CO2 laser sessions. In addition, the subjects reported statistically-significant decreases in vulvar pain and dyspareunia scores. Though the results of this pilot study are promising, it was of small sample size and did not control for the placebo effect. In cases of PVD, the placebo effect has been found to have a significant impact on self-reported outcomes. Sham procedures, when performed correctly, can be ethically administered and can significantly reduce study bias. The primary aim of this study, therefore, is to assess the difference in vulvar pain intensity scores, at baseline and at 6, 12, 16, and 24 weeks post-randomization, in women with refractory PVD assigned to fractional CO2 laser vs sham laser. This study will provide information about the efficacy of this treatment modality in women with a challenging clinical condition. Hypothesis: Administration of 3 sessions of fractional carbon-dioxide laser to the vulvar vestibule of women with refractory provoked vestibulodynia will result in a clinically-significant greater reduction in vulvar pain intensity scores than placebo (sham laser).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibulodynia
Keywords
SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Fractional CO2 Laser, Sham Laser, Vulvodynia, PVD, Provoked vestibulodynia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Each subject will be assigned a study identification number, and demographic and clinical data will be recorded in REDCAP on de-identified data collection forms. The lead research coordinator will maintain the key linking the identification number to each subject in a locked, password-protected site. A random number generator in REDCAP will then randomly assign each subject to either fractional CO2 laser or sham laser. The physician administering the laser sessions will be blinded to treatment arm assignment.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fractional CO2 Laser Treatment
Arm Type
Active Comparator
Arm Description
Fractional CO2 laser will be applied to the entire vestibule, anteriorly to the fourchette, and laterally to the labia majora. This takes approximately 5 minutes to complete. A treatment cycle will consist of three laser sessions separated by 6 weeks +/- 1 week. The procedures will take place in the outpatient clinic. EMLA cream will be applied to the introitus for 20 minutes and wiped clean and dried prior to each laser session. Subjects will be advised to avoid intercourse for at least 3 days after each laser session because a mild inflammatory reaction may last up to 48 hours after a laser session. Topical lidocaine 5% ointment may be used for any vulvar discomfort post-procedure.
Arm Title
Sham Laser Treatment
Arm Type
Sham Comparator
Arm Description
A treatment cycle will consist of three laser sessions separated by 6 weeks +/- 1 week. The procedures will take place in the outpatient clinic. Subjects assigned to sham laser will undergo the same pre-treatment with EMLA cream and will receive the same post-treatment instructions as the fractional CO2 laser subjects.
Intervention Type
Device
Intervention Name(s)
Fractional CO2 Laser Treatment
Other Intervention Name(s)
Fractional microablative CO2 laser system
Intervention Description
After obtaining a negative urine pregnancy test, each subject assigned to the fractional CO2 laser treatment arm will undergo laser sessions with the fractional microablative CO2 laser system (SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy) using the flat vulvar probe with the following settings: dot power 26 Watts, dwell time 1000 μs, dot spacing 1000 μm, and smart stack parameter from 1 to 3. Stack 1 is used at baseline; stack 3 is used 6 and 12 weeks after.
Intervention Type
Device
Intervention Name(s)
Sham Laser Treatment
Other Intervention Name(s)
Fractional microablative CO2 laser system
Intervention Description
After obtaining a negative urine pregnancy test, each subject assigned to the sham laser treatment arm will undergo laser sessions with the fractional microablative CO2 laser system (SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy) using the flat vulvar probe. However, these sham laser sessions will administer no fractional CO2 laser energy. To increase the likelihood that subjects assigned to sham laser remain blinded to treatment arm assignment during the study, MonaLisa Touch will provide a software package with settings that allow for reproduction of the sounds generated during a regular fractional CO2 laser session but using 0 Watts of power.
Primary Outcome Measure Information:
Title
Mean change from baseline in subjects' vulvar pain NRS scores
Description
The primary outcome will be the mean change from baseline in subjects' vulvar pain NRS scores at 6, 12, 16, and 24 weeks post-randomization. At baseline and at each of these time points, subjects will be asked to rate their vulvar pain in the previous 4 weeks. The question posed to subjects will be worded as follows: "Please indicate, on a scale of 0 to 10, where 0 is no pain at all and 10 is the worst pain you have ever felt, the number that best describes the intensity of your vulvar pain with intercourse, on average, in the past 4 weeks. If intercourse has not been attempted, then indicate the number that best describes the intensity of your vulvar pain with other activities that elicit pain (for example, tampon insertion) in the past 4 weeks." NRS - Numeric Rating Scale - widely used clinically for the assessment of pain. A higher score would represent more pain and a poorer outcome than a lower score.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Mean change from baseline in subjects' scores on pain severity subscale VPAQ
Description
The Vulvar Pain Assessment Questionnaire (VPAQ) was developed to assess the dimensions of the pain experience in studies of chronic pain. It consists of 6 primary (pain severity, emotional response, cognitive response, and interference with life, sexual function, and self-stimulation/penetration) and 3 supplementary subscales (pain quality, coping skills, and partner factors). The pain severity subscale of the VPAQ consists of 3 pairs of verbal rating scales (VRS) that test both pain intensity and pain affect (i.e., the emotional response generated by the feeling of pain). Each VRS is a 5-point scale with the following options: none=0, mild=1, moderate=2, severe=3, and worst possible=4, with a mean being calculated to produce the overall score for this subscale. The scale is 0-4 with 4 being the worst possible outcomes.
Time Frame
24 weeks
Title
Mean change from baseline in subjects' scores on pain severity subscale SF-MPQ
Description
The Short-Form McGill Pain Questionnaire (SF-MPQ), a well-validated measure of both pain affect and pain quality, consists of 15 pain descriptors rated on a 4-point VRS (none=0, mild=1, moderate=2, severe=3) to yield a total score on a scale from 0-60, where a lower score would represent less pain and a better outcome.
Time Frame
24 weeks
Title
Mean change from baseline in subjects' scores on pain descriptors subscale VPAQ
Description
The Vulvar Pain Assessment Questionnaire (VPAQ) was developed to assess the dimensions of the pain experience in studies of chronic pain. It consists of 6 primary (pain severity, emotional response, cognitive response, and interference with life, sexual function, and self-stimulation/penetration) and 3 supplementary subscales (pain quality, coping skills, and partner factors). The pain descriptors subscale of the VPAQ tests pain quality (i.e., how the pain is described in terms of sensory descriptors). It consists of 10 adjectives rated on a 5-point VRS (not at all=0, a little=1, somewhat=2, a lot=3, very much=4) to yield a total score from the mean of the adjectives to represent this subscale. The scale is 0-4 with 4 being the worst outcome.
Time Frame
24 weeks
Title
Mean change from baseline in subjects' scores on the SF-36
Description
The 36-item Short-Form Health Survey (SF-36) consists of 36 questions assessing physical functioning, role functioning difficulties caused by physical problems, bodily pain, general health, vitality, social functioning, role functioning difficulties caused by emotional problems, and mental health. Scoring the SF-36 is a two-step process. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. High scores are representative of a great health status and better outcomes, while low scores are representative of a poor health status.
Time Frame
24 weeks
Title
Mean change from baseline in subjects' scores on the pain interference subscale of the BPI
Description
The pain interference subscale of the Brief Pain Inventory (BPI), also a generic measure, assesses the degree to which a chronic pain condition interferes with 7 general life domains: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The scale goes from 0-10 with 10 being the worst. It assesses pain at its worst, lease, average, and now (current pain).The mean score for the interference of all of the activities for each severity item (worst, least, average, now) is calculated with a higher score (near 10) being a worse outcome.
Time Frame
24 weeks
Title
Mean change from baseline in subjects' scores on the life interference subscale of the VPAQ
Description
The Vulvar Pain Assessment Questionnaire (VPAQ) was developed to assess the dimensions of the pain experience in studies of chronic pain. It consists of 6 primary (pain severity, emotional response, cognitive response, and interference with life, sexual function, and self-stimulation/penetration) and 3 supplementary subscales (pain quality, coping skills, and partner factors). The life interference subscale of the VPAQ tests interference of pain with normal life activities. It consists of 11 everyday activities that could be interrupted by pain rated on a 5-point VRS (not at all=0, a little=1, somewhat=2, a lot=3, very much/I avoid because of pain=4) to yield a total score from the mean of the activities to represent this subscale. The scale is 0-4 with 4 being the worst outcome.
Time Frame
24 weeks
Title
Mean change from baseline in subjects' scores on the life interference subscale of the FSFI
Description
The Female Sexual Function Index (FSFI), the most-commonly used generic measure of sexual function in women in PVD studies, consists of 6 subscales related to sexual desire (2 Qs scale 1 worst - 5 best), arousal (4Qs 0 worst - 5 best), lubrication (4Qs 0 worst - 5 best), orgasm (3Qs 0 worst - 5 best), satisfaction (3Qs 0 worst - 5 best), and pain (3Qs 0 worst - 5 best). The sexual function interference subscale of the VPAQ assesses the impact of chronic vulvovaginal pain on sexual function. Higher scores indicate higher sexual functioning, with an overall range of 2-36.. A score of 26.55 has been clinically selected as the cut-off for sexual dysfunction, with a score lower than that indicating this problem.
Time Frame
24 weeks
Title
Mean change from baseline in subjects' scores on the sexual function interference subscale of the VPAQ
Description
The Vulvar Pain Assessment Questionnaire (VPAQ) was developed to assess the dimensions of the pain experience in studies of chronic pain. It consists of 6 primary (pain severity, emotional response, cognitive response, and interference with life, sexual function, and self-stimulation/penetration) and 3 supplementary subscales (pain quality, coping skills, and partner factors). The sexual function interference subscale of the VPAQ tests interference of pain with sexual activities. It consists of 10 sexual activities that could be interrupted by pain rated on a 5-point VRS (not at all=0, a little=1, somewhat=2, a lot=3, very much/I avoid because of pain=4) to yield a total score from the mean of the activities to represent this subscale. The scale is 0-4 with 4 being the worst outcome.
Time Frame
24 weeks
Title
Mean change from baseline in subjects' scores on the sexual function interference subscale of the PHQ-9
Description
The Patient Health Questionnaire-9 (PHQ-9) is 1 of 3 scales recommended by the National Institute for Health and Clinical Excellence for use in primary care to measure baseline depression severity and responsiveness to treatment. The scale goes from 0-27 with 0-4 indicating minimal depression with treatment unlikely to be necessary, 5-9 indicating mild depression and 10-14 indicating moderate depression with physicians using their clinical judgement for treatment (score 5-14) based on individual patient, 15-19 indicating moderately severe depression and 20-27 indicating severe depression warrant treatment for the depression (score >14). A higher score would represent a poorer outcome for this scale.
Time Frame
24 weeks
Title
Comparison of percentages of subjects in each treatment arm endorsing improvement in symptoms on the PGIC scale
Description
The Patient Global Impression of Change (PGIC) is a 7-point scale that rates the level of satisfaction with treatment (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse). 10 point scale with 0=much better, 5=no change, and 10=much worse. Scores less than 5 would represent good outcomes. .
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 or older Meets the 2015 terminology for the diagnosis of PVD, either type 1 (chronic vulvar pain since first attempts at intercourse and/or other penetrative activities) or type 2 (chronic vulvar pain with intercourse and/or other penetrative activities following a period of no vulvar pain) Vulvar pain is localized to the vestibule and provoked by vaginal intercourse, other penetrative activities (e.g., tampon insertion, self-stimulation) and/or pressure exerted on the vestibule (e.g., due to tight-fitting clothing, cycling) Vestibular pain is elicited with cotton-swab test during screening medical examination Subject did not experience significant symptom improvement with prior therapy following a minimum of 2 standard-of-care treatments for PVD Exclusion Criteria: Currently receiving any type of treatment for PVD, including topical agents (e.g., lidocaine), oral medications (e.g., tricyclic antidepressants, anticonvulsants), pelvic floor physical therapy, psychotherapy, or locally injectable agents (e.g., botulinum toxin A) Generalized vulvar pain Unprovoked vulvar pain History of vestibulectomy Any medical, gynecologic, or iatrogenic condition (e.g., vulvar surgery) that could explain the presence of chronic vulvar pain (e.g., genitourinary syndrome of menopause, lichen sclerosus, vaginismus, significant pelvic organ prolapse, pudendal neuralgia) Active vulvar and/or vaginal infection that is not due to bacterial vaginosis, Chlamydia, Trichomonads or Candida (if diagnosed with any of these infections, treat and re-evaluate after negative test of cure) Active urinary tract infection Currently pregnant or breastfeeding Recent vaginal delivery (within 3 months post-partum) Medical or psychiatric condition not under control Scoring of 10 or above on the PHQ-9 and/or scoring 1 or above on the question asking about "thoughts that you would be better off dead, or of hurting yourself in some way" History of treatment with fractional CO2 laser to the vulvar vestibule and/or vagina History of radiation to vaginal/colorectal tissue, reconstructive pelvic surgery with "mesh kits", impaired wound healing or keloid formation, and/or thromboembolic condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine A Matthews, MD
Organizational Affiliation
Professor or Ob/Gyn and Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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
PubMed Identifier
24080300
Citation
Harlow BL, Kunitz CG, Nguyen RH, Rydell SA, Turner RM, MacLehose RF. Prevalence of symptoms consistent with a diagnosis of vulvodynia: population-based estimates from 2 geographic regions. Am J Obstet Gynecol. 2014 Jan;210(1):40.e1-8. doi: 10.1016/j.ajog.2013.09.033. Epub 2013 Sep 28.
Results Reference
background
PubMed Identifier
24833921
Citation
Sadownik LA. Etiology, diagnosis, and clinical management of vulvodynia. Int J Womens Health. 2014 May 2;6:437-49. doi: 10.2147/IJWH.S37660. eCollection 2014.
Results Reference
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PubMed Identifier
27312009
Citation
Falsetta ML, Foster DC, Bonham AD, Phipps RP. A review of the available clinical therapies for vulvodynia management and new data implicating proinflammatory mediators in pain elicitation. BJOG. 2017 Jan;124(2):210-218. doi: 10.1111/1471-0528.14157. Epub 2016 Jun 17.
Results Reference
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PubMed Identifier
25608269
Citation
Salvatore S, Leone Roberti Maggiore U, Athanasiou S, Origoni M, Candiani M, Calligaro A, Zerbinati N. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause. 2015 Aug;22(8):845-9. doi: 10.1097/GME.0000000000000401.
Results Reference
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PubMed Identifier
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Citation
Sokol ER, Karram MM. An assessment of the safety and efficacy of a fractional CO2 laser system for the treatment of vulvovaginal atrophy. Menopause. 2016 Oct;23(10):1102-7. doi: 10.1097/GME.0000000000000700.
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Randomized CO2 vs Sham Laser Treatment of Provoked Vestibulodynia

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