UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005456 |
|---|---|
| Receipt number | R000006471 |
| Scientific Title | THE ROLE OF LIFE STYLE AND DIET MODIFICATIONS ON TREATMENT OF CHRONIC PELVIC PAIN SYNDROME |
| Date of disclosure of the study information | 2011/04/18 |
| Last modified on | 2011/05/05 20:47:23 |
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Basic information
Public title
THE ROLE OF LIFE STYLE AND DIET MODIFICATIONS ON TREATMENT OF CHRONIC PELVIC PAIN SYNDROME
Acronym
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
Scientific Title:Acronym
THE ROLE OF LIFE STYLE AND DIET MODIFICATIONS ON TREATMENT OF CHRONIC PELVIC PAIN SYNDROME
Region
| Europe |
Condition
Condition
Chronic pelvic pain syndrome (CPPS)
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objective of the present study are:
1) to review medical literature about risk factors for prostatitis coming from
abnormal lifestyle and dietary habits.
2) to prepare a vademecum of lifestyle and diet modifications based on scientific evidences.
3) to investigate the incidence of these risk factors in a population of patients coming to our centre complaining of CPPS. 4) to investigate the effectiveness and the compliance to this vademecum associated to the most common therapy actually used for prostatite like NSAIDs and phitotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in the mean total NIH Chronic Prostatitis Symptom Index (NIH-CPSI) scores of the two groups from baseline to after three months of treatment.
Key secondary outcomes
The change in mean NIH- CPSI subdomains (pain, micturition, QoL) of the two groups pre- and aftertreatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
- Nimesulide 100 mg bidaly for a week
- Serenoa repens (Saw Palmetto) 320 mg one tablet each day for three months
- Modification of diet and life-style change
Interventions/Control_2
- Nimesulide 100 mg bidaly for a week
- Serenoa repens (Saw Palmetto) 320 mg one tablet each day for three months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 50 | years-old | > |
Gender
Male
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.
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.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Luigi Gallo |
Organization
Studio Urologico Gallo
Division name
Urology
Zip code
Address
Via Santa Lucia 97 80132 Naples Italy
TEL
+390817649530
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Luigi Gallo |
Organization
Studio Urologico Gallo
Division name
Urology
Zip code
Address
Via Santa Lucia 97 80132 Naples Italy
TEL
+390817649530
Homepage URL
http://www.studiourologicogallo.it/
info@studiourologicogallo.it
Sponsor or person
Institute
Studio Urologico Gallo
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Studio Urologico Gallo
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 18 | Day |
Last modified on
| 2011 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006471
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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