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.
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
Italy3 sites, 2 recruiting
- Active, not recruiting
Urology Unit, Sapienza University of Rome
Latina, 04100
- 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
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 .
- Conditions
- Lower Urinary Tract Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lower urinary tract dysfunction, female, age: 18-40 years | Not described | |
| Healthy female subjects, age: 18-40 years | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted9 Jul 2014 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- University Of Perugia
- Responsible party
- Principal investigator, Antonio Luigi Pastore, University of Roma La Sapienza
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 10562862Fitzgerald 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 16469599Falconer 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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Urological Dysfunctions in Young Women: Inheritance of Childhood?"
- ClinicalTrials.gov ID
- NCT02185287
- Acronym / sponsor ID
- 2199/13 Prot.N.1625/13/ON
- Conditions
- Lower Urinary Tract Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- University Of Perugia
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2016 (estimated)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower urinary tract dysfunction, female, age: 18-40 years | – | – |
| Healthy female subjects, age: 18-40 years | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Any lower urinary tract symptoms
- Female aged between 18 and 40 years
Key exclusion criteria (2 listed)
- Age limit
- Lower urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
International Children Continence Society Questionnaire
Time frame: Questionnaires scores at time 0 (screening time)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 10562862Kuh 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.
- Background: PubMed 16469599Fitzgerald 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.
- Background: PubMed 9134401Falconer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabetta Costantini, Associate Professor contact
3 sites in 1 country: see every site and its status.
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.