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NCT01444911 · OUTCOME

Change in Marinoff Scale 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

The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale: 0 = no pain with intercourse 1. = pain with intercourse that doesn't prevent the completion 2. = pain with intercourse requiring interruption or discontinuance 3. = pain with intercourse preventing any intercourse Difference in Marinoff scores reported, value at 6 months minus value at baseline.

Analysis population: Data for eleven subjects (2 from Standard of Care and 9 from VRP) was not collected at one or more study visits, and the change in scores could not be calculated.

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 Program7
Standard of Care11

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vaginal Renewal Program-0.857Not reported-20Not reported
Standard of Care-0.818Not reported-30Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2
        upper Limit
        0
        value
        -0.857
      2. group Id
        OG001
        lower Limit
        -3
        upper Limit
        0
        value
        -0.818
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      11
    units
    Participants
description
The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale: 0 = no pain with intercourse 1. = pain with intercourse that doesn't prevent the completion 2. = pain with intercourse requiring interruption or discontinuance 3. = pain with intercourse preventing any intercourse Difference in Marinoff scores reported, value at 6 months minus value at baseline.
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
population Description
Data for eleven subjects (2 from Standard of Care and 9 from VRP) was not collected at one or more study visits, and the change in scores could not be calculated.
reporting Status
POSTED
time Frame
At baseline and 6 months
title
Change in Marinoff Scale at 6 Months
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice