Health TrialsbyHealthPanel

PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)

ConditionErectile Dysfunction Following Radical Prostatectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-70
SponsorThe Netherlands Cancer Institute

About this trial

The PEHAB-II study is prospective, randomized trial designed to assess the effect of two different rehabilitation strategies on the recovery of erectile function in nerve sparing prostatectomy patients. The two rehabilitation strategies consist of 1)12 months daily doses of 100 mg Sildenafil combined with vacuum device (VED) therapy for 10 minutes a day, five times a week or 2) Standard of care: monotherapy with an on-demand dosage of 100mg Sildenafil. The study will be performed in multiple centers in the Netherlands.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years and < 70 years

Patients who have a penis that has developed naturally, without surgical interventions.

Histologically confirmed PCa

Scheduled for RP as primary treatment with the intention of at least a one-sided nerve-sparing procedure.

Disqualifiers

Previous pelvic radiation therapy

Patients on Androgen Deprivation Therapy (ADT)

Patients with diseases that affect the red blood cells (e.g., sickle cell anaemia), blood cancer (leukaemia) or bone marrow tumors Regarding history of cardiovascular diseases

Patients with heart failure New York Heart Association (NYHA) ≥ class 3

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sildenafil

    Drug

    Taken daily or on demand. First two weeks dosage of 75mg to manage side effects. If side effects are bearable, dosage will be adjusted to 100mg

  • Erectile vacuum device

    Device

    5 days a week, generating 5 erections per day

Treatment groups

198 Participants
are divided into 2 treatment groups
Group A: Intensive rehabilitation armExperimental treatment 2 interventions
Group B: Less intensive rehabilitation armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Erectile function without tools

To determine the difference in rates of patients achieving good unassisted erections at 24 months of follow-up after receiving either 12 months of 75/100mg Sildenafil daily and VED therapy 5 times a week or 75/100mg Sildenafil on demand (≤3 times a week) as a penile rehabilitation program.

Time frame
24 months

Secondary outcomes

1

Erectile Function

To evaluate time to- and percentage of patients in both arms in regaining unassisted and assisted erectile function sufficient for intercourse during follow-up in each rehabilitation arm. As well to assess and compare stretched penile length at 12 months compared to baseline.

Time frame
Varying from 6-24 months
2

Health en sexual quality of life:

To compare sexual function scores (i.e. orgasmic function), climacturia, feelings of masculinity, health-related quality of life, partner-interaction, between the treatment groups and between hetero versus gay/bisexual patients during follow-up.

Time frame
12 and 24 months
3

Adherence

To evaluate differences between the groups regarding adherence to the penile rehabilitation program

Time frame
12 months
4

Best tool to evaluate erectile function:

To evaluate differences in pre-operative IIEF-EF and EPIC-sexual domain scores between patients who are engaged in sexual intercourse and those that are not.

Time frame
6 months

Other outcomes

Sponsors and contacts

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The Netherlands Cancer Institute

Lead sponsor

Antoni van Leeuwenhoek Hospital

Collaborator

Viatris Inc.

Collaborator

Memidis Pharma

Collaborator

Source ClinicalTrials.gov
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