Low Intensity Extracorporeal Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy

Status: Unknown
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Erectile dysfunction (ED) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. A few small studies have recently shown that low-intensity shockwave therapy may improve sexual performance in men with ED. However, the optimal dosage and length of treatment is yet to be determined. The investigators propose a randomised trial evaluating the efficacy and safety of low-intensity shockwave therapy in men with ED following prostatectomy surgery.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 65
Healthy Volunteers: f
View:

• Age 40 - 65

• Diagnosed with low/intermediate-risk prostate cancer:

• PSA \< 20 ng/ml

• Gleason score \< 8

• PCa stage =\< T2b

• Baseline IIEF-ED 17-30 without erectogenic aids

• No pre-operative urinary incontinence (no usage of urinary pads)

• Sexually active

• Able to understand and complete patient questionnaires

• Consent to participate

Locations
Other Locations
United Kingdom
Guy's and St Thomas' NHS Trust
RECRUITING
London
Contact Information
Primary
Tet Yap, FRCS (Urol)
tet.yap@gstt.nhs.uk
07748182772
Backup
Findlay MacAskill, MRCS
findlay.macaskill@gstt.nhs.uk
07748182772
Time Frame
Start Date: 2021-06-01
Completion Date: 2025-05-01
Participants
Target number of participants: 100
Treatments
Sham_comparator: Standard care + sham ESWT
Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT)
Active_comparator: Standard care + active ESWT
Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT)
Sponsors
Leads: Guy's and St Thomas' NHS Foundation Trust

This content was sourced from clinicaltrials.gov