Bacterial Genomic Sequencing in Overactive Bladder
|ClinicalTrials.gov Identifier: NCT01642277|
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : December 7, 2015
Last Update Posted : December 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Drug: Solifenacin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||August 2014|
Experimental: Women using Solifenacin for OAB treatment
Solifenacin treated women: Women with OAB who are prescribed solifenacin
5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks
Other Name: Vesicare
No Intervention: Control: Women without OAB
Women without OAB who are not prescribed solifenacin.
- Bacterial Genomic Sequencing [ Time Frame: 12 weeks ]Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline.
- Assessment of Overactive Bladder Questionnaire (OABQ) [ Time Frame: End of study (Week 12) ]The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument comprises 33 items. Response options for the symptom frequency and HRQL items are presented as 6-point Likert scales ranging from 'none of the time' to 'all of the time' for symptom frequency (and 'not at all' to 'a very great deal' for symptom bother). From these 33 items, six sub-scales are assessed separately: (1) OAB symptom severity, (2) Coping with OAB symptoms, (3) Concern for OAB symptoms, (4) Sleep as a function of OAB symptoms, (5) Social functioning as a consequence of OAB symptoms, and (6) Health related quality of life (HRQL) as a function of OAB symptoms. Each sub-scale score ranges from 0 to 100 (where higher scores indicate more severe OAB symptoms and lower scores indicate minimal symptom severity).
- Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire [ Time Frame: 12 weeks ]The PFDI comprises 46 items on a 4-point symptom severity scale ranging from 1 = "Not at all" to 4 = "Quite a bit". From these items, 13 separate sub-scales are reported: (1) Obstructive discomfort, (2) Irritation, (3) Stress resulting from urinal distress, (4) A general sub-scale for pelvic organ prolapse distress, (5) An anterior sub-scale for pelvic organ prolapse distress, (6) A posterior sub-scale for pelvic organ prolapse distress, (7) An obstructive sub-scale for colorectal anal distress, (8) Incontinence, (9) Pain, and (10) A rectal prolapse sub-scale for colorectal anal distress. For each of these sub-scales, scores from from 0 to 100 (where higher scores indicate greater symptom severity). There are three additional sub-scales: (11) The urinary distress inventory, (12) The pelvic organ distress inventory, and (13) The colorectal distress inventory. Each of these ranges from 0 to 400 (with higher scores indicating greater symptom severity).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642277
|United States, Illinois|
|Loyola University Chicago Health Sciences Division|
|Maywood, Illinois, United States, 60153|
|Principal Investigator:||Alan J Wolffe, PhD||Loyola University Chicago|