Intracavernous Injection of Botox 100 U for Treatment of PDE5Is Inconvenient Patients With ED

Study Overview
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Brief Summary
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There is a new emerging concept that Botulinum Toxin Type A may have a potential role in treatment of erectile dysfunction with a longer duration of action. So, the investigators opted to perform this study to compare ICI of Botulinum Toxin Type A versus Trimix for treatment of ED.

Detailed Description
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Background: Direct Intracavernosal injections of vasoactive agents to treat erectile dysfunction were first described in 1982 using papaverine. Later on many agents have been introduced for ICI. one of most newly introduced ICI agents for treatment of ED is Botulinum Toxin Type A. Purpose: The aim of this study will to compare the safety, efficacy, tolerability and adverse events s of ICI of BTX-A 100 unit in comparison with ICI Trimix in the treatment of Erectile Dysfunction for PDE5Is non-responders. Design, Settings, and Participants: This study will be conducted on 124 patients at minimum, complain of erectile dysfunction not responding to different PDE5Is therapy presenting to Urology department and outpatient clinic at Banha University Hospital. patients will be randomized into 2 equal groups: The treatment group A: will receive a single ICI of BTX-A 100 units . The treatment group B: will receive on-demand ICI of Trimix . Assessment for all groups will be done by Sexual Health Inventory for men (SHIM), Sexual Encounter Profile questions 2 and 3 (SEP 2 & SEP 3), and the global assessment question (GAQ) based on pre-treatment, 2 weeks, 3 months and every 3 months after treatment.

Official Title
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Intracavernous Injection of Onabotulinumtoxin-A 100 U For Treatment of Phosphodiesterase Type 5 Inhibitors-Inconvenient Patients With Erectile Dysfunction: A Randamized Controlled Trial.

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Biological: OnabotulinumtoxinA
* Drug: Trimix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 40 years with ED not responding to PDE5Is, non compliant or contraindicated to PDE5Is. A No response on Sexual encounter profile questions (SEP 2 & 3) Exclusion Criteria: psychiatric condition Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BTX100 group<br>ICI of Botox 100 U | Biological: OnabotulinumtoxinA<br>* a single ICI of BTX-A 100 units one day after the penile Doppler/trimix test.<br>* Other names: Grroup 1;|
| Active Comparator: Trimix group<br>ICI of Trimix | Drug: Trimix<br>* on demand ICI of Trimix<br>* Other names: Group 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function (IIEF) | Changes in the Erectile Function (EF) domain score of the International Index of change of Erectile Function measured by (IIEF) between treatment periods and baseline in the 2 study arms. It ranges between 0 to 25 | baseline, 2 weeks post treatment then every 3 months post treatment | 
| Dopller study | measurement of Cavernosal artery peak systolic and end diastolic velocities before and after ICI | baseline, 2 weeks post treatment then every 3 months post treatment | 
| Erection hardness score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Clinical assessment of the Erection hardness score by the investigators in both Erection hardness score | Erection hardness score which is ranged 0 to 4 | baseline, 2 weeks post treatment then every 3 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Encounter Profile 2&3 | Assessment of SEP before and after ICI. patient answer ' Yes' or 'No'. | baseline, 2 weeks post treatment then every 3 months post treatment | 
| Global Assessment Questionnaire | Global Assessment Questionnaire with Yes/No response | baseline, 2 weeks post treatment then every 3 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eractile Dysfunction, ICI, Botulimium Toxin