Overactive BladderNCT02297178
A Follow-net Investigation of a Randomised Study of Cystoscopy and Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding
An observational study of Overactive Bladder and Voiding Dysfunction, run by Medway NHS Foundation Trust.
Trial summary
Urinary incontinences is a highly prevalent and distressing condition which has a significant impact on health related quality of life in millions of women worldwide. Of all women with incontinence, 90% will have overactive bladder symptoms (OAB), and 50% will have detrusor overactivity (DO) on cystometry. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder, Voiding Dysfunction, Urinary Incontinence
- What is being tested?
- Cystoscopy only and Cystoscopy and Urethral dilatation
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Entry to the study will be offered to all women previously recruited into the original randomised controlled trial. This study is a 3 year follow up of a randomised controlled trial. Patients will be sent a letter offering a review appointment.
Who may be able to join
- Significant Overactive Bladder Symptoms
- Based on scoring 1 or 2 on the Urgency Perception Scale
- On the symptoms domain of the KHQ
- More than 8 voids per day on frequency volume chart +/- 2 or more episodes of nocturia
- Pressure flow studies demonstrate a maximum flow rate of less than 15ml on a minimum voided volume of 200ml with a high or normal detrusor pressure at maximum flow or post-void residual of 200ml or over
- Patients must be able to give informed consent for the study.
Who cannot join
- Presence of concurrent urodynamic stress incontinence.
- Patients with bladder pathology or haematuria of unknown origin.
- Patients with neurological disorders (as these may affect voiding).
- Symptomatic pelvic organ prolapse requiring intervention
- Patients with bladder pathology (including urinary tract infection) or haematuria of unknown origin
About this study
Urinary incontinences is a highly prevalent and distressing condition which has a significant impact on health related quality of life in millions of women worldwide. Of all women with incontinence, 90% will have overactive bladder symptoms (OAB), and 50% will have detrusor overactivity (DO) on cystometry. The overactive bladder syndrome is defined by the International Continence society as "Urinary urgency, with or without urge incontinence, usually with frequency and nocturia if there is a no infection or proven pathology" (Abrams et al 2002)
Initial management of OAB and DO consists of conservative measures such as altering fluid intake, bladder retraining and drug therapy. The next step consists of interventions such as cystoscopy and urethral dilatation, on the basis that it will allow intrinsic bladder problems such as interstitial cystitis to excluded, excluded, and may confer a symptomatic benefit.
The original study showed no benefit of urethral dilatation versus no dilatation at 6 months follow up (Duckett 2007). The investigators do not know the natural history of patients with voiding dysfunction. Therefore reviewing their symptoms will give a better idea of what happens to these patients symptoms over time.
Read the detailed description
Urinary incontinences is a highly prevalent and distressing condition which has a significant impact on health related quality of life in millions of women worldwide. Of all women with incontinence, 90% will have overactive bladder symptoms (OAB), and 50% will have detrusor overactivity (DO) on cystometry. The overactive bladder syndrome is defined by the International Continence society as "Urinary urgency, with or without urge incontinence, usually with frequency and nocturia if there is a no infection or proven pathology" (Abrams et al 2002)
Initial management of OAB and DO consists of conservative measures such as altering fluid intake, bladder retraining and drug therapy. The next step consists of interventions such as cystoscopy and urethral dilatation, on the basis that it will allow intrinsic bladder problems such as interstitial cystitis to excluded, excluded, and may confer a symptomatic benefit.
Cystoscopy and urethral dilatation have long been advocated as empirical treatments for women with lower urinary tract symptoms (LUTS). A review of the literature reveals a marked lack of evidence regarding the survey of practice amongst UK urologists found that 61% had performed urethral dilatation 7 or more times during the year in which the survey was conducted, although 55% believed that less than half of the patients experience long term improvement (Masarani and Willis, 2006)
The original study showed no benefit of urethral dilatation versus no dilatation at 6 months follow up (Duckett 2007). The investigators do not know the natural history of patients with voiding dysfunction. Therefore reviewing their symptoms will give a better idea of what happens to these patients symptoms over time. The aim of the study is to identify any long term benefit from urethral dilatation over cystoscopy alone.
- Being tested
- Cystoscopy only, Cystoscopy and Urethral dilatation
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cystoscopy onlyProcedure or surgery
Cystoscopy performed for investigation and treatment of OAB and voiding dysfunction
Cystoscopy and Urethral dilatationProcedure or surgery
Cystoscopy and urethral dilatation performed for investigation and treatment of OAB and voiding dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Cystoscopy Alone | Patients who received cystoscopy only for treatment of OAB and voiding dysfunction. Receives: Procedure: Cystoscopy only | |
| Cystoscopy & Urethral Dilatation | Patients who received urethral dilatation and cystoscopy for treatment of OAB and voiding dysfunction. Receives: Procedure: Cystoscopy and Urethral dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICIQ-Fluts questionnaire
To identify if there is any long term benefit from urethral dilatation over cystoscopy alone. Their baseline symptoms will be assessed and compared to those identified at baseline in the previous study.
Measured: 3 years
Secondary outcomes (3)
King's Health Questionnaire
To identify if there is any long term benefit from urethral dilatation over cystoscopy alone. Their baseline symptoms will be assessed and compared to those identified at baseline in the previous study.
Measured: 3 years
Urgency Perception Scale Questionnaire
To identify if there is any long term benefit from urethral dilatation over cystoscopy alone. Their baseline symptoms will be assessed and compared to those identified at baseline in the previous study.
Measured: 3 years
Uroflowmetry
Flow rates will be repeated in all patients allowing for an objective comparison post-operatively and 3 years later.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startAug 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Unable to recruit resaerch staff for study
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 Overactive BladderStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medway NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Jonathan Duckett, Medway NHS Foundation Trust
- Investigators
- Jonathan RA Duckett, FRCOG, MBChB, Principal investigator, Medway Maritime Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297178
- Sponsor's protocol ID
- MedwayUD
- Status last verified
- Oct 2016
- First submitted
- 11 Nov 2014
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
PubMed 11857671Duckett JR, Basu M. The predictive value of preoperative pressure-flow studies in the resolution of detrusor overactivity and overactive bladder after tension-free vaginal tape insertion. BJU Int. 2007 Jun;99(6):1439-42. doi: 10.1111/j.1464-410X.2007.06842.x. Epub 2007 Apr 5.
PubMed 17419703Masarani M, Willis RG. Urethral dilatation in women: urologists' practice patterns in the UK. Ann R Coll Surg Engl. 2006 Sep;88(5):496-8. doi: 10.1308/003588406X114884.
PubMed 17002859
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-net Investigation of a Randomised Study of Cystoscopy and Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding
- ClinicalTrials.gov ID
- NCT02297178
- Acronym / sponsor ID
- MedwayUD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to recruit resaerch staff for study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medway NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Nov 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.
Urinary incontinences is a highly prevalent and distressing condition which has a significant impact on health related quality of life in millions of women worldwide. Of all women with incontinence, 90% will have overactive bladder symptoms (OAB), and 50% will have detrusor overactivity (DO) on cystometry. The overactive bladder syndrome is defined by the International Continence society as "Urinary urgency, with or without urge incontinence, usually with frequency and nocturia if there is a no infection or proven pathology" (Abrams et al 2002)
Initial management of OAB and DO consists of conservative measures such as altering fluid intake, bladder retraining and drug therapy. The next step consists of interventions such as cystoscopy and urethral dilatation, on the basis that it will allow intrinsic bladder problems such as interstitial cystitis to excluded, excluded, and may confer a symptomatic benefit.
The original study showed no benefit of urethral dilatation versus no dilatation at 6 months follow up (Duckett 2007). The investigators do not know the natural history of patients with voiding dysfunction. Therefore reviewing their symptoms will give a better idea of what happens to these patients symptoms over time.
Detailed description
Urinary incontinences is a highly prevalent and distressing condition which has a significant impact on health related quality of life in millions of women worldwide. Of all women with incontinence, 90% will have overactive bladder symptoms (OAB), and 50% will have detrusor overactivity (DO) on cystometry. The overactive bladder syndrome is defined by the International Continence society as "Urinary urgency, with or without urge incontinence, usually with frequency and nocturia if there is a no infection or proven pathology" (Abrams et al 2002)
Initial management of OAB and DO consists of conservative measures such as altering fluid intake, bladder retraining and drug therapy. The next step consists of interventions such as cystoscopy and urethral dilatation, on the basis that it will allow intrinsic bladder problems such as interstitial cystitis to excluded, excluded, and may confer a symptomatic benefit.
Cystoscopy and urethral dilatation have long been advocated as empirical treatments for women with lower urinary tract symptoms (LUTS). A review of the literature reveals a marked lack of evidence regarding the survey of practice amongst UK urologists found that 61% had performed urethral dilatation 7 or more times during the year in which the survey was conducted, although 55% believed that less than half of the patients experience long term improvement (Masarani and Willis, 2006)
The original study showed no benefit of urethral dilatation versus no dilatation at 6 months follow up (Duckett 2007). The investigators do not know the natural history of patients with voiding dysfunction. Therefore reviewing their symptoms will give a better idea of what happens to these patients symptoms over time. The aim of the study is to identify any long term benefit from urethral dilatation over cystoscopy alone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystoscopy Alone | – | Procedure: Cystoscopy onlyPatients who received cystoscopy only for treatment of OAB and voiding dysfunction. |
| Cystoscopy & Urethral Dilatation | – | Procedure: Cystoscopy and Urethral dilatationPatients who received urethral dilatation and cystoscopy for treatment of OAB and voiding dysfunction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Entry to the study will be offered to all women previously recruited into the original randomised controlled trial. This study is a 3 year follow up of a randomised controlled trial. Patients will be sent a letter offering a review appointment.
Key inclusion criteria (6 listed)
- Significant Overactive Bladder Symptoms
- Pressure flow studies demonstrate a maximum flow rate of less than 15ml on a minimum voided volume of 200ml with a high or normal detrusor pressure at maximum flow or post-void residual of 200ml or over
- Patients must be able to give informed consent for the study.
Key exclusion criteria (5 listed)
- Presence of concurrent urodynamic stress incontinence.
- Patients with bladder pathology or haematuria of unknown origin.
- Patients with neurological disorders (as these may affect voiding).
- Symptomatic pelvic organ prolapse requiring intervention
- Patients with bladder pathology (including urinary tract infection) or haematuria of unknown origin
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 |
|---|---|---|
| Cystoscopy onlyCystoscopy performed for investigation and treatment of OAB and voiding dysfunction | Procedure or surgery | Cystoscopy Alone |
| Cystoscopy and Urethral dilatationCystoscopy and urethral dilatation performed for investigation and treatment of OAB and voiding dysfunction | Procedure or surgery | Cystoscopy & Urethral Dilatation |
Primary outcome
ICIQ-Fluts questionnaire
Time frame: 3 years
To identify if there is any long term benefit from urethral dilatation over cystoscopy alone. Their baseline symptoms will be assessed and compared to those identified at baseline in the previous study.
3 secondary outcomes
King's Health Questionnaire
Time frame: 3 years
Urgency Perception Scale Questionnaire
Time frame: 3 years
Uroflowmetry
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Results publication: PubMed 11857671Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
- Results publication: PubMed 17419703Duckett JR, Basu M. The predictive value of preoperative pressure-flow studies in the resolution of detrusor overactivity and overactive bladder after tension-free vaginal tape insertion. BJU Int. 2007 Jun;99(6):1439-42. doi: 10.1111/j.1464-410X.2007.06842.x. Epub 2007 Apr 5.
- Results publication: PubMed 17002859Masarani M, Willis RG. Urethral dilatation in women: urologists' practice patterns in the UK. Ann R Coll Surg Engl. 2006 Sep;88(5):496-8. doi: 10.1308/003588406X114884.
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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.
Jonathan RA Duckett, FRCOG, MBChB principal investigator
Medway Maritime Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder and Voiding Dysfunction, run by Medway NHS Foundation Trust.
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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
ICIQ-Fluts questionnaire (time frame: 3 years). 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 NCT02297178, 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 17 Oct 2016.