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

NCT03862599 | Unknown DMC

• 1 other identifier: 250004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Keywords

erectile dysfunction; shockwave; treatment; prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Penile length

  12 months

• Urinary Incontinence

  12 months

• Adverse Events

  12 months

Study Arms (2)

Standard care + sham ESWT

SHAM COMPARATOR

Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT)

Device: Extra-corporeal shockwave therapy (ESWT); Other: Standard care

Standard care + active ESWT

ACTIVE COMPARATOR

Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT)

Device: Extra-corporeal shockwave therapy (ESWT); Other: Standard care

Interventions

Extra-corporeal shockwave therapy (ESWT) DEVICE

low-intensity extra-corporeal shockwave therapy

Standard care + active ESWT; Standard care + sham ESWT

Standard care OTHER

Cialis and vacuum pump

Standard care + active ESWT; Standard care + sham ESWT

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas' NHS Trust

London, United Kingdom

RECRUITING

Related 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.

  PMID: 29396020 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Tet Yap, FRCS (Urol)

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tet Yap, FRCS (Urol)

CONTACT

07748182772; tet.yap@gstt.nhs.uk

Findlay MacAskill, MRCS

CONTACT

07748182772; findlay.macaskill@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking of probe applicator at device manufacturer before ESWT use
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: March 5, 2019
• Study Start: June 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: May 1, 2025
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)