Vulvar Intraepithelial Neoplasia (VIN)
Conditions
Brief summary
The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or ultrasonic aspiration.
Detailed description
Incidence of Vulvar Intraepithelial Neoplasia (VIN) is increasing among women and there still lacks a standard of care for optimal treatment. Current treatment options aim to treat the symptoms associated with VIN and result in a high recurrence rate. Due to the high reoccurrence rate and the nature of the current treatments, a more effective treatment option is warranted. An effective treatment that targets only the diseased areas could potentially decrease recurrence rates. Additionally, a more conservative treatment modality could contribute to reduced risks of scarring, discomfort, and psychosocial and sexual distraught. The researchers hypothesize that treatment for VIN with ultrasonic aspiration will have a 60% reduction in recurrence rates over 12 months as compared to CO2 laser aspiration. This study will employ a randomized controlled trial (RCT) design. This is a phase III study to determine the effectiveness of a more targeted treatment therapy for VIN (comparing ultrasonic aspiration versus CO2 laser ablation). Potential participants will be identified through the gynecological clinical practices following diagnosis of high grade VIN and will be randomized (1:1) to one of the treatment therapies. Randomization will be stratified for multi-focal disease and Human Papillomavirus (HPV) status. Both the Sonopet Ultrasonic Aspirator and the CO2 laser ablation devices are FDA approved devices for the treatment of vulvar dysplasia.
Interventions
DEVICESonopet Ultrasonic Aspirator
To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
DEVICECO2 Laser Ablation
To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
Sponsors
Stryker Instruments
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Women 18-89 years old * Women diagnosed with high-grade VIN (diagnosed by pathology) * Women referred for vulva sparing treatment for dysplasia * Women available for follow-up of treatment for 12 months
Exclusion criteria
* Women who are pregnant * Women with low-grade VIN dysplasia (diagnosed by pathology) * Women with vaginal intraepithelial neoplasia(VAIN) * Women requiring vulvectomy for treatment * Women unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrence of Dysplasia | 12 months | Number of participants with recurrence of dysplasia time point 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Scarring | 6 weeks | Physical evaluation for scarring |
| Changes in Sexual Function | Baseline (enrollment), 12 months | Evaluated by Female Sexual Function Index Scale Title: Female Sexual Function Index (FSFI) Minimum value: 2.0 Maximum value: 36.0 a score of 0 in any domain correlates to no sexual activity. a score of 0 in any domain correlates to no sexual activity in that domain alone, and is not indicative of the total score. Lower scores indicate worse sexual function. |
| Changes in Mental and Physical Wellness | Baseline (enrollment), End of Study (12 months) | Evaluated by Functional Assessment of Cancer Therapy - Vulva (FACT-V) health survey for vulva disease Scale Title: Functional Assessment of Cancer Therapy - Vulva (FACT-V) High score correlates to better quality of life. This survey uses a 5-point Likert type scale. Minimum score: 0 Maximum score: 184 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sonopet Ultrasonic Aspirator Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
Sonopet Ultrasonic Aspirator: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation | 19 |
| CO2 Laser Ablation Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
CO2 Laser Ablation: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation | 28 |
| Total | 47 |
Baseline characteristics
| Characteristic | Sonopet Ultrasonic Aspirator | CO2 Laser Ablation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 10 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 18 Participants | 34 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 27 Participants | 44 Participants |
| Region of Enrollment United States | 19 Participants | 28 Participants | 47 Participants |
| Sex: Female, Male Female | 19 Participants | 28 Participants | 47 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 28 |
| other Total, other adverse events | 12 / 19 | 18 / 28 |
| serious Total, serious adverse events | 0 / 19 | 0 / 28 |
Outcome results
Primary
Number of Participants With Recurrence of Dysplasia
Number of participants with recurrence of dysplasia time point 12 months
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sonopet Ultrasonic Aspirator | Number of Participants With Recurrence of Dysplasia | 5 Participants |
| CO2 Laser Ablation | Number of Participants With Recurrence of Dysplasia | 8 Participants |
Secondary
Changes in Mental and Physical Wellness
Evaluated by Functional Assessment of Cancer Therapy - Vulva (FACT-V) health survey for vulva disease Scale Title: Functional Assessment of Cancer Therapy - Vulva (FACT-V) High score correlates to better quality of life. This survey uses a 5-point Likert type scale. Minimum score: 0 Maximum score: 184
Time frame: Baseline (enrollment), End of Study (12 months)
Population: all surveys at all timepoints were optional. Some participants completed all surveys, some completed only baseline surveys and some only completed end of study surveys. This is why the population varies between timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sonopet Ultrasonic Aspirator | Changes in Mental and Physical Wellness | Baseline | 155.6 score on a scale | Standard Deviation 29.8 |
| Sonopet Ultrasonic Aspirator | Changes in Mental and Physical Wellness | End of Study | 147 score on a scale | Standard Deviation 26.4 |
| CO2 Laser Ablation | Changes in Mental and Physical Wellness | Baseline | 145 score on a scale | Standard Deviation 29.1 |
| CO2 Laser Ablation | Changes in Mental and Physical Wellness | End of Study | 156.5 score on a scale | Standard Deviation 20.9 |
Secondary
Changes in Sexual Function
Evaluated by Female Sexual Function Index Scale Title: Female Sexual Function Index (FSFI) Minimum value: 2.0 Maximum value: 36.0 a score of 0 in any domain correlates to no sexual activity. a score of 0 in any domain correlates to no sexual activity in that domain alone, and is not indicative of the total score. Lower scores indicate worse sexual function.
Time frame: Baseline (enrollment), 12 months
Population: all surveys at all timepoints were optional. Some participants completed all surveys, some completed only baseline surveys and some only completed end of study surveys. This is why the population varies between timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sonopet Ultrasonic Aspirator | Changes in Sexual Function | Baseline | 14.9 score on a scale | Standard Deviation 12.3 |
| Sonopet Ultrasonic Aspirator | Changes in Sexual Function | End of Study | 10.3 score on a scale | Standard Deviation 11.3 |
| CO2 Laser Ablation | Changes in Sexual Function | Baseline | 10.9 score on a scale | Standard Deviation 9.5 |
| CO2 Laser Ablation | Changes in Sexual Function | End of Study | 19.8 score on a scale | Standard Deviation 10.1 |
Secondary
Number of Participants With Scarring
Physical evaluation for scarring
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sonopet Ultrasonic Aspirator | Number of Participants With Scarring | 6 Participants |
| CO2 Laser Ablation | Number of Participants With Scarring | 12 Participants |