Skip to content
← Full study record

NCT03500419 · OUTCOME

Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF)

Penile Length Maintenance Post-Prostatectomy · Source last updated 2021-10-20

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

Measure
MEDIAN
Unit
units on a scale
Interval / dispersion
Inter-Quartile Range
Time frame
Baseline, 6 months

What was measured

Intercourse satisfaction will be measured by using the International Index of Erectile Function (IIEF) questionnaire. IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.

Analysis population: 6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm. Negative denotes loss of function.

Groups in this outcome

Control

No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes. No treatment: Control group. No treatment was given for the 6 months post-prostatectomy

PTT 1-2x Daily x 5-7 Days/Week x 5 Months

Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months. RestoreX: PTT - Penile traction therapy in the straight position.

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

Analysis denominator · Participants

GroupSource count
Control25
PTT 1-2x Daily x 5-7 Days/Week x 5 Months30

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Control-3.5Not reported-7.00Not reported
PTT 1-2x Daily x 5-7 Days/Week x 5 Months1Not reported-27Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -7.0
        upper Limit
        0
        value
        -3.5
      2. group Id
        OG001
        lower Limit
        -2
        upper Limit
        7
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      30
    units
    Participants
description
Intercourse satisfaction will be measured by using the International Index of Erectile Function (IIEF) questionnaire. IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
dispersion Type
Inter-Quartile Range
groups
  1. description
    No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes. No treatment: Control group. No treatment was given for the 6 months post-prostatectomy
    id
    OG000
    title
    Control
  2. description
    Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months. RestoreX: PTT - Penile traction therapy in the straight position.
    id
    OG001
    title
    PTT 1-2x Daily x 5-7 Days/Week x 5 Months
param Type
MEDIAN
population Description
6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm. Negative denotes loss of function.
reporting Status
POSTED
time Frame
Baseline, 6 months
title
Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF)
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice