Assessing the utility of Intra-cavernous injection of Botulinum neurotoxin for recovery of erectile function after radical prostatectomy: Randomized controlled trial

Phase 2

• Conditions: Erectile Dysfunction; Prostate Cancer; Renal and Urogenital - Other renal and urogenital disorders; Cancer - Prostate

• Registration Number: ACTRN12623001007628
• Lead Sponsor: A/Prof Homayoun Zargar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-15
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 124

Inclusion Criteria

•Patients aged between 40-75 years inclusive with a Sexual Health Inventory for Men (SHIM) score of > 21 at baseline who are planned to undergo radical prostatectomy for prostate cancer.
•Patients with plan for unilateral/bilateral nerve sparing surgery
•English speaking

Exclusion Criteria

Men with locally advanced disease not suitable for nerve sparing surgery
Men on androgen suppressive treatment
Non-English speaking
Patients who have a history of radiotherapy to any of the pelvic organs
Patients who had prior focal therapy for prostate cancer
Patients who have a history of neuromuscular disorders
Men with pre-existing erectile dysfunction defined as a Sexual Health Inventory for Men (SHIM) score of 21 or less

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sexual Health Inventory for Men (SHIM) score at 6 months post-surgery<br>This tools is validated to assess the severity of Erectile dysfunction and is a questionnaire which will be adminstered by medical practitioner or a nurse[ 6 months post surgery (Radical Prostatectomy)]