Assessment the effect of focused extracorporeal shockwave therapy in pain management, erectile dysfunction and urinary symptoms in patients suffering from chronic pelvic pain syndrome – a randomized clinical trial
In this single center phase III clinical trial, 34 patients with diagnosis of chronic prostatitis/chronic pelvic pain syndrome (according to history and physical examination and urodynamic study) who are referred to Shohada-e-Tajrish urology clinic are enrolled. They are divided into two groups: the first group numbered 17 patients, who are treated with a combination of an a-blocker, an anti-inflammatory agent, a muscle relaxant and a short course of antibiotic treatment in combination with 4 sessions of perineal focused extracorporeal shockwave therapy (ESWT); the second group consist of 17 patients who receive a combination of sham-ESWT and the fore-mentioned triple therapy and short course of antibiotic. Patients and data analyzer are blind to data. Both groups are evaluated with NIH-CPSI, IPSS and IIEF5 questionnaires and uroflowmetry, at the beginning, 1 month and 3 months after treatment, and the results will be compared between both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082635911N1
Registration date:2017-11-17, 1396/08/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-17, 1396/08/26
Registrant information
Name
Farzad Allameh
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 6386
Email address
farzadallameh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of focused extracorporeal shockwave therapy in pain management, erectile dysfunction and urinary symptoms in patients suffering from chronic pelvic pain syndrome – a randomized clinical trial
Public title
Shock-wave therapy in men with pelvic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
>18 years old; definite diagnosis of CPPS; Symptomatic for at least 3 months; no treatment before; sign the informed consent
Exclusion criteria:
acute or chronic bacterial prostatitis; UTI in 1 recent year; history of prostate cancer or PSA>4; coagulation problems; history of hematuria, urethral stricture, urologic cancers, urolithiasis, neurogenic bladder, STDs, colorectal problems, inguinal hernia and varicocele; drug addiction
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization method: closed envelopes
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Shahid Beheshti University of Medical Sciences - School of Medicine