"The Urological Dysfunctions in Young Women: Inheritance of Childhood?"
NCT ID: NCT02185287
Last Updated: 2015-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2013-04-30
2016-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 .
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Incidence of Symptomatic and Asymptomatic Bacteriuria After Urodynamic Study in Women
NCT03106103
Quality of Life Analysis in Bladder Pain Syndrome/Interstitial Cystitis
NCT05630742
Adverse Childhood Experiences in Urogynecologic Patients
NCT03480477
Risk Factors for Recurrent Urinary Tract Infection in Children
NCT00528476
Validation of Bladder Health Instrument for Evaluation in Women
NCT04016298
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lower urinary tract dysfunction, female, age: 18-40 years
No interventions assigned to this group
Healthy female subjects, age: 18-40 years
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Female aged between 18 and 40 years
Exclusion Criteria
* Lower urinary tract infection
18 Years
40 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Of Perugia
OTHER
University of Roma La Sapienza
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Antonio Luigi Pastore
Assistant Professor, MD, PhD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Urology Unit, Sapienza University of Rome
Latina, , Italy
Pediatric Surgery, University of Perugia
Perugia, , Italy
Urogynecology Unit, Urology Clinic, University of Perugia
Perugia, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1136/jech.53.8.453.
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. doi: 10.1016/S0022-5347(05)00416-7.
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. doi: 10.1016/s0301-2115(96)02685-1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2199/13 Prot.N.1625/13/ON
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.