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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03862599
Other study ID # 250004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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