Urinary Incontinence, UrgeNCT01971437
Cystoscopy and Cystodistension; Therapeutic and Aetiological Aspect in Overactive Bladder
A study testing Cystodistension & Cystoscopy in people with Urinary Incontinence, Urge, run by Medway NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is an ethically approved randomised controlled study looking at whether Cystodistension(filling the bladder with fluid under pressure) provides any benefit over cystoscopy alone (looking in the bladder) in women with refractory overactive bladder. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urge
- What is being tested?
- Cystodistension & Cystoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Mar 2016
- Phase
- Interventional
- 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
Who may be able to join
- Women with only OAB symptoms
- Women who have failed bladder drill and anticholinergic agents
- Women who stopped medication due to side-effects or lack of efficacy
- Currently receiving no treatment
Who cannot join
- Patients with co-existing urodynamic stress incontinence
- Patients with neurological diseases
- Patients with pre-existing voiding dysfunction
- Free flow rate <5th centile or equivalent reduced pressure flow rate OR
- Post-void residual volume greater than 100ml
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Medway Maritime Hospital
Gillingham, Kent, Me7 5NY
About this study
Official title: A Randomised Study of Cystoscopy and Cystodistension Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome.
This is an ethically approved randomised controlled study looking at whether Cystodistension(filling the bladder with fluid under pressure) provides any benefit over cystoscopy alone (looking in the bladder) in women with refractory overactive bladder. Urine samples will also be assessed for underlying infected cause of OAB using urinalysis, microscopy and culture and cytokine assays (In collaboration with the University of Kent). We hypothesize that Cystodistension has a therapeutic benefit to women with refractory OAB and the there is an increase prevalence in chronic urinary infections with raised cytokines in women with refractory OAB.
Read the detailed description
We aim to measure outcomes initially, 6 weels and 6months follow-up.
- Resolution measured by Urgency Perception Scale (UPS). Resolution of urgency will be assessed with the UPS. The numbers of women with a Level 3 UPS score (hold and finish task) will be compared using Chi square test in patients treated with cystodistension vs non cystodistension arms.
- Change in quality of life status determined by quality of life questionnaires will ismilarly be comapred between the 2 arms of the study.
- Change in urinary symptoms defined by Patient's Perception of Intensity Scale. Change in uregncy scores will be compared between the 2 arms of the study.
Secondary Outcome Measure:1. Prevalence of chronic urinary infection and organisms in patients with refractory OAB 2. To identify whether urinary cytokines are present in a higher proportion of patients with OAB.
Inclusion Criteria
- Women with only OAB symptoms
- Women who have failed bladder drill and anticholinergic agents
- Women who stopped medication due to side-effects or lack of efficacy
- Currently receiving no treatment
Exclusion Criteria
- Patient with co-existing urodynamic stress incontinence
- Patients with neurological diseases
- Patients with pre-existing voiding dysfunction
- Conditions
- Urinary Incontinence, Urge
- Being tested
- Cystodistension & Cystoscopy
- Keywords
- Overactive Bladder, OAB, Cystoscopy, Cystodistension, UTI, Cytokines
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cystodistension & CystoscopyProcedure or surgery
Also called Cystodistension, Cystoscopy, OAB, Treatments
Women with refractory OAB receiving Cystoscopy and cystodistension
| Study group | Role | What they receive |
|---|---|---|
| Cystodistension & Cystoscopy Arm | Experimental | This is the Arm receiving cystodistension and cystoscopy due to refractory OAB. Receives: Procedure: Cystodistension & Cystoscopy |
| Cystoscopy Arm | Placebo comparator | This is the arm that receives cystoscopy only in women with refractory OAB. Receives: Procedure: Cystodistension & Cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the presence of urgency and urge incontinence initially, 6 weeks and 6 months
- Resolution measured by Urgency Perception Scale.
- Change in quality of life status.
- Change in urinary symptoms defined by the Patient's Perception of Intensity Scale
Measured: 12-18months
Secondary outcomes (1)
Improved quality of life.
Change in quality of life status, Urgency Perception Scale and Patient's Perception of Intensity Scale scoring initially, 6 weeks and 6 months.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, UrgeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 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, Principal investigator, Medway NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971437
- Sponsor's protocol ID
- TBC
- Status last verified
- Mar 2016
- First submitted
- 21 Oct 2013
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study of Cystoscopy and Cystodistension Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome.
- ClinicalTrials.gov ID
- NCT01971437
- Acronym / sponsor ID
- TBC
- Conditions
- Urinary Incontinence, Urge
- Keywords
- Overactive Bladder, OAB, Cystoscopy, Cystodistension, UTI, Cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medway NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Oct 2013 (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.
This is an ethically approved randomised controlled study looking at whether Cystodistension(filling the bladder with fluid under pressure) provides any benefit over cystoscopy alone (looking in the bladder) in women with refractory overactive bladder. Urine samples will also be assessed for underlying infected cause of OAB using urinalysis, microscopy and culture and cytokine assays (In collaboration with the University of Kent). We hypothesize that Cystodistension has a therapeutic benefit to women with refractory OAB and the there is an increase prevalence in chronic urinary infections with raised cytokines in women with refractory OAB.
Detailed description
We aim to measure outcomes initially, 6 weels and 6months follow-up.
- Resolution measured by Urgency Perception Scale (UPS). Resolution of urgency will be assessed with the UPS. The numbers of women with a Level 3 UPS score (hold and finish task) will be compared using Chi square test in patients treated with cystodistension vs non cystodistension arms.
- Change in quality of life status determined by quality of life questionnaires will ismilarly be comapred between the 2 arms of the study.
- Change in urinary symptoms defined by Patient's Perception of Intensity Scale. Change in uregncy scores will be compared between the 2 arms of the study.
Secondary Outcome Measure:1. Prevalence of chronic urinary infection and organisms in patients with refractory OAB 2. To identify whether urinary cytokines are present in a higher proportion of patients with OAB.
Inclusion Criteria
- Women with only OAB symptoms
- Women who have failed bladder drill and anticholinergic agents
- Women who stopped medication due to side-effects or lack of efficacy
- Currently receiving no treatment
Exclusion Criteria
- Patient with co-existing urodynamic stress incontinence
- Patients with neurological diseases
- Patients with pre-existing voiding dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystodistension & Cystoscopy Arm | Experimental | Procedure: Cystodistension & CystoscopyThis is the Arm receiving cystodistension and cystoscopy due to refractory OAB. |
| Cystoscopy Arm | Placebo comparator | Procedure: Cystodistension & CystoscopyThis is the arm that receives cystoscopy only in women with refractory OAB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women with only OAB symptoms
- Women who have failed bladder drill and anticholinergic agents
- Women who stopped medication due to side-effects or lack of efficacy
- Currently receiving no treatment
Key exclusion criteria (5 listed)
- Patients with co-existing urodynamic stress incontinence
- Patients with neurological diseases
- Patients with pre-existing voiding dysfunction
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 |
|---|---|---|
| Cystodistension & CystoscopyAlso: Cystodistension, Cystoscopy, OAB, TreatmentsWomen with refractory OAB receiving Cystoscopy and cystodistension | Procedure or surgery | Cystodistension & Cystoscopy Arm, Cystoscopy Arm |
Primary outcome
To assess the presence of urgency and urge incontinence initially, 6 weeks and 6 months
Time frame: 12-18months
1. Resolution measured by Urgency Perception Scale. 2. Change in quality of life status. 3. Change in urinary symptoms defined by the Patient's Perception of Intensity Scale
1 secondary outcome
Improved quality of life.
Time frame: 12-18 months
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 22 Mar 2016.
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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 principal investigator
Medway NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cystodistension & Cystoscopy in people with Urinary Incontinence, Urge, run by Medway NHS Foundation Trust at 1 site in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 22 Mar 2016. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
To assess the presence of urgency and urge incontinence initially, 6 weeks and 6 months (time frame: 12-18months). 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 22 Mar 2016.