Clinical trial NCT02042651: A Sham Controlled Study of the Effects of Ultrasonic Shockwaves as a Treatment for Chronic Pelvic Pain
Official title: Low Intensity Extracorporeal Shockwave Therapy Against Chronic Pelvic Pain: a Randomized and Sham Controled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Pelvic Pain
Keywords: ESWT
Chronic pelvic pain
randomized
sham controlled
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction:

Chronic pelvic pain with unknown pathology is a condition that affects both men and women. the condition is defined as pelvic pain lasting for a minimum of 6 months without any known etiology eg. cancer, infection or inherent anatomical abnormalities. Low intensity extracorporeal shockwave therapy (LIESWT) enables the practitioner to deliver a small amount of energy approximately 5 cm under the skin of the patient without damaging the skin. This have been shown to increase blood flow and accelerate healing which could also be beneficial in chronic pelvic pain patients.The purpose of this study is to investigate the effects of LIESWT on chronic pelvic pain.

Methods:

All patients will be treated at the Birthe Bonde clinic, in Copenhagen, Denmark.

The investigators anticipate to include 100 chronic pelvic pain patients in the study.

included patients will be randomized into two groups: active treatment or sham treatment.

All patients will be required to provide a urine sample and a semen sample prior to final inclusion. Samples will be analyzed for microbial growth. Furthermore, patients will undergo a digital rectal exploration and finally all patients is required to provide an informed consent in order to be included in the study.

A Storz Doulith SD1 T-Top (CE1275) will be used to generate shockwaves. Patients will receive the treatment once a week until their symptoms have seized or for a maximum of 6 times. Each treatment consists of 3000 shockwaves applied to the perineum with a energy density of 0.25-0.40 millijoule(mJ)/mm2 and a frequency of 3 hz.

Participants will fill out a questionnaire one week before the treatment, one week, four weeks, and twelve weeks after the last treatment.

Possible gains from this study:

The investigators hope to provide further evidence for this treatment and consequently be able to offer the treatment as an alternative to the very limited array of treatments existing for this group of patients today.

Ethics, funding, and publication:

The study is performed in compliance with the Helsinki declaration. External funding have been applied for but not yet received. Participants will be informed of sources of external funding. The result of the study will be published as soon as possible, preferably in a peer-reviewed international journal.


Eligibility criteria: Inclusion Criteria:

* pelvic pain with a duration of more than 6 months
* be able to read and understand the study information

Exclusion Criteria:

* known etiology for pelvic pain eg. cancer, infection, inherent abnormalities.
* diagnosed with hemophilia
* receiving anti thrombotic therapy other than hearth magnyl
* diagnosed with thrombocytosis
* active cancer
* treated with IV glucocorticoids within the last 6 months
* disease in the rectal area
* abnormal digital rectal exploration
* bacteriospermia

Primary outcomes:
measure: Change in NIH-Chronic Prostatitis Symptom Index
timeFrame: Change from baseline to twelve weeks after final treatment
Secondary outcomes:
measure: Change in The International Index of Erectile Function 5
timeFrame: Change from baseline to twelve weeks after final treatment
measure: Change in The International prostate symptom score
timeFrame: Change from baseline to twelve weeks after final treatment
measure: Global satisfaction score
timeFrame: Twelve weeks after final treatment
Other outcomes:
Locations:
city: Copenhagen E
country: Denmark
facility: Birthe bonde klinikken
state: Copenhagen
Study officials:
affiliation: Urological Research Unit, Herlev Hospital
name: Anders U Frey, Bach. Med.
role: PRINCIPAL_INVESTIGATOR
References: