Trial · NCT07877077
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Flaccid Penile Circumference at Month 6 | Baseline and Month 6 | Flaccid penile circumference will be measured in millimeters at the distal, middle, and proximal penile shaft using a non-stretch measuring tape under standardized conditions. The arithmetic mean of the three measurements will be recorded as the average flaccid penile circumference. Change will be calculated as the Month 6 value minus the baseline value. |
| Secondary | Change From Baseline in Average Flaccid Penile Circumference at Other Follow-up Time Points | Baseline, immediately after treatment, Month 3, and Month 12 | Average flaccid penile circumference will be calculated as the arithmetic mean of distal, middle, and proximal shaft circumference measurements. Change at each follow-up time point will be calculated as the follow-up value minus the baseline value and reported in millimeters. |
| Secondary | Participant-Reported Residual Filler Durability Score | Month 3, Month 6, and Month 12 | Participants will estimate the amount of residual filler using a 5-level ordinal scale: 0=no residual filler, 1=approximately 25% remaining, 2=approximately 50% remaining, 3=approximately 75% remaining, and 4=approximately 100% remaining. Higher scores indicate greater perceived filler durability. |
| Secondary | Change From Baseline in Penile Appearance Satisfaction Score | Baseline, Month 3, Month 6, and Month 12 | Penile appearance satisfaction will be rated on a 5-point ordinal scale: 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, and 5=very satisfied. Higher scores indicate greater satisfaction. Change will be calculated as the follow-up score minus the baseline score. |
| Secondary | Change From Baseline in Sexual Life Satisfaction Score | Baseline, Month 3, Month 6, and Month 12 | Sexual life satisfaction will be rated on a 5-point ordinal scale: 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, and 5=very satisfied. Higher scores indicate greater satisfaction. Change will be calculated as the follow-up score minus the baseline score. |
| Secondary | Change From Baseline in International Index of Erectile Function-5 (IIEF-5) Score | Baseline, Month 3, Month 6, and Month 12 | Erectile function will be assessed using the validated 5-item International Index of Erectile Function (IIEF-5). The total score ranges from 5 to 25, with higher scores indicating better erectile function and therefore a better outcome. Change from baseline will be calculated as the follow-up score minus the baseline score. |
| Secondary | Change From Baseline in Premature Ejaculation Diagnostic Tool (PEDT) Score | Baseline, Month 3, Month 6, and Month 12 | Ejaculatory function will be assessed using the validated 5-item Premature Ejaculation Diagnostic Tool (PEDT). Total scores range from 0 to 20, with higher scores indicating a greater likelihood or severity of premature ejaculation. Change will be calculated as the follow-up score minus the baseline score. |
| Secondary | Number of Participants With Adverse Events Through Month 12 | From treatment through Month 12 | Adverse events will be recorded according to onset, severity, relationship to treatment, and outcome. The number and proportion of participants experiencing adverse events will be summarized. Serious adverse events will be reported separately and described narratively. |
| Secondary | Inter-rater Reliability of Penile Circumference Measurements Assessed by Intraclass Correlation Coefficient | Month 12 | Agreement between two independent evaluators will be assessed using a two-way random-effects, absolute-agreement intraclass correlation coefficient \[ICC(2,1)\] with a 95% confidence interval. |
| Secondary | Proportion of Participants Lost to Follow-up by Month 12 | From enrollment through Month 12 | The number and proportion of enrolled participants who do not complete the planned follow-up through Month 12 will be reported. |
| Secondary | Proportion of Participants Without Major Protocol Deviations | From enrollment through Month 12 | Protocol adherence will be assessed as the proportion of participants who complete the study without a major protocol deviation. The protocol-compliant analysis set will include participants without major protocol deviations. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07877077/registered