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

NCT ID: NCT01540786

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-06-30

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.

Conditions

Healthy Subjects; Overactive Bladder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Part 1: OAB subjects

Group Type: EXPERIMENTAL

High resolution urodynamic assessment

Intervention Type: PROCEDURE

Conventional urodynamic assessment

Intervention Type: PROCEDURE

Part 2: Healthy subjects

Group Type: EXPERIMENTAL

High resolution urodynamic assessment

Intervention Type: PROCEDURE

Conventional urodynamic assessment

Intervention Type: PROCEDURE

Part 2: OAB subjects

Group Type: EXPERIMENTAL

High resolution urodynamic assessment

Intervention Type: PROCEDURE

Conventional urodynamic assessment

Intervention Type: PROCEDURE

Interventions

High resolution urodynamic assessment

Intervention Type: PROCEDURE

Conventional urodynamic assessment

Intervention Type: PROCEDURE

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

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Europe Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Study Manager

Role: STUDY_CHAIR

Astellas Pharma Europe Ltd.

Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center, Maastricht

Locations

Maastricht University Medical Center

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

905-EC-010

Identifier Type: -

Identifier Source: org_study_id