A Phase 2/3 interventional study of Botulinum toxin A and Tadalafil 5mg in Erectile Dysfunction With Diabetes Mellitus, sponsored by Aswan University Hospital. Recruiting at 1 site in Egypt. Open to male participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Aswan University Hospital · Phase 2/3, Interventional, and Treatment
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.
Total of (32) male patients will be included in this study and will be recruited from the Andrology, Sexology \& STDs outpatient clinics- Faculty of medicine -Cairo and Aswan Universities. All those patients are complaining of erectile dysfunction Unresponsive to Approved Pharmacological Treatments. Each patient will have an informed consent obtained prior to conducting the study.
All patients will be subjected to the following:
Global assessment questionnaire after treatment (Giuliano et al., 2007).
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
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 32 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Aswan University Hospital is the lead sponsor of 97 studies on the registry; 3 are open to participants now.
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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.
Drug: Botulinum toxin A · Drug: Tadalafil 5mg
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.
Also known as: Botox, BTX-A
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.
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 months
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: 3months
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
Time frame: starting 6-12 months after publication
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Aug 2025, 12 months after the start.
Of 23 phase 2/3 interventional studies under Diabetes Mellitus, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 56. This study's planned 12 months is below that.
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Studies of the drugs tested here: Botulinum toxin type A · Tadalafil
Aswan University Hospital