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Penile Induration clinical trials

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NCT ID: NCT03774264 Completed - Peyronie Disease Clinical Trials

Treatment Response to Xiaflex for Men With Peyronie's Disease

Start date: September 2, 2018
Phase:
Study type: Observational

The purpose of this research study is to develop a database of patients with Peyronie's disease who are treated at the University of Miami. The collected data will help the researchers to better understand Peyronie's disease and its response to therapy.

NCT ID: NCT03767452 Recruiting - Peyronie's Disease Clinical Trials

Additional Xiaflex® Treatment in Patients With Peyronie's Disease Recurrence, Worsening, or Incomplete Response

Start date: October 4, 2018
Phase: Phase 4
Study type: Interventional

Subjects who have had an incomplete response to previous Xiaflex® will receive up to 4 additional cycles of treatment.

NCT ID: NCT03530540 Recruiting - Peyronie Disease Clinical Trials

Low-Intensity Extracorporeal Shockwave Therapy and Vacuum Erectile Device as a Treatment for Peyronies Disease.

Start date: March 13, 2018
Phase: N/A
Study type: Interventional

Aim The primary aim is to examine whether LI-ESWT and vacuum erectile device (VED) followed by manipulation exercises has beneficial effect on PD patients compared to a placebo group. Primary Outcome - Peyronie's Disease Questionnaire (PDQ) - Visual Analogue Scale score (VAS) - International Index of Erectile Function 5 (IEFF-5) - Penile curve measurements (gold standard) on pictures before and after treatment - Plaque size Method This study is designed as a prospective, randomized, double-blinded, placebo-controlled with follow-up after 1, 3 and 6 months. A total of 50 participants who meets the inclusion criteria's will randomly be assigned to I(intervention) or C(control) group based on a randomization list which is retained in a sealed envelope. The content of the envelope is only familiar to the Head of the Department of Urology to ensure valid randomization. All treatment sessions are executed at the outpatient clinic of the department of urology department L at Odense University Hospital(OUH). All patients receive treatment with the same device a Duolith® SD1 T-Top from Storz Medical. However, when treating patients in the control group the handpiece will be covered by a shockwave absorbent material. Settings and setup are identical in both groups to make sure that patients are unable to acknowledge which treatment is being performed.

NCT ID: NCT02414308 Recruiting - Clinical trials for Erectile Dysfunction

Management of Peyronie's Disease With Adipose Tissue Stem Cell

Start date: June 2013
Phase: N/A
Study type: Interventional

Erectile dysfunction is growing in prevalence all over the world and one of the most existing disease in old age patients There is many lines of treatment concerning the status of patient like psychosexual, medical, and surgical treatment But Pyronie's disease is common now among people especially diabetics, and the role of treatment still controversial in results We can start conservative treatment and then surgical treatment if fail but the outcome still not convinced Many patients refuse to fix penile prosthesis and to make operation like nesbite for probability of shortening of penis We start to use stem cell in patients have erectile dysfunction and Peyronie's disease The injection of stem cell will be at corpora cavernosa and intra dorsal penile artery under Doppler device guidance

NCT ID: NCT02395029 Completed - Peyronie's Disease Clinical Trials

Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of PD

PMD-MSC-PD-01
Start date: August 2013
Phase: Phase 1
Study type: Interventional

Prospective, open labeled, non-randomized, study to be conducted at a single center. Ten subjects will undergo an injection of Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs) into the penis for the treatment of Peyronie's Disease. Follow up visits will be conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be eligible for re-injection at 3 months and/or 6 months as determined by the clinician based on patient reported treatment satisfaction.

NCT ID: NCT02298829 Completed - Peyronie's Disease Clinical Trials

Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease

Start date: November 2014
Phase:
Study type: Observational

This a Phase 4 non-treatment, long-term follow-up study of subjects who received AA4500 in a 12-month double blind placebo-controlled study (AUX CC 803 or AUX-CC-804) or in a 9-month open label study (AUX-CC-802 or AUX-CC-806) sponsored by Auxilium Pharmaceuticals, Inc. After participation in one of the aforementioned studies, subjects will be followed yearly for up to 4 consecutive long-term follow-up visits with at least 6 months between consecutive visits

NCT ID: NCT02267460 Completed - Peyronie's Disease Clinical Trials

An Open-label Study to Assess the Safety and Effectiveness of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Treating Men With Peyronie's Disease

Start date: October 2014
Phase: Phase 3
Study type: Interventional

Enrollment will include approximately 30 AA4500 naïve subjects. Subjects will be divided by degree of penile curvature and then randomized in a 1:1 ratio to one of the following treatment groups: - AA4500 with investigator modeling - AA4500 without investigator modeling Each subject will receive 2 injections of AA4500, separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles. Approximately 14 days after the second injection of AA4500, each subject will visit the study site and the investigator will assess the subject and instruct the subject on appropriate use of the ErecAid® Esteem® Manual Vacuum Therapy System.

NCT ID: NCT02072018 Completed - Peyronie's Disease Clinical Trials

Peyronie's Disease Treatment Protocol

Start date: June 2013
Phase: Phase 1
Study type: Interventional

Treatment of Peyronie's disease remains difficult. The purpose of this study is to test the safety and efficacy of a new compound to treat this disease.

NCT ID: NCT01685437 Completed - Peyronie's Disease Clinical Trials

A Phase 3, Open-label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease

Start date: September 2012
Phase: Phase 3
Study type: Interventional

This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. Enrollment will include all subjects who meet the eligibility criteria and who received placebo and completed one of the Auxilium-sponsored studies AUX-CC-803 or AUX-CC-804.

NCT ID: NCT01578473 Completed - Peyronie's Disease Clinical Trials

Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease

PD+
Start date: May 23, 2013
Phase: Phase 1
Study type: Interventional

Two recent studies have identified low levels of serum testosterone in association with Peyronie's Disease (PD), with a significant correlation noted between severity of testosterone deficiency and severity of curvature. The study hypothesis is to determine whether treatment with testosterone may help men with PD and penile curvature.