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

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.

Study Overview

• Status: Terminated
• Conditions: Overactive Bladder; Healthy Subjects
• Intervention / Treatment: Procedure: High resolution urodynamic assessment; Procedure: Conventional urodynamic assessment

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6202
    • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: OAB subjects	Procedure: High resolution urodynamic assessment; Procedure: Conventional urodynamic assessment
Experimental: Part 2: Healthy subjects	Procedure: High resolution urodynamic assessment; Procedure: Conventional urodynamic assessment
Experimental: Part 2: OAB subjects	Procedure: High resolution urodynamic assessment; Procedure: Conventional urodynamic assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the High resolution urodynamics (Day 1)

Secondary Outcome Measures

Outcome Measure	Time Frame
Identify NVA in healthy and OAB subjects using conventional urodynamic assessment	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	During High resolution and conventional urodynamic assessments (Day 1)
Assess the correlation between NVA and subjects bladder sensations	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)	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	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	During High resolution and conventional urodynamic assessments (Day 1)

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe Ltd.
• Investigators: Study Chair: Clinical Study Manager, Astellas Pharma Europe Ltd.; Principal Investigator: Principal Investigator, Maastricht University Medical Center, Maastricht

Publications and helpful links

Helpful Links

• Link to Results on JAPIC - enter 140629 in the JapicCTI-RNo. field

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: February 13, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (Estimate): February 29, 2012

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 14, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: OAB; High Resolution Urodynamics
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 905-EC-010