Overactive Bladder SyndromeNCT05151081
Overactive Bladder Syndrome
An observational study of Overactive Bladder Syndrome and Enuresis, Nocturnal, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
Trial summary
Purpose: A lot of etiological factors related to overactive bladder (OAB) has been investigated. However, the role of primary nocturnal enuresis (NE), which is characterized with childhood night time incontinence, in the etiology of OAB is controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder Syndrome, Enuresis, Nocturnal
- What is being tested?
- basicly
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2020to 15 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: up to 18 year and all sex
Who may be able to join
- overactive bladder syndrome
- enuresis nocturna
Who cannot join
- diabetes mellitus,
- neurological diseases
- bladder outlet obstruction,
- active urinary system infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hisar Intercontinental Hospital
Istanbul, 34768
About this study
Official title: The Role of Primary Nocturnal Enuresis in the Etiology of Overactive Bladder Syndrome
Purpose:
A lot of etiological factors related to overactive bladder (OAB) has been investigated. However, the role of primary nocturnal enuresis (NE), which is characterized with childhood night time incontinence, in the etiology of OAB is controversial. This study aims to evaluate the effect of NE in patients diagnosed with OAB.
Metod Between january-september 2021, the data of patients who applied to the urology outpatientclinic with OAB symptoms were collected. Patients with a history of chronic systemic disease, previous medical treatment for OAB and who did not accept to join the study were excluded. According to the diagnosis of childhood NE, patients were divided into two groups. Demographic data hav been recorded. Frequency of incontinence, number of day time void and nocturia were evaluated according to a 3 day voiding diary. Inaddition, max. Urinary flowr atio (Qmax), bladder Wall thickness and postvoid residual volüme rates were determined using uroflowmetry and pelvic ultrasound.
Read the detailed description
A prospective randomized study is a study based on basic urological data. This study aims to evaluate the effect of NE in patients diagnosed with OAB.
- Conditions
- Overactive Bladder Syndrome, Enuresis, Nocturnal
- Being tested
- basicly
- Keywords
- Overactive bladder, Enuresis nocturna, treatment, etiology
- Medical subject headings
- Nocturnal Enuresis, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
basiclyOther
Do not repeat information already included in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Enuresis, Non-Enuresis | Patients were divided into two gruops according to whether having NE or not during childhood Receives: Other: basicly |
What is being measured
The primary outcome is the main question the study is designed to answer.
A diagnose of childhood NE in OAB patients can cause more severe semptomatologic progression
This study aims to evaluate the effect of NE in patients diagnosed with OAB.Definition of NE is urinary incontinence in children over the age of 5 during sleep ,as defined by International Children's Continence Society.
Overactive Bladder Symptom Score (OABSS) questionnaire were used for the assessment of OAB. OABSS is an questionnaire ,consisting of 4 questions, was prepared by Homma et al. in 2006
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start3 Feb 2020
- Primary completion3 Jul 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basri Cakiroglu, Hisar Intercontinental Hospital
- Investigators
- Basri Cakiroglu, Study chair, Hisar Intercontinental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151081
- Sponsor's protocol ID
- 2020/04
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Primary Nocturnal Enuresis in the Etiology of Overactive Bladder Syndrome
- ClinicalTrials.gov ID
- NCT05151081
- Acronym / sponsor ID
- 2020/04
- Conditions
- Overactive Bladder Syndrome, Enuresis, Nocturnal
- Keywords
- Overactive bladder, Enuresis nocturna, treatment, etiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 3 Jul 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 9 Dec 2021 (actual)
- 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.
Purpose:
A lot of etiological factors related to overactive bladder (OAB) has been investigated. However, the role of primary nocturnal enuresis (NE), which is characterized with childhood night time incontinence, in the etiology of OAB is controversial. This study aims to evaluate the effect of NE in patients diagnosed with OAB.
Metod Between january-september 2021, the data of patients who applied to the urology outpatientclinic with OAB symptoms were collected. Patients with a history of chronic systemic disease, previous medical treatment for OAB and who did not accept to join the study were excluded. According to the diagnosis of childhood NE, patients were divided into two groups. Demographic data hav been recorded. Frequency of incontinence, number of day time void and nocturia were evaluated according to a 3 day voiding diary. Inaddition, max. Urinary flowr atio (Qmax), bladder Wall thickness and postvoid residual volüme rates were determined using uroflowmetry and pelvic ultrasound.
Detailed description
A prospective randomized study is a study based on basic urological data. This study aims to evaluate the effect of NE in patients diagnosed with OAB.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enuresis, Non-Enuresis | – | Other: basiclyPatients were divided into two gruops according to whether having NE or not during childhood |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- up to 18 year and all sex
Key inclusion criteria (2 listed)
- overactive bladder syndrome
- enuresis nocturna
Key exclusion criteria (4 listed)
- diabetes mellitus,
- neurological diseases
- bladder outlet obstruction,
- active urinary system infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| basiclyDo not repeat information already included in arm/group descriptions. | Other | Enuresis, Non-Enuresis |
Primary outcome
A diagnose of childhood NE in OAB patients can cause more severe semptomatologic progression
Time frame: 1 years
This study aims to evaluate the effect of NE in patients diagnosed with OAB.Definition of NE is urinary incontinence in children over the age of 5 during sleep ,as defined by International Children's Continence Society. Overactive Bladder Symptom Score (OABSS) questionnaire were used for the assessment of OAB. OABSS is an questionnaire ,consisting of 4 questions, was prepared by Homma et al. in 2006
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Basri Cakiroglu study chair
Hisar Intercontinental Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder Syndrome and Enuresis, Nocturnal, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A diagnose of childhood NE in OAB patients can cause more severe semptomatologic progression (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2021.