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Penile Induration clinical trials

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NCT ID: NCT06303661 Recruiting - Peyronie Disease Clinical Trials

Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

The goal of this one arm clinical trial is to evaluate the safety and describe the clinical response of non-ablative radiofrequency treatment associated with shockwave therapy in men with Peyronie's disease. The main question[s] it aims to answer are: • is the treatment safe? • is there any clinical response to the proposed treatment? Participants will respond to five validated questionnaires: International Index of Erectile Dysfunction (IIEF-5), Medical Outcomes Study 36 - Item Short - Form Health Survey (SF-36), Peyronie's Disease Questionnaire (PDQ), Scale Hospital for Anxiety and Depression (SHAD) and the Erection Quality Questionnaire (EQQ); will undergo a physical assessment that includes palpation of the fibrotic plaque on the penis, pharmacological induction of erection, and assessment of the size of the fibrotic plaque through ultrasound. Every five sessions, the participant's degree of satisfaction will be measured using a 5-point Likert scale, as well as the evolution of symptoms will also be observed, using a 10-point Visual Analogue Scale (VAS) and penile pain, if present. The entire evaluation protocol will be applied before (pre-test), after treatment (post-test) and 1 month after the end of treatment. Volunteers will be monitored by telephone to verify the long-term response after 3, 6, 9 and 12 months of completed treatment in relation to the Likert scale and VAS. The treatments they'll be given are • of monopolar non-ablative radiofrequency associated with • low-intensity shock wave therapy.

NCT ID: NCT06065436 Recruiting - Clinical trials for Erectile Dysfunction

Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease

Start date: January 19, 2024
Phase: N/A
Study type: Interventional

The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.

NCT ID: NCT05777031 Recruiting - Clinical trials for Sexual Dysfunctions, Psychological

Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease

Start date: October 2, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.

NCT ID: NCT05768867 Recruiting - Peyronie Disease Clinical Trials

French Translation and Validation of the PEYronie's Disease QUESTionnaire

FRAPEYQUEST
Start date: March 6, 2023
Phase:
Study type: Observational

This study is a prospective cohort dedicated to peyronie's disease. The aim is to validate the french translation of the peyronie's disease questionnaire. The primary endpoint is the response rate to the questionnaire.

NCT ID: NCT05316714 Recruiting - Peyronie Disease Clinical Trials

Novel Nanofat Regenerative Surgical Technique for Peyronies' Disease Treatment

IPPNANOFAT
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Peyronies' disease (PD) is an acquired connective tissue disorder characterized with the growth of fibrous and/or calcified plaques in the tunica albuginea of the penis. The pathogenesis is still unclear, but the most accepted hypothesis is that in genetically prone individuals, trauma or repetitive microtraumas to the erect penis causes inflammation, and consequent growth of fibrous tissue due to degradation of the elastic fibers and fibrin deposition. The fibrous plaques in the tunica albuginea of the penis causes typical signs and symptoms: penile abnormal curvature, penile pain, erectile dysfunction, indentation, loss of girth, shortening of the penis, with significant distress experience and psychological bother. A lot of treatement have been proposed to date but with unsatisfactory results and the surgery results the definitive treatement but with possible risks. Autologous fat grafting was first described by Neuber in 1893 and since then it has developed over the next century. The initial goal of fat grafting was to treat volume losses created by disease or trauma. Further studies done by Zuk et al. in 2001 showed that lipoaspirate contains multipotent adipose stem cells (ADSCs) like in the bone marrow, thereby expanding opportunities in multiple fields. ADSCs have emerged as a key element of regenerative medicine surgery due to their ability to differentiate into a variety of different cell lineages. Moreover, their capacity of paracrine secretion of a broad selection of cytokines, chemokines, and growth factors make them highly clinically attractive. More specific, of particular interest are the anti-apoptotic, anti-inflammatory, proangiogenic, immunomodulatory, and anti-scarring effects that have been demonstrated for ADSCs, which effects on wound healing, soft-tissue restoration and scar remodelling. Nanofat firstly introduced by Tonnard in 2013, is an ultra-purified adipose tissue-derived product that is devoid of mature adipocytes but rich in ADSCs and with regenerative properties. The aim of the study is to investigate the use of nanofat grafting in the treatement of PD.

NCT ID: NCT05147779 Recruiting - Clinical trials for Erectile Dysfunction

Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Peyronie's Disease, ED, and Interstitial Cystitis

Start date: September 12, 2021
Phase: Phase 1
Study type: Interventional

This trial will study the safety and efficacy of intravenous and intracavernosal or interstitial delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Peyronie's disease, erectile dysfunction , and Interstitial Cystitis

NCT ID: NCT05108558 Recruiting - Peyronie's Disease Clinical Trials

Efficacy of a Novel CCH Protocol for PD Among Prior Non-responders

Start date: September 20, 2021
Phase: Phase 4
Study type: Interventional

Compare key clinical outcomes between controls and men treated with a novel CCH administration protocol among men previously unresponsive to CCH administration.

NCT ID: NCT04821115 Recruiting - Peyronie Disease Clinical Trials

Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease

ONDELA
Start date: April 6, 2021
Phase: N/A
Study type: Interventional

Investigation of the effect of Low-intensity extracorporeal shockwave therapy (ESWT) for Peyronie's disease (PD) via a single blind, sham-controlled, randomized clinical trial. Investigators will not be blinded to group assignments, but penile curvature will be assessed from coded patient pictures by a blinded assessor.

NCT ID: NCT04512287 Recruiting - Clinical trials for Sexual Dysfunction, Physiological

PRP for Treatment of Peyronie's Disease

Start date: March 29, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD).

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.