References for Appendix F

(Note that this set of references is different from those in the text of the report and the numbers are different.)

1.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for Pelvex hometrainer. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K002043.pdf.

2.

U.S. Food and Drug Administration CfDEaR. 510(k) summary for Vitala(tm) continence Control Device. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf8/K083785.pdf.

3.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for uresta Pessary. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf8/K083769.pdf.

4.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for PelvicFlexer. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K011688.pdf.

5.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for Hollister Contimed Pressure Biofeedback device. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K960311.pdf.

6.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary of pathway vaginal emg/stimulation perineometer sensor. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K993976.pdf.

7.

U.S. Food and Drug Administration CfDEaR. 501(k) summary for UroMed Alternative Bladder Control Continence Device. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K971992pdf.

8.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for InCare Pelvic Floor Therapy System with Desktop Computer. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K961872pdf.

9.

U.S. Food and Drug Administration CfDEaR. 510(k) summary review for perineometer and vaginal probe. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K970145.pdf.

10.

U.S. Food and Drug Administration CfDEaR. 510(k) summary for vaginal stimulation/emg probe - tampon. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K971541.pdf.

11.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for innoSense pelvic floor stimulation and electromyography system. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K971527.pdf.

12.

U.S. Food and Drug Administration CfDEaR. 510(k) summary for vaginal stimulation/emg probe - small. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K970602.pdf.

13.

U.S. Food and Drug Administration CfDEaR. 510(k) summary for periform perineometric probe and pelvic floor contraction indicator. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K981277.pdf.

14.

U.S. Food and Drug Administration CfDEaR. 510(k) summary review for peritron perineometer. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K983052.pdf.

15.

U.S. Food and Drug Administration CfDEaR. 510(k) summary for reflex treatment system. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K994079.pdf.

16.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for Mentor EvaCare Vaginal Pessaries. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K993308.pdf.

17.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for PelvX Incontinence Dish. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K990593.pdf.

18.

U.S. Food and Drug Administration CfDEaR. Summary for pelvic muscle therapy. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K002830.pdf.

19.

U.S. Food and Drug Administration CfDEaR. 510(k) summary accuset sensor. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K001386.pdf.

20.

U.S. Food and Drug Administration CfDEaR. 510(k) summary for femiscan clinic system and personal system. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K993411.pdf.

21.

U.S. Food and Drug Administration CfDEaR. Summary Review for InCare Pelvic Floor Therapy System. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K013612.pdf.

22.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for InCare Pressure Biofeedback Vaginal and Anal Pressure Probes. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K013653.pdf.

23.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for MTI ST#1 Silicone Pessary. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf2/K020512.pdf.

24.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for Portex Ring Pessary. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K012277.pdf.

25.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for marina Medical Silicone Pessary. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf3/K031463.pdf.

26.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for Kolpexin Sphere. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf3/K032644.pdf.

27.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for Intra-vaginal stress incontinence device. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf6/K060526.pdf.

28.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for pathway vaginal/rectal perineometer probe. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K974036.pdf.

29.

U.S. Food and Drug Administration CfDEaR. 510(k) summary for anal stimulation/emg probe - w/Stop. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K990456.pdf.

30.

U.S. Food and Drug Administration CfDEaR. 510(k) Summary for InCare Pelvic Floor Therapy System with Desktop Computer. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K961872pdf.

31.

U.S. Food and Drug Administration CfDEaR. 510(k) summary for liberty plus system pfs-300. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/cdrh_docs/pdf/K970077.pdf.

32.

U.S. Food and Drug Administration CfDEaR. Medical Review for Gelnique (oxybutynin chloride) 10% gel. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2009/022204s000_gelnique_toc​.cfm.

33.

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34.

U.S. Food and Drug Administration CfDEaR. Medical Review for PAMELOR (Brand Name Drug). [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2001/018012_s024_PAMELOR​%20CAPSULES.pdf.

35.

U.S. Food and Drug Administration CfDEaR. Medical Review for Sanctura (Trospium Chloride) Tablets. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2004/21-595_Sanctura.cfm.

36.

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37.

Zinner N, Gittelman M, Harris R, et al. Trospium chloride improves overactive bladder symptoms: a multicenter phase III trial. J Urol. 2004 Jun;171(6 Pt 1):2311–5. quiz 435. [PubMed: 15126811]

38.

U.S. Food and Drug Administration CfDEaR. Medical Review for VesiCare (Solifenacin Succinate) Tablets. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2004/21-518_VesiCare.cfm.

39.

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40.

U.S. Food and Drug Administration CfDEaR. Medical Review for Sanctura XR (Trospium Chloride) Extended Release Capsules. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2007/022103s000TOC.cfm.

41.

U.S. Food and Drug Administration CfDEaR. Medical Review for Ditropan XL ( Oxybutinin Chloride) Tablets. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/drugsatfda_docs/nda/98/20897​.cfm.

42.

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43.

U.S. Food and Drug Administration CfDEaR. Medical Review for Enablex (Clarifenacin) Extended Release Tablets. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2004/21-513_Enablex.cfm.

44.

Hill S, Khullar V, Wyndaele JJ, et al. Dose response with darifenacin, a novel once-daily M3 selective receptor antagonist for the treatment of overactive bladder: results of a fixed dose study. Int Urogynecol J Pelvic Floor Dysfunct. 2006 May;17(3):239–47. [PubMed: 15999217]

45.

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46.

U.S. Food and Drug Administration CfDEaR. Statistical Review for Sanctura XR (Trospium Chloride) Extended Release Capsules. [Accessed June 25, 2010]. Available at: http://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2007/022103s000TOC.cfm.

47.

Staskin D, Sand P, Zinner N, et al. Once daily trospium chloride is effective and well tolerated for the treatment of overactive bladder: results from a multicenter phase III trial. J Urol. 2007 Sep;178(3 Pt 1):978–83. discussion 83–4. [PubMed: 17632131]

48.

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50.

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51.

U.S. Food and Drug Administration CfDEaR. Product Monograph for SANCTURA XR. [Accessed June 25, 2010]. Available at: http://webprod​.hc-sc​.gc.ca/dpd-bdpp/dispatch-repartition​.do?lang=eng.

52.

Staskin DR, Rosenberg MT, Sand PK, et al. Trospium chloride once-daily extended release is effective and well tolerated for the treatment of overactive bladder syndrome: an integrated analysis of two randomised, phase III trials. Int J Clin Pract. 2009 Dec;63(12):1715–23. [PubMed: 19930332]

53.

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54.

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55.

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56.

Randomized Trial for Botox Urinary Incontinence. NCT00178191. Available at: http://www​.clinicaltrials​.gov/ct2/show/NCT00178191?term​=NCT00178191&rank=1.

57.

A Study Comparing the Efficacy and Safety of OROS® Oxybutynin to That of Ditropan® (Immediate-release Oxybutynin) for the Treatment of Patients With Urge or Mixed Urinary Incontinence. [Accessed June 25, 2010]. NCT00269750. Available at: http:​//clinicaltrials​.gov/show/NCT00269750.

58.

Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB). NCT00444925. Available at: http://www​.clinicaltrials​.gov/ct2/show/NCT00444925?term​=NCT00444925&rank=1.

59.

Fesoterodine Flexible Dose Study. NCT00536484. Available at: http://www​.clinicaltrials​.gov/ct2/show/NCT00536484?term​=NCT00536484&rank=1.

60.

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61.

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64.

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