Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction
NCT ID: NCT06583590
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
32 participants
INTERVENTIONAL
2024-08-01
2025-12-01
Brief Summary
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Detailed Description
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All patients will be subjected to the following:
* History taking.
* Clinical examination (general and local genital examination).
* International Index of Erectile Function (IIEF-5) before and after treatment (Rosen et al., 2002).
* Erection Hardness Score (EHS) before and after treatment (Mulhall et al., 2006).
* Global assessment questionnaire after treatment (Giuliano et al., 2007).
* All patients will be examined by Duplex Doppler ultrasonography in the basal condition and after the induction of penile erection with the assistance of an intracavernous injection of alprostadil 20 μg/mL.
* All patients will receive single dose of ICI of 100u of (BTXA) combined with 5mg oral Tadalafil once daily for 3 months.
* The subjects will be re-examined and International Index of Erectile Function (IIEF-5), Erection Hardness Score (EHS)and penile color Doppler ultrasound with PGE-1 injection will be done at 6 and 12 weeks from the start of therapy in addition to Global assessment questionnaire will be done at 12 weeks from the start of therapy
\* Procedure
* The patients will lied down in supine position. After cleansing the skin with alcohol, intracavernosal injection of single dose 100U (BTX-A) diluted in isotonic saline 2cm proximal to coronal margin at right and left sides will be performed and the injection site will be pressed directly for two minutes. To prevent systemic toxicity, a veno-occlusive ring will be used at the base of the penis at the time of injection and will be kept in place for 15 minutes after injection.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group 1
32 patients will be injected single intracavernosal injection of 100 unit of Botulinum toxin A accompained by oral daily tadalafil 5 mg for 3 months.
Botulinum toxin A
Botulinum 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
Tadalafil 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.
Interventions
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Botulinum toxin A
Botulinum 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
Tadalafil 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
21 Years
MALE
No
Sponsors
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Aswan University
OTHER
Cairo University
OTHER
Aswan University Hospital
OTHER
Responsible Party
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El Hassan Mohsen Mansour Mahmoud
Assistant lecturer
Locations
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Aswan University-Faculty of Medicine
Aswān, Aswan Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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943/7/24
Identifier Type: -
Identifier Source: org_study_id