Treatment Response to Xiaflex for Men With Peyronie's Disease
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|ClinicalTrials.gov Identifier: NCT03774264|
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : August 25, 2020
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Treatment Response to Xiaflex Based on Ultrasound Characterization of Plaque for Men With Peyronie's Disease|
|Actual Study Start Date :||September 2, 2018|
|Estimated Primary Completion Date :||December 2, 2021|
|Estimated Study Completion Date :||December 2, 2021|
Patients will be evaluated in our urology clinic at baseline for possible inclusion in our study. All patients at baseline evaluation will be evaluated for duration of symptoms, relationship stability, IIEF and PDQ. All patients will obtain a penile Doppler ultrasound with the aid of a vasoactive substance by a specially trained technician. During this visit, plaque measurements will be taken: location of plaque, distance of plaque from the tip of the penis, degree of curvature measured by goniometer.
Ultrasound characteristics will be documented: Type (Type 1: The plaque appears as a thickening of the tunica albuginea without acoustic shadowing. Type 2: A moderately calcified plaque with a typical ultrasound shadow. Type 3: A severely calcified plaque with typical ultrasound shadowing) and Grade of calcification (grade 1 (<0.3 cm), grade 2 (>0.3 cm, <1.5 cm), grade 3 (>1.5 cm; or ≥ 2 plaques >1.0 cm). Sample data sheet attached as appendix 2.
- Psychosexual changes in Peyronie's Disease Questionnaire (PDQ). [ Time Frame: 52 weeks ]The PDQ is highly responsive to treatment-related change in men with PD. It is self-administered, that measures psychosexual consequences after the presentation of PD. It is intended for men who have had vaginal intercourse in the past 3 months. The range of scores is from 0-24 points, with higher scores signifying greater psychosexual consequences from PD.
- Penile pain evaluation in Peyronie's Disease Questionnaire (PDQ). [ Time Frame: 52 weeks ]The PDQ is highly responsive to treatment-related change in men with PD. It measures penile pain in patients with PD. It is intended for men who have had vaginal intercourse in the past 3 months, which evaluate the levels of pain or discomfort based on last erection or vaginal intercourse. The range of scores is from 0-30 points, with higher scores signifying greater penile pain or discomfort.
- Goniometer measurement to determine degree of curvature of PD. [ Time Frame: 52 weeks ]Evaluate the total degree change of curvature improvement after treatment with Xiaflex measured by goniometer, an instrument that measures the angle of the curvature to determine the degree of the PD.
- International Index of Erectile Function (IIEF) Scores [ Time Frame: 52 weeks ]The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi- dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions, with a range of scores from 0-75, with lower scores signifying poorer erectile function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774264
|Contact: Manuel Molina, MDemail@example.com|
|Contact: Ranjith Ramasamy, MDfirstname.lastname@example.org|
|United States, Florida|
|Department of Urology, University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Madhumita Parmar 305-243-4873 email@example.com|
|Principal Investigator: Ranjith Ramasamy, MD|
|Principal Investigator:||Ranjith Ramasamy, MD||University of Miami|