Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000441910
Ethics application status
Approved
Date submitted
14/04/2011
Date registered
29/04/2011
Date last updated
27/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of life style and diet modifications on treatment of chronic pelvic pain syndrome
Scientific title
The role of life style and diet modifications on treatment of chronic pelvic pain syndrome
Secondary ID [1] 259999 0
not assigned
Universal Trial Number (UTN)
not assigned
Trial acronym
not assigned
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pelvic pain syndrome 265654 0
chronic prostatitis 265689 0
Condition category
Condition code
Renal and Urogenital 265786 265786 0 0
Pelvic inflammatory disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Nimesulide 100 mg bidaily for one week
2) Serenoa Repens (Saw Palmetto) one 320 mg tablet each day for three months.
Saw palmetto is an extract of the fruit of Serenoa Repens: it is a phytotherapic agent commonly used worldwide for prostatic conditions. Its effectiveness for prostatitis was already showed in many clinical trials.
3) Intervention: modification of lifestyle and diet for three months.
patients belonging the interventional arm are strongly recommended to strictly follow some lifestyle rules and dietary recommendations giving them a list prepared by Dr. Luigi Gallo, (MD specialist un urologist) including the following:
Modifications of diet:
avoidance of alcohol beverages, sodas, spicy foods, pepper, chilli, coffee, artificial sweeteners, tea.
Modifications of lifestyle:
1) Walking and practicing relaxing sport activities (swimming, jogging, free exercises).
2) regular sexual activity:
a)avoidance of sexual abstinence for more than 4 days b)Do not try to delay ejaculation in both masturbation and intercourse
c)Do not practice interrupted coitus as contraceptive method.
d)Do not have two ejacultations during the same day
3) Avoidance of sitting position for long time
4) Avoidance of sports that can be traumatic for the prostate (bicycling, motorcycling, horse riding etc.)
5) Avoidance of wearing tight underpants or trousers
At second consultation (at the end of 3 months) patients assigned to this group will be invited to refill a questionnaire assessing the grade of acceptance to lifestyle modifications. Only the patients who will correctly follow lifestyle recommendations will be considered for outcome measurements, the others will be excluded.
Intervention code [1] 264416 0
Lifestyle
Intervention code [2] 264450 0
Other interventions
Comparator / control treatment
1) Nimesulide 100 mg bidaily for one week
2) Serenoa Repens (Saw Palmetto) one 320 mg tablet each day for three months
3) no lifestyle change:
the patients included in the control group are invited to follow the same diet and the same life style of the previous months.
The patients of this group follow their regular lifestyle and undergo no modification
Control group
Active

Outcomes
Primary outcome [1] 266539 0
The change in the mean total NIH-CPSI scores of the two groups from baseline to after three months of treatment.
Timepoint [1] 266539 0
3 months
Secondary outcome [1] 273996 0
The change in mean NIH- CPSI subdomains (pain, micturition, QoL) of the two groups pre- and aftertreatment.
Timepoint [1] 273996 0
3 months

Eligibility
Key inclusion criteria
1) patients coming to our center with a diagnosis of Category IIIa or IIIb CPPS (with or without presence of leukocytes)
2) age between 20 and 50 years
3) a score of > 1 in pain domain of NIH-CPSI
4) duration of symptoms for more than 3 months
5) presence at clinical history of at least one lifestyle or diet risk factors.
Minimum age
20 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) diagnosis of a bacterial form of prostatitis (category I and II of NIH) assessed after lower urinary tract localisation studies
2) a previous urinary tract infection within the last year
3) assumption of drugs which could modify lower urinary tract function during the previous three months
4) Severe gastric problems , coagulation problems, renal and/or epatic failure contraindicating assumption of NSAIDs.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruited patients will be assigned to two different groups according to the baseline value of NIH-CPSI , age, duration of symptoms and numbers of risk factors.
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation according to baseline value of NIH-CPSI , age, duration of symptoms and numbers of risk factors.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3384 0
Italy
State/province [1] 3384 0
Campania

Funding & Sponsors
Funding source category [1] 264886 0
Self funded/Unfunded
Name [1] 264886 0
Studio Urologico Gallo
Country [1] 264886 0
Italy
Primary sponsor type
Other
Name
Studio Urologico Gallo
Address
Via Santa Lucia 97
80132
Naples
Italy
Country
Italy
Secondary sponsor category [1] 263987 0
None
Name [1] 263987 0
Address [1] 263987 0
Country [1] 263987 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266842 0
Studio Urologico Gallo
Ethics committee address [1] 266842 0
Ethics committee country [1] 266842 0
Italy
Date submitted for ethics approval [1] 266842 0
Approval date [1] 266842 0
15/07/2010
Ethics approval number [1] 266842 0
---

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32489 0
Address 32489 0
Country 32489 0
Phone 32489 0
Fax 32489 0
Email 32489 0
Contact person for public queries
Name 15736 0
Luigi Gallo
Address 15736 0
Via Santa Lucia 97
80132 Naples
Country 15736 0
Italy
Phone 15736 0
0039-081-7649530
Fax 15736 0
0039-081-7649530
Email 15736 0
[email protected]
Contact person for scientific queries
Name 6664 0
Luigi Gallo
Address 6664 0
Via Santa Lucia 97
80132 Naples
Country 6664 0
Italy
Phone 6664 0
0039-081-7649530
Fax 6664 0
0039-081-7649530
Email 6664 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.