Lower Urinary Tract Dysfunction Clinical Trial
Aim of the study protocol is to evaluate in a prospective investigation of health statistics
if the dysfunctions of the lower urinary tract in women aged between 18 and 40 years may be
the result of past urinary pediatric dysfunction. The aim is to be able to identify the "risk
conditions" which, if treated properly in early childhood, to help avoid debilitating
problems that manifest themselves as adults and possibly to implement a strategy of
prevention.
The choice of this age group is due to the fact that it allows for easier retrieval of data,
as it is presumed that the concerned can more easily remember their history of pediatric and
/ or have parents still young enough to ask for such information. The problems of urinary
disorders in childhood era have been the subject of increased attention by pediatricians from
the end of the 70s, therefore, history taking may be more complete.
A study by Fitzgerald evaluated female subjects with mean age of 56 ± 9 years, and therefore
our study aim is to investigate an age group that does not appear in the literature to
supplement these findings, already reported.
Ultimate goal is the need to raise awareness of Pediatric Urologists to interact with adult
Urologists in order to implement a shared strategy for the management of patients with
problems of impaired bladder function in order to improve the future lower urinary tract
function.
Materials and Methods: A self administered questionnaire will be used in accordance with the
guidelines of the International Children's Continence Society. The questionnaire consists of
two parts: the first explores the history of urological clinic patient until the age of 14,in
order to evaluate any symptoms reported in a specific category of typical dysfunction of
childhood; the second part refers to the present together with urological disorders of sexual
function which, as emerges from the data of the literature may be of relevance urological
diseases detectors. The data obtained will then be subjected to statistical calculations by
which will evaluate the significance of the symptoms present in childhood in relation to
their penetrance in various forms of adult diseases dysfunctional bladder and / or sexual
abuse, with the prediction of the evolution of the same.
The questionnaire is anonymous in order to protect privacy. The questions that comprise it
have been partly extracted from the questionnaire validated by the International Children's
Society Continent and partly made by the authors of this study on the basis of the scientific
evidence.
Patients will be recruited from the outpatient clinic of the Urogynecology Urology Clinic,
University of Perugia, while the healthy controls will be recruited by submitting a
questionnaire to the women chosen to sample a healthy population of Graduate Schools found in
the framework of Urology, Pediatrics and Pediatric Surgery, University of Perugia.
The Investigators defined that the statistically significant number of healthy and
pathological subjects can not be less than 200 units per reference category.
The time duration of the collection of anamnestic data depend on the ability of the authors
of this research in finding the subjects to be analyzed.
There are no conflicts of interest to declare, no drugs or medical equipment will be tested .
| Status | Unknown status |
| Enrollment | 200 |
| Est. completion date | March 2016 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Any lower urinary tract symptoms - Female aged between 18 and 40 years Exclusion Criteria: - Age limit - Lower urinary tract infection |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Urology Unit, Sapienza University of Rome | Latina | |
| Italy | Pediatric Surgery, University of Perugia | Perugia | |
| Italy | Urogynecology Unit, Urology Clinic, University of Perugia | Perugia |
| Lead Sponsor | Collaborator |
|---|---|
| University of Roma La Sapienza | University Of Perugia |
Italy,
Falconer C, Ekman-Ordeberg G, Hilliges M, Johansson O. Decreased innervation of the paraurethral epithelium in stress urinary incontinent women. Eur J Obstet Gynecol Reprod Biol. 1997 Apr;72(2):195-8. — View Citation
Fitzgerald MP, Thom DH, Wassel-Fyr C, Subak L, Brubaker L, Van Den Eeden SK, Brown JS; Reproductive Risks for Incontinence Study at Kaiser Research Group. Childhood urinary symptoms predict adult overactive bladder symptoms. J Urol. 2006 Mar;175(3 Pt 1):989-93. — View Citation
Kuh D, Cardozo L, Hardy R. Urinary incontinence in middle aged women: childhood enuresis and other lifetime risk factors in a British prospective cohort. J Epidemiol Community Health. 1999 Aug;53(8):453-8. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | International Children Continence Society Questionnaire | Questionnaires scores at time 0 (screening time) |
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