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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623001007628

Enrollment

124

Registered

2023-09-15

Start date

2023-11-06

Completion date

2024-11-06

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is evaluating the utility of an intracavernosal injection of botox for penile rehabilitation in men undergoing a nerve sparing radical prostatectomy, a procedure which causes erectile dysfunction in over two-thirds of patients. Who is it for? You may be eligible for this study if you are an adult male aged 40 to 75 years old who has been diagnosed with prostate cancer, and is undergoing unilateral/bilateral nerve sparing radical prostatectomy. Study details Participants will be randomly assigned to receive an intracavernosal injection of either botox or normal saline immediately at the end of their surgical procedure (radical prostatectomy). Participants will also be asked to complete questionnaires regarding their sexual function and quality of life at several timepoints during the 12 months following the prostatectomy. It is hoped that findings from this study will help determine the utility of botox in penile rehabilitation for men with prostate cancer undergoing radical prostatectomy.

Interventions

100 u Botulinum toxin type A administered as a once only dose following radical prostatectomy surgery (Randomised 1:1 to placebo) Mode of administration - Intracavernosal injection Administered by a urologist Administered at the end of the procedure in theatre A record of the administration will be made in the patients medical records

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

40 Years to 75 Years

Healthy volunteers

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

Outcome results