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

This study has been terminated.
(It was decided to discontinue the study due to insufficient recruitment)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier:
NCT01540786
First received: February 13, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Overactive Bladder
Procedure: High resolution urodynamic assessment
Procedure: Conventional urodynamic assessment
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: During High resolution and conventional urodynamic (Day 1) assessments ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Assess the correlation between NVA and subjects bladder sensations [ Time Frame: During High resolution and conventional urodynamic assessments (Day 1) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: February 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540786

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, 6202
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe Ltd.
Principal Investigator: Principal Investigator Maastricht University Medical Center, Maastricht
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier: NCT01540786     History of Changes
Other Study ID Numbers: 905-EC-010
Study First Received: February 13, 2012
Last Updated: March 12, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Astellas Pharma Inc:
OAB
High Resolution Urodynamics

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014