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NCT01444911 · OUTCOME

Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months

Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction · Source last updated 2019-12-09

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

Measure
MEAN
Unit
Units on a scale
Interval / dispersion
Full Range
Time frame
At baseline and 6 months

What was measured

Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported.

Groups in this outcome

Vaginal Renewal Program

Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.

Standard of Care

This will consist of still vaginal dilator and/or lubricant. Vaginal Dilator: Still vaginal dilator with lubricant.

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

Analysis denominator · Participants

GroupSource count
Vaginal Renewal Program8
Standard of Care13

Reported measurements

Source class 1
Values in Units on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vaginal Renewal Program5.575Not reported-8.414Not reported
Standard of Care6.069Not reported-4.020.8Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.89
    statistical Method
    ANOVA
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.89
    statistical Method
    ANOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -8.4
        upper Limit
        14
        value
        5.575
      2. group Id
        OG001
        lower Limit
        -4.0
        upper Limit
        20.8
        value
        6.069
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      13
    units
    Participants
description
Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported.
dispersion Type
Full Range
groups
  1. description
    Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
    id
    OG000
    title
    Vaginal Renewal Program
  2. description
    This will consist of still vaginal dilator and/or lubricant. Vaginal Dilator: Still vaginal dilator with lubricant.
    id
    OG001
    title
    Standard of Care
param Type
MEAN
reporting Status
POSTED
time Frame
At baseline and 6 months
title
Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months
type
PRIMARY
unit Of Measure
Units on a scale

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

Preserved source evidence · Not medical advice