Healthy SubjectsPhase 1NCT01540786
An Exploratory Study to Investigate Bladder Contractions in the Storage Phase and Related Bladder Sensations in Healthy Females and Females With Overactive Bladder (OAB) Using High Resolution and Conventional Urodynamics
A Phase 1 study testing High resolution urodynamic assessment and Conventional urodynamic assessment in people with Healthy Subjects and Overactive Bladder, run by Astellas Pharma Europe Ltd. at 1 site in Netherlands.
Trial summary
This study aims to identify differences in bladder contractions during the storage phase (non voiding activities) between OAB subjects and healthy subjects, using high resolution urodynamics. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Overactive Bladder
- What is being tested?
- High resolution urodynamic assessment and Conventional urodynamic assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Jun 2012
- Phase
- Phase 1
- 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OAB Subjects
- Has history of signs and symptoms of OAB including urinary frequency, urgency or urge incontinence for greater than or equal to 3 months
- At enrolment visit (V2) the subjects must have:
- At least 1 episode of urgency with or without incontinence in the last 3-day micturition diary
- Frequency of micturition greater than or equal to 8 per 24 hours period during the 3-day micturition diary period
- At the screening visit, the subject should be either naïve to OAB treatment (e.g no prior history of medications to treat lower urinary tract symptoms (LUTS), including OAB) or currently on treatment for LUTS (including OAB) and is willing to undergo a washout period for 3 weeks
Show all 26Show fewer
- Main Exclusion criteria:
- Healthy subjects
- History of lower urinary tract symptoms (LUTS), including OAB
- History of stress urinary incontinence, urethral sphincter incompetence and neurogenic detrusor overactivity
- History of signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis)
- History of bladder outlet obstruction (not including detrusor-overactivity) for example bladder/vesicouterine pro-lapse (> grade II) or chronic obstruction
- History of urinary tract surgery less than or equal to 6 months prior to screening
- Has an indwelling catheter or permanent catheter fitted
- History of pelvic area radiotherapy treatment
- Uncontrolled diabetes mellitus
- History of fibromyalgia
- Pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants, injectable contraceptives, sexual abstinence or vasectomized partner)
- Pregnancy within 6 months before screening or breast feeding within 3 months before screening
- History of a positive hepatitis A, B surface antigen, hepatitis C antibody or HIV test result.
- Any use of drugs of abuse within 3 months prior to screening visit.
- History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to screening visit
- History of drinking more than 14 units of alcohol per week (1 unit = 10 g pure alcohol = 250 ml of beer (5%) or 35 ml of spirits (35%) or 100 ml of wine (12%) within 3 months prior to screening visit
- Is currently receiving or has a history of treatment with alpha blockers, beta receptor blockers or agonists, botulinum toxin (less than 12 months), resiniferatoxin or pelvic floor muscle relaxants less than or equal to 9 months prior to screening
- Main exclusion criteria OAB subjects
- Refer to healthy subjects exclusion criteria number 2 to 16
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study to Evaluate Bladder Contractions in the Storage Phase (Non Voiding Activities) and Related Bladder Sensation in Healthy Females and Untreated Females With Overactive Bladder ("OAB") Using High Resolution and Conventional Urodynamics
This study aims to identify differences in bladder contractions during the storage phase (non voiding activities) between OAB subjects and healthy subjects, using high resolution urodynamics.
The study is divided into two parts:
- PART 1: Consists of 5 females with overactive bladder
- PART 2: Consists of 25 females with overactive bladder and 15 healthy females
Part 1 subjects will be enrolled followed by part 2 subjects. The data from part 1 subjects will be reviewed and analysed by a group of experts before starting the second part (part 2) of the study.
Read the detailed description
The subjects will complete a total of 2 visits and a follow up telephone call (or visit at the investigator's discretion).
Upon meeting eligibility criteria subjects will be screened and complete visit at hospital (Visit 1). They will then be asked to complete procedures such micturition diary, questionnaires and if applicable discontinued their ongoing OAB medication. Upon confirmation of eligibility criteria subjects will then be enrolled and complete visit 2 within 6 to 31 days post V1. At Visit 2 subjects will complete high resolution urodynamic assessment followed by the conventional urodynamic assessment. The visit will take approximately half a day. Safety follow up phone call (or visit at investigator's discretion) will take place 4 to 6 days post visit 2.
- Conditions
- Healthy Subjects, Overactive Bladder
- Being tested
- High resolution urodynamic assessment, Conventional urodynamic assessment
- Keywords
- OAB, High Resolution Urodynamics
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution urodynamic assessmentProcedure or surgery
Conventional urodynamic assessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Part 1: OAB subjects | Experimental | Not described Receives: Procedure: High resolution urodynamic assessment; Procedure: Conventional urodynamic assessment |
| Part 2: Healthy subjects | Experimental | Not described Receives: Procedure: High resolution urodynamic assessment; Procedure: Conventional urodynamic assessment |
| Part 2: OAB subjects | Experimental | Not described Receives: Procedure: High resolution urodynamic assessment; Procedure: Conventional urodynamic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify objective parameters to characterize Non Voiding Activity (NVA) in healthy and OAB subjects using high resolution urodynamic assessment
NVA is defined as changes of pressure in the bladder lumen. These changes are measured as detrusor pressure (Pdet) calculated from substraction of intra-abdominal pressure (Pabd) from intra-vesical pressure (Pves). All Pdet with an amplitude of at least 1cm of water, frequency below 0.2 Hz and pulse duration between 5 and 60 seconds qualify as NVA.
Measured: During the High resolution urodynamics (Day 1)
Secondary outcomes (6)
Identify NVA in healthy and OAB subjects using conventional urodynamic assessment
Measured: During High resolution and conventional urodynamic (Day 1) assessments
Assess the subjects bladder sensations measured by visual analogue scale (VAS) and 5-points categorical scale (Appendix 8 & 7) during the high resolution urodynamic and conventional assessments
Measured: During High resolution and conventional urodynamic assessments (Day 1)
Assess the correlation between NVA and subjects bladder sensations
Measured: During High resolution and conventional urodynamic assessments (Day 1)
Explore NVA in a subgroup of subjects defined by the severity of OAB symptoms collected as background information (3-days bladder diary)
Measured: During High resolution and conventional urodynamic assessments (Day 1)
Illustrate the amount of NVA detected with high resolution urodynamic test methodology compared to NVA detected with conventional urodynamic assessments
Measured: During High resolution and conventional urodynamic assessments (Day 1)
Assess symptoms severity, bother and its impact on quality of life using: OAB-Q short form and Urogenital Distress Inventory (UDI-6) questionnaires and a 3-Day micturition bladder diary as background information to characterize the study population
Measured: During High resolution and conventional urodynamic assessments (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: It was decided to discontinue the study due to insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study chair, Astellas Pharma Europe Ltd.Principal Investigator, Principal investigator, Maastricht University Medical Center, Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540786
- Sponsor's protocol ID
- 905-EC-010
- Status last verified
- Oct 2014
- First submitted
- 13 Feb 2012
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate Bladder Contractions in the Storage Phase (Non Voiding Activities) and Related Bladder Sensation in Healthy Females and Untreated Females With Overactive Bladder ("OAB") Using High Resolution and Conventional Urodynamics
- ClinicalTrials.gov ID
- NCT01540786
- Acronym / sponsor ID
- 905-EC-010
- Conditions
- Healthy Subjects, Overactive Bladder
- Keywords
- OAB, High Resolution Urodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was decided to discontinue the study due to insufficient recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Feb 2012 (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 study aims to identify differences in bladder contractions during the storage phase (non voiding activities) between OAB subjects and healthy subjects, using high resolution urodynamics.
The study is divided into two parts:
- PART 1: Consists of 5 females with overactive bladder
- PART 2: Consists of 25 females with overactive bladder and 15 healthy females
Part 1 subjects will be enrolled followed by part 2 subjects. The data from part 1 subjects will be reviewed and analysed by a group of experts before starting the second part (part 2) of the study.
Detailed description
The subjects will complete a total of 2 visits and a follow up telephone call (or visit at the investigator's discretion).
Upon meeting eligibility criteria subjects will be screened and complete visit at hospital (Visit 1). They will then be asked to complete procedures such micturition diary, questionnaires and if applicable discontinued their ongoing OAB medication. Upon confirmation of eligibility criteria subjects will then be enrolled and complete visit 2 within 6 to 31 days post V1. At Visit 2 subjects will complete high resolution urodynamic assessment followed by the conventional urodynamic assessment. The visit will take approximately half a day. Safety follow up phone call (or visit at investigator's discretion) will take place 4 to 6 days post visit 2.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: OAB subjects | Experimental | Procedure: High resolution urodynamic assessment, Procedure: Conventional urodynamic assessment |
| Part 2: Healthy subjects | Experimental | Procedure: High resolution urodynamic assessment, Procedure: Conventional urodynamic assessment |
| Part 2: OAB subjects | Experimental | Procedure: High resolution urodynamic assessment, Procedure: Conventional urodynamic assessment |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- OAB Subjects
- Has history of signs and symptoms of OAB including urinary frequency, urgency or urge incontinence for greater than or equal to 3 months
- At enrolment visit (V2) the subjects must have:
- At the screening visit, the subject should be either naïve to OAB treatment (e.g no prior history of medications to treat lower urinary tract symptoms (LUTS), including OAB) or currently on treatment for LUTS (including OAB) and is willing to undergo a washout period for 3 weeks
- Healthy subjects
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| High resolution urodynamic assessment | Procedure or surgery | Part 1: OAB subjects, Part 2: Healthy subjects, Part 2: OAB subjects |
| Conventional urodynamic assessment | Procedure or surgery | Part 1: OAB subjects, Part 2: Healthy subjects, Part 2: OAB subjects |
Primary outcome
Identify objective parameters to characterize Non Voiding Activity (NVA) in healthy and OAB subjects using high resolution urodynamic assessment
Time frame: During the High resolution urodynamics (Day 1)
NVA is defined as changes of pressure in the bladder lumen. These changes are measured as detrusor pressure (Pdet) calculated from substraction of intra-abdominal pressure (Pabd) from intra-vesical pressure (Pves). All Pdet with an amplitude of at least 1cm of water, frequency below 0.2 Hz and pulse duration between 5 and 60 seconds qualify as NVA.
6 secondary outcomes
Identify NVA in healthy and OAB subjects using conventional urodynamic assessment
Time frame: During High resolution and conventional urodynamic (Day 1) assessments
Assess the subjects bladder sensations measured by visual analogue scale (VAS) and 5-points categorical scale (Appendix 8 & 7) during the high resolution urodynamic and conventional assessments
Time frame: During High resolution and conventional urodynamic assessments (Day 1)
Assess the correlation between NVA and subjects bladder sensations
Time frame: During High resolution and conventional urodynamic assessments (Day 1)
Explore NVA in a subgroup of subjects defined by the severity of OAB symptoms collected as background information (3-days bladder diary)
Time frame: During High resolution and conventional urodynamic assessments (Day 1)
Illustrate the amount of NVA detected with high resolution urodynamic test methodology compared to NVA detected with conventional urodynamic assessments
Time frame: During High resolution and conventional urodynamic assessments (Day 1)
Assess symptoms severity, bother and its impact on quality of life using: OAB-Q short form and Urogenital Distress Inventory (UDI-6) questionnaires and a 3-Day micturition bladder diary as background information to characterize the study population
Time frame: During High resolution and conventional urodynamic assessments (Day 1)
Results and safety
The study was stopped early (reason given: It was decided to discontinue the study due to insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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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.
Clinical Study Manager study chair
Astellas Pharma Europe Ltd.
Principal Investigator principal investigator
Maastricht University Medical Center, Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High resolution urodynamic assessment and Conventional urodynamic assessment in people with Healthy Subjects and Overactive Bladder, run by Astellas Pharma Europe Ltd. at 1 site in Netherlands.
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 26 inclusion and 0 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: stopped early, as of the sponsor's last update on 15 Oct 2014. 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 Netherlands. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: It was decided to discontinue the study due to insufficient recruitment). Results are not available in the source record.
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?
Identify objective parameters to characterize Non Voiding Activity (NVA) in healthy and OAB subjects using high resolution urodynamic assessment (time frame: During the High resolution urodynamics (Day 1)). 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 15 Oct 2014.