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

Erectile Dysfunction Following Radical Prostatectomy Clinical Trial

— LiST-PRP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03862599
• Other study ID #: 250004
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: March 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Tet Yap, FRCS (Urol)
• Phone: 07748182772
• Email: tet.yap[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Erectile dysfunction (ED) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. At present, this debilitating consequence of surgery is managed in a step-wise approach including oral medication, injections and in severe cases, insertion of a penile prosthesis. A few small studies have 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. Low-intensity shockwave therapy would be a non-invasive treatment to preserve and improve patient's sexual function.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Anatomical abnormalities in the genitalia or pelvic region
• Post-RP complications that could impact safety or effectiveness of ESWT (eg. hematoma, fistula, unresolved anastomotic leak)
• Incomplete tumor removal (positive surgical margin)
• Tumor upstaging beyond T2b
• Nerve sparing score > 5
• Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
• Untreated hypogonadism (serum total testosterone < 300 mg/dL)
• Anti-coagulant medication, except acetylsalicyclic acid up to 100mg daily
• Any other condition that would prevent the patient from completing the study, as judged by the principle investigator

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy

Intervention

Device:
• Extra-corporeal shockwave therapy (ESWT)
low-intensity extra-corporeal shockwave therapy

Other:
• Standard care
Cialis and vacuum pump

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. J Sex Med. 2018 Mar;15(3):334-345. doi: 10.1016/j.jsxm.2018.01.003. Epub 2018 Feb 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Function	Measurement of average change in IIEF-ED from baseline (pre-RP) to 24 week-FU 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction 5 being the worst outcome	6 months
Secondary	Penile length	Clinical measurement of change in stretched flaccid penile length from baseline and time points to 12 months	12 months
Secondary	Urinary Incontinence	Measurement of average change in EPIC questionnaire from baseline (pre-RP) to 24 week-FU and time points to 12 months	12 months
Secondary	Adverse Events	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	12 months