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NCT02470897 · OUTCOME

Change in International Index of Erectile Dysfunction Questionnaire (IIEF-5)

Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate Cancer · Source last updated 2026-10-13

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
at Baseline, 1 year, and 2 years

What was measured

The IIEF-5 questionnaire has a total score of 1-25 where 1-7 is considered severe erectile dysfunction (ED), 8-11 is moderate ED, 12-16 is mild-moderate ED, 17-21 is mild ED, and 22-25 is no ED. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.

Analysis population: Inadequate survey completion at specific time points

Groups in this outcome

Arm A (Moderate Dose SBRT With SIB)

Patients undergo 5 fractions of moderate dose SBRT with SIB every other day for 10 days following urethral-sparing IMRT planning. SBRT: 8.0Gy escalated dose Radiation Therapy Treatment Planning and Simulation: Undergo urethral-sparing IMRT planning SBRT: Undergo moderate dose SBRT with SIB

Arm B (Uniform Dose SBRT)

Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning. SBRT: 7.5Gy conventional dose Radiation Therapy Treatment Planning and Simulation: Undergo urethral-sparing IMRT planning SBRT: Undergo uniform dose SBRT

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

Analysis denominator · Participants

GroupSource count
Arm A (Moderate Dose SBRT With SIB)100
Arm B (Uniform Dose SBRT)15

Reported measurements

baseline

Analysis denominator · Participants

GroupSource count
Arm A (Moderate Dose SBRT With SIB)94
Arm B (Uniform Dose SBRT)12
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Moderate Dose SBRT With SIB)15.066.50Not reportedNot reportedNot reported
Arm B (Uniform Dose SBRT)15.336.87Not reportedNot reportedNot reported
1 year

Analysis denominator · Participants

GroupSource count
Arm A (Moderate Dose SBRT With SIB)82
Arm B (Uniform Dose SBRT)12
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Moderate Dose SBRT With SIB)13.156.99Not reportedNot reportedNot reported
Arm B (Uniform Dose SBRT)10.085.68Not reportedNot reportedNot reported
2 years

Analysis denominator · Participants

GroupSource count
Arm A (Moderate Dose SBRT With SIB)80
Arm B (Uniform Dose SBRT)12
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Moderate Dose SBRT With SIB)12.996.96Not reportedNot reportedNot reported
Arm B (Uniform Dose SBRT)11.337.15Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.50
        value
        15.06
      2. group Id
        OG001
        spread
        6.87
        value
        15.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.99
        value
        13.15
      2. group Id
        OG001
        spread
        5.68
        value
        10.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        82
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    1 year
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.96
        value
        12.99
      2. group Id
        OG001
        spread
        7.15
        value
        11.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        80
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    2 years
denoms
  1. counts
    1. group Id
      OG000
      value
      100
    2. group Id
      OG001
      value
      15
    units
    Participants
description
The IIEF-5 questionnaire has a total score of 1-25 where 1-7 is considered severe erectile dysfunction (ED), 8-11 is moderate ED, 12-16 is mild-moderate ED, 17-21 is mild ED, and 22-25 is no ED. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
dispersion Type
Standard Deviation
groups
  1. description
    Patients undergo 5 fractions of moderate dose SBRT with SIB every other day for 10 days following urethral-sparing IMRT planning. SBRT: 8.0Gy escalated dose Radiation Therapy Treatment Planning and Simulation: Undergo urethral-sparing IMRT planning SBRT: Undergo moderate dose SBRT with SIB
    id
    OG000
    title
    Arm A (Moderate Dose SBRT With SIB)
  2. description
    Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning. SBRT: 7.5Gy conventional dose Radiation Therapy Treatment Planning and Simulation: Undergo urethral-sparing IMRT planning SBRT: Undergo uniform dose SBRT
    id
    OG001
    title
    Arm B (Uniform Dose SBRT)
param Type
MEAN
population Description
Inadequate survey completion at specific time points
reporting Status
POSTED
time Frame
at Baseline, 1 year, and 2 years
title
Change in International Index of Erectile Dysfunction Questionnaire (IIEF-5)
type
SECONDARY
unit Of Measure
score on a scale

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Preserved source evidence · Not medical advice