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 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.
|Healthy Subjects Overactive Bladder||Procedure: High resolution urodynamic assessment Procedure: Conventional urodynamic assessment||Phase 1|
|Study Design:||Allocation: Non-Randomized
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|
- 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) ]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.
- Identify NVA in healthy and OAB subjects using conventional urodynamic assessment [ Time Frame: 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 [ Time Frame: During High resolution and conventional urodynamic assessments (Day 1) ]
- Assess the correlation between NVA and subjects bladder sensations [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: During High resolution and conventional urodynamic assessments (Day 1) ]
|Study Start Date:||March 2012|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540786
|Maastricht University Medical Center|
|Maastricht, Netherlands, 6202|
|Study Chair:||Clinical Study Manager||Astellas Pharma Europe Ltd.|
|Principal Investigator:||Principal Investigator||Maastricht University Medical Center, Maastricht|