TriangleNCT04148651 · OUTCOME
Change From Baseline in Sexual Function on the Female Sexual Function Index (FSFI) at 3 Months and 6 Months After the Final Treatment
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
- Standard Error
- Time frame
- Baseline and 3 months and 6 months after the final treatment
What was measured
Female Sexual Function Index (FSFI) is a validated, self-reported 19-item questionnaire that assesses domains of sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain. The aggregated FSFI score is a sum of weighted answers for each of the 19 items in the questionnaire, with a maximum total score possible of 36.0 (high level of sexual functional) and minimum score of 2.0 (low level of sexual functional). Change = (Follow-up score - Baseline score). Mean change was calculated for all scores at the 3- and 6-month follow-ups.
Analysis population: At Baseline, 12 patients completed FSFI questionnaires. At the 3-month visit, 11 subjects completed the FSFI (one subject missed the visit). At the 6-month follow-up, 12 subjects completed the FSFI (one subject missed her visit but provided her self-assessments remotely).
Groups in this outcome
CO2RE® Treatment
All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen. The CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN).
| Group | Source count |
|---|---|
| CO2RE® Treatment | 12 |
Reported measurements
Mean Change in FSFI At the 3-Month Follow-up
| Group | Source count |
|---|---|
| CO2RE® Treatment | 11 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CO2RE® Treatment | 4.06 | 2.25 | Not reported | Not reported | Not reported |
Mean Change in FSFI At the 6-Month Follow-up
| Group | Source count |
|---|---|
| CO2RE® Treatment | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CO2RE® Treatment | 4.53 | 2.41 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.25
- value
- 4.06
- denoms
- counts
- group Id
- OG000
- value
- 11
- units
- Participants
- title
- Mean Change in FSFI At the 3-Month Follow-up
- categories
- measurements
- group Id
- OG000
- spread
- 2.41
- value
- 4.53
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- title
- Mean Change in FSFI At the 6-Month Follow-up
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- Female Sexual Function Index (FSFI) is a validated, self-reported 19-item questionnaire that assesses domains of sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain. The aggregated FSFI score is a sum of weighted answers for each of the 19 items in the questionnaire, with a maximum total score possible of 36.0 (high level of sexual functional) and minimum score of 2.0 (low level of sexual functional). Change = (Follow-up score - Baseline score). Mean change was calculated for all scores at the 3- and 6-month follow-ups.
- dispersion Type
- Standard Error
- groups
- description
- All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen. The CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN).
- id
- OG000
- title
- CO2RE® Treatment
- param Type
- MEAN
- population Description
- At Baseline, 12 patients completed FSFI questionnaires. At the 3-month visit, 11 subjects completed the FSFI (one subject missed the visit). At the 6-month follow-up, 12 subjects completed the FSFI (one subject missed her visit but provided her self-assessments remotely).
- reporting Status
- POSTED
- time Frame
- Baseline and 3 months and 6 months after the final treatment
- title
- Change From Baseline in Sexual Function on the Female Sexual Function Index (FSFI) at 3 Months and 6 Months After the Final Treatment
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice