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

NCT01540786 | Terminated Phase 1 DMC

• 1 other identifier: 905-EC-010
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects; Overactive Bladder

Keywords

OAB; High Resolution Urodynamics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

Study Arms (3)

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

Interventions

High resolution urodynamic assessment PROCEDURE

Part 1: OAB subjects; Part 2: Healthy subjects; Part 2: OAB subjects

Conventional urodynamic assessment PROCEDURE

Part 1: OAB subjects; Part 2: Healthy subjects; Part 2: OAB subjects

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Europe Ltd.: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6202, Netherlands

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Study Manager

  Astellas Pharma Europe Ltd.

  STUDY CHAIR

• Principal Investigator

  Maastricht University Medical Center, Maastricht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 29, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

NL (1)