Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT02042651
Status:
WITHDRAWN
Last Update Posted:
2015-03-24
First Post:
2014-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Sham Controlled Study of the Effects of Ultrasonic Shockwaves as a Treatment for Chronic Pelvic Pain
Sponsor:
Herlev Hospital
Organization:
Study Overview
Official Title:
Low Intensity Extracorporeal Shockwave Therapy Against Chronic Pelvic Pain: a Randomized and Sham Controled Study
Status:
WITHDRAWN
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study stopped because of insuficient number of comparable patients available.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPPESWT
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HEH-2013-33 | OTHER | The danish dataprotection agency | View |