Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age21+
SponsorAswan University Hospital
About this trial
Study is aiming to evaluate safety, efficacy and durability of intracavernosal injection (ICI) of Botulinum toxin A plus oral tadalafil in controlled diabetic men with refractory Erectile Dysfunction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult controlled diabetic married men who proved to be vasculogenic ED by Penile Duplex.
Men who had shown an insufficient response for at least 3 months to the registered PDE5-Is at the highest approved dose, either on-demand or daily, or to PGE1 ICIs.
Severe erectile dysfunction (erection hardness score ≤ E3 after intracavernosal injection of PGE-1).
Disqualifiers
Men who had cardiovascular disease interfering with sexual activity.
Men with history of an unstable psychiatric conditions
Presence of penile anatomical abnormalities that would significantly impair erectile function.
History of spinal or pelvic radical surgery.
Trial design
Design model
Single group
Treatments tested in this trial
Botulinum toxin A
DrugBotulinum toxin (BoNT) is One of the most potent toxins known to humans produced by Clostridium botulinum that has been used to treat several striated and smooth muscle disorders. Because the pathophysiology and the reason for patients' lack of response to PDE5I is insufficient smooth muscle relaxation and veno-occlusive disorder (VOD) , BTX-A may prove to be a viable treatment for this patient population due to its availability to facilitate long-acting cavernosal smooth muscle relaxation by inhibition of the release of noradrenaline from the adrenergic neurons acting on the cavernosal smooth muscle. Thus, the dominant sympathetic basal tone of the cavernosal smooth muscle is essentially removed, facilitating the occurrence of an erection.
Tadalafil 5mg
DrugTadalafil is one of 5-phosphodiesterase inhibitors that used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection.Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Group 1Other 2 interventions
Trial outcomes
Primary outcomes
1
Treatment.
The primary outcome is to assess the effect of single intra-cavernosal injection of 100 unit of botulinum-A toxin plus daily intake of 5mg oral tadalafil in 32 adult diabetic patients with erectile dysfunction to detect its effect on on the erectile function status by reporting changes in IIEF and penile doppler parameters.
Time frame
3 monthsSecondary outcomes
1
Secondary adverse events of the drug.
The second outcome is to assess the safety of the drug injection by reporting any secondary adverse events during or after injection such as mild pain, discomfort, edema, hematoma formation or chance of infection or psychological effects.
Time frame
3monthsSponsors and contacts
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Source ClinicalTrials.gov