Clinical trial NCT04172558: Intracavernous Injection of Botox 100 U for Treatment of PDE5Is Inconvenient Patients With ED
Official title: Intracavernous Injection of Onabotulinumtoxin-A 100 U For Treatment of Phosphodiesterase Type 5 Inhibitors-Inconvenient Patients With Erectile Dysfunction: A Randamized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Erectile Dysfunction
Keywords: Botulimium Toxin
Eractile Dysfunction
ICI
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 124
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: International Index of Erectile Function (IIEF)
timeFrame: baseline, 2 weeks post treatment then every 3 months post treatment
measure: Dopller study
timeFrame: baseline, 2 weeks post treatment then every 3 months post treatment
measure: 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
timeFrame: baseline, 2 weeks post treatment then every 3 months post treatment
Secondary outcomes:
measure: Sexual Encounter Profile 2&3
timeFrame: baseline, 2 weeks post treatment then every 3 months post treatment
measure: Global Assessment Questionnaire
timeFrame: baseline, 2 weeks post treatment then every 3 months post treatment
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Banha University Hospitals
state: Kalubiaya
Study officials:
affiliation: Banha Univesity hosptals
name: Waleed El-Shaer, MD
role: PRINCIPAL_INVESTIGATOR
References: