TriangleNCT03500419 · OUTCOME
Change in Erectile Function Domain of International Index of Erectile Function (IIEF)
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
Erectile function domain 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 | Source count |
|---|---|
| Control | 25 |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Control | -6.5 | Not reported | -21.5 | -2 | Not reported |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | 0 | Not reported | -7.5 | 4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -21.5
- upper Limit
- -2
- value
- -6.5
- group Id
- OG001
- lower Limit
- -7.5
- upper Limit
- 4
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 30
- units
- Participants
- description
- Erectile function domain 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
- 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
- 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 Erectile Function 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