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NCT00931528 · OUTCOME

Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF)

Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy · Source last updated 2018-02-14

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

Measure
MEAN
Unit
change in total IIEF
Interval / dispersion
Standard Deviation
Time frame
Baseline, week 30, and years 1 and 2 from start of treatment

What was measured

The IIEF is a validated 15-item for measuring patient-reported erectile function. A score of 0-5 is given to each of the 15 questions that examine 5 main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Domain scores are the sum of each item. The erectile function domain has 5 items with a score range of 1-30, orgasmic function has 2 items with a score range of 0-10, sexual desire has 2 items with a score range of 0-10, intercourse satisfaction has 3 items with a score range of 0-15, and overall satisfaction has 2 items with a score range of 2-10. Total score ranges from 0-70, with higher scores indicated better functioning. Change from baseline is calculated by subtracting baseline score from score at the time point of interest.

Analysis population: Eligible patients with IIEF at baseline and corresponding time points.

Groups in this outcome

Tadalafil

Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.

Placebo

Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.

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

Analysis denominator · Participants

GroupSource count
Tadalafil109
Placebo108

Reported measurements

Week 30

Analysis denominator · Participants

GroupSource count
Tadalafil70
Placebo58
Values in change in total IIEF · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tadalafil-8.215.4Not reportedNot reportedNot reported
Placebo-9.017.0Not reportedNot reportedNot reported
Year 1

Analysis denominator · Participants

GroupSource count
Tadalafil46
Placebo45
Values in change in total IIEF · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tadalafil-9.514.8Not reportedNot reportedNot reported
Placebo-10.518.4Not reportedNot reportedNot reported
Year 2

Analysis denominator · Participants

GroupSource count
Tadalafil49
Placebo45
Values in change in total IIEF · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tadalafil-9.715.7Not reportedNot reportedNot reported
Placebo-14.120.1Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    Week 30
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.97
    statistical Comment
    Significance level = 0.05
    statistical Method
    t-test, 2 sided
  2. group Description
    Year 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.99
    statistical Comment
    Significance level = 0.05
    statistical Method
    t-test, 2 sided
  3. group Description
    Year 2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.24
    statistical Comment
    Significance level = 0.05
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Description
    Week 30
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.97
    statistical Comment
    Significance level = 0.05
    statistical Method
    t-test, 2 sided
  2. group Description
    Year 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.99
    statistical Comment
    Significance level = 0.05
    statistical Method
    t-test, 2 sided
  3. group Description
    Year 2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.24
    statistical Comment
    Significance level = 0.05
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.4
        value
        -8.2
      2. group Id
        OG001
        spread
        17.0
        value
        -9.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        70
      2. group Id
        OG001
        value
        58
      units
      Participants
    title
    Week 30
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.8
        value
        -9.5
      2. group Id
        OG001
        spread
        18.4
        value
        -10.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        45
      units
      Participants
    title
    Year 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.7
        value
        -9.7
      2. group Id
        OG001
        spread
        20.1
        value
        -14.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        45
      units
      Participants
    title
    Year 2
denoms
  1. counts
    1. group Id
      OG000
      value
      109
    2. group Id
      OG001
      value
      108
    units
    Participants
description
The IIEF is a validated 15-item for measuring patient-reported erectile function. A score of 0-5 is given to each of the 15 questions that examine 5 main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Domain scores are the sum of each item. The erectile function domain has 5 items with a score range of 1-30, orgasmic function has 2 items with a score range of 0-10, sexual desire has 2 items with a score range of 0-10, intercourse satisfaction has 3 items with a score range of 0-15, and overall satisfaction has 2 items with a score range of 2-10. Total score ranges from 0-70, with higher scores indicated better functioning. Change from baseline is calculated by subtracting baseline score from score at the time point of interest.
dispersion Type
Standard Deviation
groups
  1. description
    Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
    id
    OG000
    title
    Tadalafil
  2. description
    Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
    id
    OG001
    title
    Placebo
param Type
MEAN
population Description
Eligible patients with IIEF at baseline and corresponding time points.
reporting Status
POSTED
time Frame
Baseline, week 30, and years 1 and 2 from start of treatment
title
Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF)
type
SECONDARY
unit Of Measure
change in total IIEF

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Preserved source evidence · Not medical advice