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Lower Urinary Tract DysfunctionNCT02185287

"The Urological Dysfunctions in Young Women: Inheritance of Childhood?"

An observational study of Lower Urinary Tract Dysfunction, run by University of Roma La Sapienza at 3 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Lower Urinary Tract Dysfunction
How many people
200 participants
Where
3 sitesItaly
Study dates
Apr 2013to Mar 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: 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.

Who may be able to join

  • Any lower urinary tract symptoms
  • Female aged between 18 and 40 years

Who cannot join

  • Age limit
  • Lower urinary tract infection

Trial locations and contacts

3 sites in 1 country.

Elisabetta Costantini, Associate Professor contact

elisabetta.costantini@unipg.it

Italy3 sites, 2 recruiting
  • Urology Unit, Sapienza University of Rome

    Latina, 04100

    Active, not recruiting
  • Pediatric Surgery, University of Perugia

    Perugia, 06131

    Marco Prestipino, MD, marco.prestipino@unipg.it

    Antonino Appignani, Professor, MD

    Recruiting
  • Urogynecology Unit, Urology Clinic, University of Perugia

    Perugia, 06131

    Elisabetta Costantini, Associate Professor, +390755783743, elisabetta.costantini@unipg.it

    Elisabetta Costantini, MD, Associate Professor

    Recruiting

Other trials in Italy

About this study

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.

Read more

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 .

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02185287
Study groupRoleWhat they receive
Lower urinary tract dysfunction, female, age: 18-40 yearsNot described
Healthy female subjects, age: 18-40 yearsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. International Children Continence Society Questionnaire

    Measured: Questionnaires scores at time 0 (screening time)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2014 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2014
  4. Study completionMar 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02185287
Sponsor's protocol ID
2199/13 Prot.N.1625/13/ON
Status last verified
May 2015
First submitted
1 Jul 2014
Last updated
28 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 10562862
  • 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.

    PubMed 16469599
  • 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.

    PubMed 9134401

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Urinary Tract Dysfunction, run by University of Roma La Sapienza at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elisabetta Costantini, Associate Professor (elisabetta.costantini@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Children Continence Society Questionnaire (time frame: Questionnaires scores at time 0 (screening time)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02185287, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.

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