NCT03192917

Brief Summary

The purpose of this project is to verify the relationship between low intensity shock wave treatment (LI-SWT) and increased scores in self-assessment regarding to erectile function (ED) and sexual intercourse, in patients, who has undergone a radical prostatectomy (RP). The data will be obtained from patients using international accepted sexual questionnaires prior to the LI-SWT and 5, 12 and 24 weeks following treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

May 29, 2017

Last Update Submit

December 29, 2019

Conditions

Erectile DysfunctionPost-Op ComplicationProstatic Diseases

Keywords

Shock wave therapyerectile dysfunction

Outcome Measures

Primary Outcomes (4)

  • Erection hardness score (EHS) Baseline

    A five entity questionnaire to review the self-esteem of erection during sexual intercourse. The questionnaire will be mailed to the participants home adresses together with a return envelope.

    2 weeks prior first treatment

  • Erection hardness score first follow up

    A five entity questionnaire to review the self-esteem of erection during sexual intercourse. The questionnaire will be mailed to the participants home adresses together with a return envelope.

    5 weeks after last treatment

  • Erection hardness score second follow up

    A five entity questionnaire to review the self-esteem of erection during sexual intercourse. The questionnaire will be mailed to the participants home adresses together with a return envelope.

    12 weeks after last treatment

  • Erection hardness score third follow up

    A five entity questionnaire to review the self-esteem of erection during sexual intercourse. The questionnaire will be mailed to the participants home adresses together with a return envelope.

    24 weeks after last treatment.

Secondary Outcomes (4)

  • The International index of erection function (IIEF-5) baseline

    2 weeks prior first treatment

  • The International index of erection function (IIEF-5) first follow up

    5 weeks after last treatment

  • The International index of erection function (IIEF-5) second follow up

    12 weeks after last treatment

  • The International index of erection function (IIEF-5) third follow up

    24 weeks after last treatment

Other Outcomes (7)

  • Danish Prostate Symptoms Scoring scheme (DAN-PSS)

    2 weeks prior first treatment

  • Danish Prostate Symptoms Scoring scheme (DAN-PSS)

    24 weeks after last treatment

  • Pain sensation

    first treatment

  • +4 more other outcomes

Study Arms (2)

Active treatment

EXPERIMENTAL

This group of participant will receive low intensity shock wave treatment accounted on their penile shaft once every week for 5 weeks.

Procedure: Low intensity extracorporeal shock wave treatment (LI-ESWT)

Placebo group

PLACEBO COMPARATOR

this group of participant will meet up for treatment. The treatment given will be the exact same as the active group, but the transducer used for shock wave treat will me capped, meaning that no shock waves are transmitted to their penis.

Procedure: Low intensity extracorporeal shock wave treatment (LI-ESWT) sham

Interventions

Low intensity extracorporeal shock wave treatment (LI-ESWT)PROCEDURE

Shock wave treatment with 3000 Hz for 10 min on the penile shaft. This will be done one time a week for five weeks.

Also known as: Storz Medical AG, DUOLITH® SD1
Active treatment
Low intensity extracorporeal shock wave treatment (LI-ESWT) shamPROCEDURE

A specialized cap can be applied to the chock wave device, which disallow shock waves to transmit through the unit.

Also known as: DUOLITH® SD1 with cap
Placebo group

Eligibility Criteria

Age18 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly men undergone a surgery for prostatectomy will be included in this trial.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Erectile dysfunction for more than 6 months,
  • Time since prostatectomy must be at least 9 month
  • At least unilateral nerve-sparing RP.
  • Erection Hardness Score (EHS) less than 2 and an Index of Erectile Function (IIEF-5) score less than 17
  • Age 20-80 years
  • have been in a relationship for more than 3 months.
  • Participant can give informed consent.

You may not qualify if:

  • Men with ED due to other reason than RD (psychogenic, neurological pathology or organic ED etc.)
  • Rectal extirpation, radiation therapy to the pelvic area and recovery from any other cancer within the past 5 years are excluded.
  • Participants with heart disease prohibiting sexual activity or taking medication with antiandrogens, anticoagulant (apart from aspirin) or systemic use of glucocorticoids within 5 weeks.
  • ED treatment within the last 7 days (screening phase), oral medication, vacuum devices, injections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital (OUH)

Odense, Fyn, 5230, Denmark

Location

MeSH Terms

Conditions

Erectile DysfunctionPostoperative ComplicationsProstatic Diseases

Interventions

salicylhydroxamic acidCapsules

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Lars Lund, MD professor

    Department of Urology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 20, 2017

Study Start

November 1, 2017

Primary Completion

August 1, 2018

Study Completion

September 1, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)