Analysis of Results From Ongoing Studies

Tatyana Shamliyan; Jean Wyman; Robert L Kane

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Shamliyan T, Wyman J, Kane RL. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Apr. (Comparative Effectiveness Reviews, No. 36.)

This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Appendix CAnalysis of Results From Ongoing Studies

Appendix Table C1Distribution of studies of nonsurgical treatments for UI closed in www.clinicaltrials.gov on May 20, 2010

Categories	Type	Frequency	Percent
Gender	Both	95	57.23
	Female	71	42.77

Age Groups	Adult	15	9.04
	Adult \|Senior	147	88.55
	Child \|Adult \|Senior	4	2.41

Diagnosis	Incontinence	3	1.81
	Overactive Bladder	96	57.83
	Stress Urinary Incontinence	13	7.83
	Urge Incontinence	4	2.41
	Urinary Incontinence	50	30.12

Funding Sources	Industry	122	73.49
	NIH	5	3.01
	NIH/Other	1	0.6
	Other	23	13.86
	Other/Industry	10	6.02
	Other/NIH	1	0.6
	Other/U.S. Fed	1	0.6
	Other\|Unknown/U.S. Fed	1	0.6
	U.S. Fed	2	1.2

Study Types	Interventional	145	87.35
	Observational	21	12.65

Phases of Clinical Trials	Phase I	9	6.57
	Phase II	32	23.36
	Phase III	59	43.07
	Phase II/Phase III	3	2.19
	Phase IV	32	23.36
	Phase I/Phase II	2	1.46

Interventions	Behavioral	8	5.3
	Biological	4	2.65
	Device	10	6.62
	Dietary supplement	1	0.66
	Drug	121	80.13
	Genetic	1	0.66
	Other	4	2.65
	Procedure	2	1.32

Recruitment	Active, not recruiting	26	15.66
	Completed	120	72.29
	Enrolling by invitation	5	3.01
	Terminated	12	7.23
	Withdrawn	3	1.81

Study Results	Has Results	7	4.22
	No Results Available	159	95.78

Publication	No	138	83.13
	Yes	28	16.87

: The numbers may not round to the same sum of 166 studies because of missing information.

Appendix Table C2Posting of results of UI studies by study category in www.clinicaltrial.gov

Categories	Type	Has results	No results available	Total	% with results
Gender	Both	7	88	95	7.4
	Female	0	71	71	0.0

Age	Adult	0	15	15	0.0
	Adult/Senior	7	140	147	4.8
	Child/Adult/Senior	0	4	4	0.0

Diagnosis	Incontinence	0	3	3	0.0
	Overactive Bladder	6	90	96	6.3
	Stress Urinary Incontinence	0	13	13	0.0
	Urge Incontinence	0	4	4	0.0
	Urinary Incontinence	1	49	50	2.0

Sponsorship	Industry	6	116	122	4.9
	NIH	0	5	5	0.0
	NIH/Other	0	1	1	0.0
	Other	0	23	23	0.0
	Other/Industry	0	10	10	0.0
	Other/NIH	1	0	1	100.0
	Other/U.S. Fed	0	1	1	0.0
	Other/Unknown/U.S. Fed	0	1	1	0.0
	U.S. Fed	0	2	2	0.0

Study Type	Interventional	7	138	145	4.8
	Observational	0	21	21	0.0

Phase of Clinical Trials	Phase I	0	9	9	0.0
	Phase I/Phase II	0	2	2	0.0
	Phase II	1	31	32	3.1
	Phase II/Phase III	0	3	3	0.0
	Phase III	4	55	59	6.8
	Phase IV	1	31	32	3.1

Intervention	Behavioral	0	8	8	0.0
	Biological	1	3	4	25.0
	Device	0	10	10	0.0
	Dietary Supplement	0	1	1	0.0
	Drug	5	116	121	4.1
	Genetic	0	1	1	0.0
	Other	1	3	4	25.0
	Procedure	0	2	2	0.0

Recruitment	Active, not recruiting	0	26	26	0.0
	Completed	7	113	120	5.8
	Enrolling by invitation	0	5	5	0.0
	Terminated	0	12	12	0.0
	Withdrawn	0	3	3	0.0

Publication	No	4	134	138	2.9
	Yes	3	25	28	10.7

Appendix Table C3Reporting of results by sponsors of closed studies of UI (sorted by total number of funded studies, shown if more than one study was funded)

Sponsors	Has results	No results available	Total	% with results
Total	7	159	166	4
Pfizer	3	26	29	10
Astellas Pharma, Inc.	0	14	14	0
Eli Lilly and Company/Boehringer Ingelheim Pharmaceuticals	0	12	12	0
GlaxoSmithKline	0	6	6	0
Allergan	1	3	4	25
Alza Corporation, DE, USA	0	4	4	0
Eli Lilly and Company	0	4	4	0
Duramed Research	0	3	3	0
Merck	0	3	3	0
Novartis/Procter and Gamble	0	3	3	0
Ono Pharma	0	3	3	0
Uroplasty, Inc	0	3	3	0
Astellas Pharma Inc./Astellas Pharma Europe BV	0	2	2	0
Astellas Pharma Inc./Astellas Pharma Korea, Inc.	0	2	2	0
Bayer	0	2	2	0
Cleveland Clinic Florida/Astellas Pharma US, Inc.	0	2	2	0
Department of Veterans Affairs	0	2	2	0
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	0	2	2	0
Kissei Pharmaceutical Co., Ltd.	0	2	2	0
Medtronic Neuro	0	2	2	0
Novartis	0	2	2	0
Sanofi-Aventis	0	2	2	0
University of Michigan	0	2	2	0
William Beaumont Hospitals	0	2	2	0
Watson Pharmaceuticals	1	1	2	50

Appendix Table C4Publication of results in peer reviewed journals by categories of studies of UI

Category	Type	Not Published in peer reviewed journals	Published in peer review journals	Total	% published
Gender	Both	80	15	95	16
	Female	58	13	71	18

Age	Adult	14	1	15	7
	Adult/Senior	121	26	147	18
	Child/Adult/Senior	3	1	4	25

Diagnosis	Incontinence	3	0	3	0
	Overactive Bladder	80	16	96	17
	Stress Urinary Incontinence	12	1	13	8
	Urge Incontinence	4	0	4	0
	Urinary Incontinence	39	11	50	22

Sponsorship	Industry	105	17	122	14
	NIH	1	4	5	80
	NIH/Other	1	0	1	0
	Other	18	5	23	22
	Other/Industry	9	1	10	10
	Other/NIH	1	0	1	0
	Other/U.S. Fed	1	0	1	0
	Other/Unknown/U.S. Fed	1	0	1	0
	U.S. Fed	1	1	2	50

Study Type	Interventional	119	26	145	18
	Observational	19	2	21	10

Phase of Clinical Trials	Phase I	9	0	9	0
	Phase I \|Phase II	2	0	2	0
	Phase II	30	2	32	6
	Phase II\| Phase III	1	2	3	67
	Phase III	45	14	59	24
	Phase IV	25	7	32	22

Intervention	Behavioral	4	4	8	50
	Biological	4	0	4	0
	Device	10	0	10	0
	Dietary Supplement	1	0	1	0
	Drug	99	22	121	18
	Genetic	1	0	1	0
	Other	4	0	4	0
	Procedure	2	0	2	0

Recruitment	Active, not recruiting	24	2	26	8
	Completed	95	25	120	21
	Enrolling by invitation	5	0	5	0
	Terminated	12	0	12	0
	Withdrawn	2	1	3	33

Appendix Table C5Publication of results in peer reviewed journals by sponsors of studies of UI (sorted by total number of sponsored studies; shown if more than one study was sponsored)

Sponsors	Not published in peer review journals	Published in peer review journals	Total	% published
	No	Yes
Total	138	28	166	17
Pfizer	25	4	29	14
Astellas Pharma, Inc.	10	4	14	29
Eli Lilly and Company/Boehringer Ingelheim Pharmaceuticals	11	1	12	8
GlaxoSmithKline	6	0	6	0
Allergan	4	0	4	0
Alza Corporation, DE, USA	3	1	4	25
Eli Lilly and Company	3	1	4	25
Duramed Research	3	0	3	0
Merck	3	0	3	0
Novartis/Procter and Gamble	2	1	3	33
Ono Pharma	3	0	3	0
Uroplasty, Inc.	3	0	3	0
Astellas Pharma Inc./Astellas Pharma Europe BV	2	0	2	0
Astellas Pharma Inc./Astellas Pharma Korea, Inc.	1	1	2	50
Bayer	2	0	2	0
Cleveland Clinic Florida/Astellas Pharma US, Inc.	1	1	2	50
Department of Veterans Affairs	1	1	2	50
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	0	2	2	100
Kissei Pharmaceutical Co., Ltd.	2	0	2	0
MedtronicNeuro	2	0	2	0
Novartis	1	1	2	50
Sanofi-Aventis	2	0	2	0
University of Michigan	0	2	2	100
Watson Pharmaceuticals	0	2	2	100
William Beaumont Hospitals	2	0	2	0

Bookshelf ID: NBK92961

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