Erectile Dysfunction (ED) post radical prostatectomy Urological and Genital Diseases
Conditions
Interventions
The study will require the subject to attend a Screening Visit within 4 weeks prior to the subjects scheduled radical Prostatectomy. The subject will then attend Visit 1 (Study Drug Administration Vis
Sponsors
RestoriT Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent. 2. Adult (18 years or older), male subjects with diagnosis of prostate cancer and scheduled radical prostatectomy either nerve sparing and non-nerve sparing. 3. In generally good health in the opinion of the Investigator. 4. Willing and able to comply with all study procedures in the opinion of the Investigator.
Exclusion criteria
Exclusion criteria: 1. History of a significant medical condition that would preclude further study participation, in the opinion of the Investigator. 2. Symptoms suggestive of COVID-19 infection and positive PCR test. 3. Undergone radiotherapy post radical prostatectomy. 4. Received chemotherapy post radical prostatectomy. 5. Experiencing significant incontinence post operatively. 6. Use of PDEV inhibitors within 1 month prior to the screening visit. 7. History of allergy to aviptadil or phentolamine mesilate or any of the other ingredients of the study medicine Invicorp. 8. Current diagnosis or history of leukaemia (cancer of the blood), multiple myeloma (bone cancer) or sickle cell anaemia or trait (a blood disease). 9. Currently taking anticoagulant agents such as warfarin or heparin, (except low molecular weight heparin given subcutaneously for venous thromboembolism prophylaxis), including oral blood thinning medicines such as dabigatran, rivaroxaban, apixaban within 1 month prior to the screening visit. 10. Anatomical deformation of the penis, such as angulation, history of Peyronie’s disease or abnormal fibrous tissue in the erectile tissue of the penis (cavernosal fibrosis). 11. Subject has penile implant. 12. Men for whom sexual activity is not advisable or is contraindicated due to organic disease. 13. Positive for hepatitis B, hepatitis C, or HIV infection. 14. Safety testing abnormalities at the Screening Visit, that are indicative of a medical condition and that would preclude further participation, in the opinion of the Investigator. 15. Subject unwilling to perform study drug home administration. 16. History of alcohol or drug abuse within 1 year prior to the Screening Visit. 17. Use of an investigational (non-registered) drug within 30 days before the first Screening Visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sexual function questionnaire (International Index of Erectile Function [IIEF-15]) collected pre-dose at the Screening Visit, Visit 1, 2, 3 and 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Penile rigidity and tumescence measured using the Rigiscan Plus Monitor at Visit 1 approximately 15 minutes post Invicorp administration. They will also be performed at Visits 2, 3 and 4, approximately 15 minutes post study drug administration. Rigiscans should be performed as per the Rigiscan User Manual. 2. Sexual function questionnaires pre- and post-surgery 2.1. Erection hardness score (EHS); 2.2. SEAR (self-esteem and relationship) questionnaire; 2.3. SEP (sexual encounter profile) question 2 and 3 only. 3. Safety and tolerability of Invicorp measured using adverse events and Subject Diary cards throughout the study | — |
Countries
England, United Kingdom
Outcome results
None listed