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NCT02875561 · OUTCOME

Changes in Sexual Function

Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia · Source last updated 2023-11-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline (enrollment), 12 months

What was measured

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.

Analysis 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.

Groups in this outcome

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

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Sonopet Ultrasonic Aspirator15
CO2 Laser Ablation24

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Sonopet Ultrasonic Aspirator15
CO2 Laser Ablation24
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sonopet Ultrasonic Aspirator14.912.3Not reportedNot reportedNot reported
CO2 Laser Ablation10.99.5Not reportedNot reportedNot reported
End of Study

Analysis denominator · Participants

GroupSource count
Sonopet Ultrasonic Aspirator8
CO2 Laser Ablation11
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sonopet Ultrasonic Aspirator10.311.3Not reportedNot reportedNot reported
CO2 Laser Ablation19.810.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.3
        value
        14.9
      2. group Id
        OG001
        spread
        9.5
        value
        10.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.3
        value
        10.3
      2. group Id
        OG001
        spread
        10.1
        value
        19.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    End of Study
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      24
    units
    Participants
description
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.
dispersion Type
Standard Deviation
groups
  1. description
    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
    id
    OG000
    title
    Sonopet Ultrasonic Aspirator
  2. description
    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
    id
    OG001
    title
    CO2 Laser Ablation
param Type
MEAN
population Description
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.
reporting Status
POSTED
time Frame
Baseline (enrollment), 12 months
title
Changes in Sexual Function
type
SECONDARY
unit Of Measure
score on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice