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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women using Solifenacin for OAB treatment | Experimental | Solifenacin treated women: Women with OAB who are prescribed solifenacin |
|
| Control: Women without OAB | No Intervention | Women without OAB who are not prescribed solifenacin. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin | Drug | 5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial Genomic Sequencing | Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Overactive Bladder Questionnaire (OABQ) | 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). |
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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:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan J Wolffe, PhD | Loyola University Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Chicago Health Sciences Division | Maywood | Illinois | 60153 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19941278 | Background | Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798. | |
| 19947666 |
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This was a 12-week open label study with no randomization scheme. Following diagnosis, patients were administered 5 mg daily solifenacin. At the 4-week visit, if a participant's symptoms were adequately controlled (response), she continued at dose for the study duration. If a participant reported no improvement, the dose was increased to 10 mg.
Recruitment began on July 16th, 2012 and ended on May 22nd, 2014 (i.e., 22.2 months). Participants were recruited during their outpatient appointments to the Urogynecology Clinic at Loyola University Medical Center (Maywood, IL) by a member of the research team.
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| ID | Title | Description |
|---|---|---|
| FG000 | Urinary Urge Incontinence | Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI). |
| FG001 | Non-Urinary Urge Incontinence | Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analyses includes the baseline information of individuals lacking primary outcome measurements (i.e., patients that withdrew for any reason n = 24).
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| ID | Title | Description |
|---|---|---|
| BG000 | Urinary Urge Incontinence | Seventy-four (n = 74) women received 5mg daily solifenacin (with an option to increase to 10mg daily solifenacin at 4 weeks) for the treatment of urinary urge incontinence (UUI). |
| BG001 | Non-Urinary Urge Incontinence |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bacterial Genomic Sequencing | Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline. | This was a completer analysis comprising participants who completed 12 weeks of treatment (n = 50). | Posted | Number | participants | 12 weeks |
|
|
Participants who received solifenacin were assessed for adverse events over 12 weeks. Control participants who did not receive solifenacin, however, were only seen at baseline (0 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Urinary Urge Incontinence | Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alan J. Wolfe | Loyola University Chicago, Microbiology and Immunology | 224-392-4002 | awolfe@luc.edu |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| End of study (Week 12) |
| Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire | 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). | 12 weeks |
| Background |
| Hartmann KE, McPheeters ML, Biller DH, Ward RM, McKoy JN, Jerome RN, Micucci SR, Meints L, Fisher JA, Scott TA, Slaughter JC, Blume JD. Treatment of overactive bladder in women. Evid Rep Technol Assess (Full Rep). 2009 Aug;(187):1-120, v. |
| 21231991 | Background | Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011 Oct;108(7):1132-8. doi: 10.1111/j.1464-410X.2010.09993.x. Epub 2011 Jan 13. |
| 20025017 | Background | de Boer TA, Salvatore S, Cardozo L, Chapple C, Kelleher C, van Kerrebroeck P, Kirby MG, Koelbl H, Espuna-Pons M, Milsom I, Tubaro A, Wagg A, Vierhout ME. Pelvic organ prolapse and overactive bladder. Neurourol Urodyn. 2010;29(1):30-9. doi: 10.1002/nau.20858. |
| 20803179 | Background | Sajadi KP, Vasavada SP. Overactive bladder after sling surgery. Curr Urol Rep. 2010 Nov;11(6):366-71. doi: 10.1007/s11934-010-0136-2. |
| 12493346 | Background | Mostwin JL. Pathophysiology: the varieties of bladder overactivity. Urology. 2002 Nov;60(5 Suppl 1):22-6; discussion 27. doi: 10.1016/s0090-4295(02)01788-0. |
| 19588154 | Background | Michel MC, Chapple CR. Basic mechanisms of urgency: roles and benefits of pharmacotherapy. World J Urol. 2009 Dec;27(6):705-9. doi: 10.1007/s00345-009-0446-5. |
| 20134114 | Background | Ohtake A, Sato S, Sasamata M, Miyata K. The forefront for novel therapeutic agents based on the pathophysiology of lower urinary tract dysfunction: ameliorative effect of solifenacin succinate (Vesicare), a bladder-selective antimuscarinic agent, on overactive bladder symptoms, especially urgency episodes. J Pharmacol Sci. 2010;112(2):135-41. doi: 10.1254/jphs.09r13fm. Epub 2010 Feb 4. |
| 19331596 | Background | Hoffstetter S, Leong FC. Solifenacin succinate for the treatment of overactive bladder. Expert Opin Drug Metab Toxicol. 2009 Mar;5(3):345-50. doi: 10.1517/17425250902762866. |
| 18654073 | Background | Pelman RS, Capo JP Jr, Forero-Schwanhaeuser S. Solifenacin at 3 years: a review of efficacy and safety. Postgrad Med. 2008 Jul;120(2):85-91. doi: 10.3810/pgm.2008.07.1795. |
| 15716204 | Background | Haab F, Cardozo L, Chapple C, Ridder AM; Solifenacin Study Group. Long-term open-label solifenacin treatment associated with persistence with therapy in patients with overactive bladder syndrome. Eur Urol. 2005 Mar;47(3):376-84. doi: 10.1016/j.eururo.2004.11.004. Epub 2005 Jan 5. |
| 20431184 | Background | Santos JC, Telo ER. Solifenacin: scientific evidence in the treatment of overactive bladder. Arch Esp Urol. 2010 Apr;63(3):197-213. English, Spanish. |
| 15765062 | Background | Oliver JD. The viable but nonculturable state in bacteria. J Microbiol. 2005 Feb;43 Spec No:93-100. |
| 22278835 | Background | Wolfe AJ, Toh E, Shibata N, Rong R, Kenton K, Fitzgerald M, Mueller ER, Schreckenberger P, Dong Q, Nelson DE, Brubaker L. Evidence of uncultivated bacteria in the adult female bladder. J Clin Microbiol. 2012 Apr;50(4):1376-83. doi: 10.1128/JCM.05852-11. Epub 2012 Jan 25. |
| 26423260 | Derived | Thomas-White KJ, Hilt EE, Fok C, Pearce MM, Mueller ER, Kliethermes S, Jacobs K, Zilliox MJ, Brincat C, Price TK, Kuffel G, Schreckenberger P, Gai X, Brubaker L, Wolfe AJ. Incontinence medication response relates to the female urinary microbiota. Int Urogynecol J. 2016 May;27(5):723-33. doi: 10.1007/s00192-015-2847-x. Epub 2015 Sep 30. |
| 25006228 | Derived | Pearce MM, Hilt EE, Rosenfeld AB, Zilliox MJ, Thomas-White K, Fok C, Kliethermes S, Schreckenberger PC, Brubaker L, Gai X, Wolfe AJ. The female urinary microbiome: a comparison of women with and without urgency urinary incontinence. mBio. 2014 Jul 8;5(4):e01283-14. doi: 10.1128/mBio.01283-14. |
| 24371246 | Derived | Hilt EE, McKinley K, Pearce MM, Rosenfeld AB, Zilliox MJ, Mueller ER, Brubaker L, Gai X, Wolfe AJ, Schreckenberger PC. Urine is not sterile: use of enhanced urine culture techniques to detect resident bacterial flora in the adult female bladder. J Clin Microbiol. 2014 Mar;52(3):871-6. doi: 10.1128/JCM.02876-13. Epub 2013 Dec 26. |
| Protocol Violation |
|
| Withdrawal by Subject |
|
Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Median | Standard Deviation | kg/m2 |
|
| Vaginal Parity | Median | Inter-Quartile Range | Births |
|
| Estrogen Status | Number | participants |
|
| Diabetes | Number | participants |
|
| Hypertension | Number | participants |
|
| Coronary Artery Disease | Number | participants |
|
| Smoking | Number | participants |
|
| Marital Status | Number | participants |
|
| Prior Treatment for OAB | Number | participants |
|
| Sequencing Urotypes at Baseline | Number | participants |
|
|
| Secondary | Assessment of Overactive Bladder Questionnaire (OABQ) | 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). | Participants who received solifenacin were asked to complete the OABQ at 12 weeks in order to assess overactive bladder symptoms. | Posted | Median | Inter-Quartile Range | units on a scale | End of study (Week 12) |
|
|
|
|
| Secondary | Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire | 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). | Participants who received solifenacin were asked to complete the PFDI questionnaire at 12 weeks in order to assess certain bowel, bladder, and pelvic symptoms. | Posted | Median | Inter-Quartile Range | units on a scale | 12 weeks |
|
|
|
|
| 0 |
| 74 |
| 10 |
| 74 |
| EG001 | Non-Urinary Urge Incontinence | Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin). | 0 | 0 | 0 | 0 |
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Elevated Blood Pressure | General disorders | Non-systematic Assessment |
|
| Hives | Immune system disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Concern Score |
|
| Sleep Score |
|
| Social Score |
|
| Health Related Quality of Life (HRQL) |
|
| For coping score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of coping scores. The null hypothesis is that there is no difference between the two groups in coping, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) coping than the other group. | Wilcoxon (Mann-Whitney) | .04 | Standardized test statistic (z-score) | 2.06 | 2-Sided | No | Superiority or Other |
| For the concern score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outlier of the concern scores. The null hypothesis is that there is no difference between the two groups in their concern, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) concern than the other group. | Wilcoxon (Mann-Whitney) | .03 | Standardized test statistic (z-score) | 2.176 | 2-Sided | No | Superiority or Other |
| For the sleep score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of sleep scores. The null hypothesis is that there is no difference between the two groups in sleep scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) sleep scores than the other group. | Wilcoxon (Mann-Whitney) | .37 | Standardized test statistic (z-score) | 0.90 | 2-Sided | No | Superiority or Other |
| For social score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of social scores. The null hypothesis is that there is no difference between the two groups in social scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) social scores than the other group. | Wilcoxon (Mann-Whitney) | .04 | Standardized test statistic (z-score) | 2.02 | 2-Sided | No | Superiority or Other |
| For the overall health related quality of life (HRQL) score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of HRQL scores. The null hypothesis is that there is no difference between the two groups in health related quality of life, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) health realted quality of life than the other group. | Wilcoxon (Mann-Whitney) | .04 | Standardized test statistic (z-score) | 2.03 | 2-Sided | No | Superiority or Other |
| Stress Score |
|
| Urinary Distress Inventory Score |
|
| General Score |
|
| Anterior Score |
|
| Posterior Score |
|
| Pelvic Organ Prolapse Distress Inventory Score |
|
| Obstructive Score |
|
| Pain Irritation Score |
|
| Rectal Prolapse |
|
| Colo-Rectal-Anal Distress Inventory Score |
|
| Incontinence Score |
|
| For the irritative score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in irritation, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) irritation than the other group. | Wilcoxon (Mann-Whitney) | .07 | Standardized test statistic (z-score) | -1.80 | 2-Sided | No | Superiority or Other |
| For the stress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in stress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) stress than the other group. | Wilcoxon (Mann-Whitney) | .11 | Standardized test statistic (z-score) | -1.59 | 2-Sided | No | Superiority or Other |
| For the urinary distress inventory score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in urinary distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) urinary distress than the other group. | Wilcoxon (Mann-Whitney) | .09 | Standardized test statistic (z-score) | -1.69 | 2-Sided | No | Superiority or Other |
| For the general score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in general pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) general pelvic floor disease severity than the other group. | Wilcoxon (Mann-Whitney) | .09 | Standardized test statistic (z-score) | -1.68 | 2-Sided | No | Superiority or Other |
| For the anterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in anterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) anterior pelvic floor disease severity than the other group. | Wilcoxon (Mann-Whitney) | .82 | Standardized test statistic (z-score) | -0.23 | 2-Sided | No | Superiority or Other |
| For the posterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in posterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) posterior pelvic floor disease severity than the other group. | Wilcoxon (Mann-Whitney) | .06 | Standardized test statistic (z-score) | -1.92 | 2-Sided | No | Superiority or Other |
| For the pelvic organ prolapse distress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in pelvic organ prolapse distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) pelvic organ prolapse distress than the other group. | Wilcoxon (Mann-Whitney) | .07 | Standardized test statistic (z-score) | -1.85 | 2-Sided | No | Superiority or Other |