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Completed

NCT Number: NCT01642277

Bacterial Genomic Sequencing in Overactive Bladder

No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection (UTI)causes similar symptoms to OAB with the difference being the presence of bacteria, as evidenced by routine microbiology cultures. Recent work by the group on the genitourinary microbiome (GUM) has shown that female urine, even in the absence of culture evidence of bacteria does have evidence of bacterial DNA. Bacterial 16S rRNA can be isolated from urine and sequenced to identify bacterial species present in urine. From this the investigators can hypothesize that urinary bacteria contribute to urinary symptoms and that there is a difference in the bacterial communities in the urine of women who respond to Solifenacin, a drug used to treat OAB, versus those that do not.

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Key information

About this study

This is a prospective study with two groups: Women who have accepted a clinical recommendation for OAB treatment with solifenacin and a comparator (control) group of women unaffected by OAB. All women will have a baseline urine assessment with bacterial genome sequencing. Solifenacin treated patients will also have urine assessments with bacterial genomic sequencing at 4 and 12 weeks on treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Controls: Women without bother from urinary symptoms will be screened for potential study participation using the pelvic floor distress inventory (PFDI). Women with negative urinary responses will be further screened for participation using the following eligibility criteria:

  • no anticholinergic medications for bladder conditions,
  • no antibiotic exposure in the past 4 weeks for any reason,
  • no immunologic deficiency,
  • no pelvic malignancy or pelvic radiation, and
  • Untreated symptomatic POP > POP-Q Stage II.

OAB cohort: Women with bother from overactive bladder symptoms will be screened for potential study participation using the pelvic floor distress inventory (PFDI). Women with positive urinary responses for urge predominant symptoms will be further screened for participation using the following eligibility criteria:

  • willing to take Solifenacin as treatment for OAB,
  • no neurological disease known to affect the lower urinary tract,
  • no current UTI (based on urine dipstick) or recurrent UTI,
  • no antibiotic exposure in the past 4 weeks for any reason,
  • no immunologic deficiency,
  • no pelvic malignancy or pelvic radiation,
  • untreated symptomatic POP > POP-Q Stage II,
  • no contraindications to receiving Solifenacin.

Exclusion criteria

  • Women who are of child-bearing potential who are pregnant, nursing, intending to become pregnant during the study or not practicing a reliable form of contraception are also excluded.

Treatment and study plan

solifenacin

Drug

5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks

Other names: Vesicare

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Collaborators

  • Astellas Pharma US, Inc.

Registry information

Official study title

The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2012
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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