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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Erectile Dysfunction Following Radical Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Masking of probe applicator at device manufacturer before ESWT use

Study Groups

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Standard care + sham ESWT

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

Group Type SHAM_COMPARATOR

Extra-corporeal shockwave therapy (ESWT)

Intervention Type DEVICE

low-intensity extra-corporeal shockwave therapy

Standard care

Intervention Type OTHER

Cialis and vacuum pump

Standard care + active ESWT

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

Group Type ACTIVE_COMPARATOR

Extra-corporeal shockwave therapy (ESWT)

Intervention Type DEVICE

low-intensity extra-corporeal shockwave therapy

Standard care

Intervention Type OTHER

Cialis and vacuum pump

Interventions

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Extra-corporeal shockwave therapy (ESWT)

low-intensity extra-corporeal shockwave therapy

Intervention Type DEVICE

Standard care

Cialis and vacuum pump

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No