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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

Primary Purpose

Healthy Subjects, Overactive Bladder

Status
Terminated
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
High resolution urodynamic assessment
Conventional urodynamic assessment
Sponsored by
Astellas Pharma Europe Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Healthy Subjects focused on measuring OAB, High Resolution Urodynamics

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part 1: OAB subjects

Part 2: Healthy subjects

Part 2: OAB subjects

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Identify NVA in healthy and OAB subjects using conventional urodynamic assessment
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
Assess the correlation between NVA and subjects bladder sensations
Explore NVA in a subgroup of subjects defined by the severity of OAB symptoms collected as background information (3-days bladder diary)
Illustrate the amount of NVA detected with high resolution urodynamic test methodology compared to NVA detected with conventional urodynamic assessments
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

Full Information

First Posted
February 13, 2012
Last Updated
October 14, 2014
Sponsor
Astellas Pharma Europe Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01540786
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
It was decided to discontinue the study due to insufficient recruitment
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Overactive Bladder
Keywords
OAB, High Resolution Urodynamics

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: OAB subjects
Arm Type
Experimental
Arm Title
Part 2: Healthy subjects
Arm Type
Experimental
Arm Title
Part 2: OAB subjects
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
High resolution urodynamic assessment
Intervention Type
Procedure
Intervention Name(s)
Conventional urodynamic assessment
Primary Outcome Measure Information:
Title
Identify objective parameters to characterize Non Voiding Activity (NVA) in healthy and OAB subjects using high resolution urodynamic assessment
Description
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.
Time Frame
During the High resolution urodynamics (Day 1)
Secondary Outcome Measure Information:
Title
Identify NVA in healthy and OAB subjects using conventional urodynamic assessment
Time Frame
During High resolution and conventional urodynamic (Day 1) assessments
Title
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)
Title
Assess the correlation between NVA and subjects bladder sensations
Time Frame
During High resolution and conventional urodynamic assessments (Day 1)
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Manager
Organizational Affiliation
Astellas Pharma Europe Ltd.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Organizational Affiliation
Maastricht University Medical Center, Maastricht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6202
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140629 in the JapicCTI-RNo. field

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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

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