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

Not Applicable

Recruiting

• Conditions: Erectile Dysfunction Following Radical Prostatectomy
• Interventions: Device: Extra-corporeal shockwave therapy (ESWT); Other: Standard care

• Registration Number: NCT03862599
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2019-03-02
• Study First Posted: 2019-03-05
• Study Start: 2021-06-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07
• Primary Completion: 2024-10-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care + sham ESWT	Standard care	Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT)
Standard care + active ESWT	Standard care	Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT)
Standard care + sham ESWT	Extra-corporeal shockwave therapy (ESWT)	Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT)
Standard care + active ESWT	Extra-corporeal shockwave therapy (ESWT)	Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT)

Primary Outcome Measures

Name	Time	Method
Sexual Function	6 months	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

Secondary Outcome Measures

Name	Time	Method
Urinary Incontinence	12 months	Measurement of average change in EPIC questionnaire from baseline (pre-RP) to 24 week-FU and time points to 12 months
Adverse Events	12 months	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Penile length	12 months	Clinical measurement of change in stretched flaccid penile length from baseline and time points to 12 months

Trial Locations

Locations (1)

Guy's and St Thomas' NHS Trust; 🇬🇧 London, United Kingdom