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1 F305: Urodynamic Studies, version 03/29/06 (A) TOMUS Section A: General Study Information for Office Use Only: A1. Study ID#: Label A2. Visit # Baseline... TBAS F/U 12 Month... TF12 Failure... TFAI Other: VISIT Frequency Percent Frequency Percent 1... TBAS TF SECTIO B: UROFLOWMETRY B1. Maximum flow rate:. ml/sec B2. Mean flow rate:. ml/sec Analysis Variable : max_fl_nif Analysis Variable : mean_fl_nif B3. Time to maximum flow. sec B4. Voided Volume: ml Analysis Variable : flow_t_nif Page 1 of

2 Analysis Variable : void_vol_nif B5. PVR: ml B6. Classify flow pattern: Continuous, smooth... 1 Continuous, fluctuating... 2 Intermittent... 3 Analysis Variable : pvr_nif pattern_nif Frequency Percent Frequency Percent Frequency Missing = 85 B7. IF test date: / / B8. Tester ID: Month Day Year Analysis Variable : nif_comp_days B9. IF Review Date: / / B10. MD Reviewer ID: Month Day Year Page 2 of

3 Analysis Variable : nif_abst_days B11.Equipment BCC Registration ID#: / SECTIO C: URETHRAL PRESSURE PROFILE MUCP data points from one or more of the three withdrawals may be invalid for technical reasons. Please review the MUCP signals and determine if any valid data can be recorded below. C1. Are all MUCP data points valid? Yes, all MUCP data points are valid...1 SKIP TO C2 o, some (or all) MUCP data points are invalid...2 valid_mucp Frequency Percent Frequency Percent C1a. Describe: Measure MUCP Functional Urethral length C2. 1 st withdrawal: cm H 2 O C3. mm Analysis Variable : mucpwi Analysis Variable : mucpli C4. 2 nd withdrawal: cm H 2 O C5. mm Page 3 of

4 Analysis Variable : mucpw Analysis Variable : mucpl C6. 3 rd withdrawal: cm H 2 O C7. mm Analysis Variable : mucpw Analysis Variable : mucpl mucp_2valid Frequency Percent Frequency Percent Y FUL_2valid Frequency Percent Frequency Percent Y Page 4 of

5 SECTIO D: CMG VALIDITY, PRESSURES VOLUMES AD SESATIO MEASUREMETS Affix ID Label CMG pressure measurements will be considered invalid for several reasons; most are listed below. You may also determine CMG pressure values invalid for other reasons. Please review the CMG and code yes or no to each of the following questions, then follow the skip directives to complete your review. D1. Are the signals legible?... Yes (1) o (2)* LEGIBLE_SIG Frequency Percent Frequency Percent MI:O : Yes : o D2. Were the catheters zeroed to atmosphere prior to the start of filling? Yes (1) o (2)* CATH_ATMOS Frequency Percent Frequency Percent MI:O : Yes : o D3. Was the Pves measuring system functioning properly at CMG baseline? Yes (1) o (2)* PVES_CMG_BL Frequency Percent Frequency Percent MI:O : Yes : o Page 5 of

6 D4. Was the Pabd measuring system functioning properly at CMG baseline? Yes (1) o (2)* PABD_CMG_BL Frequency Percent Frequency Percent MI:O : Yes : o D5. Are there any other reasons you consider the CMG invalid? Yes (1)* o (2) REAS_CMG_IV Frequency Percent Frequency Percent MI:O : Yes : o D5a. If Yes, describe D6. WERE THERE AY IVALID CODITIOS FOR THE CMG? [Code D6 Yes (1) if you circled a code in any gray box above.] Yes IF YES, write invalid in the data fields for all CMG pressure values but record values for all other data points. o... 2 cmg_any_invl Frequency Percent Frequency Percent CMG MEASUREMETS D7. Pves at baseline: cm H 2 O Page 6 of

7 Analysis Variable : pves_base_cmg D8. Pabd at baseline: cm H 2 O Analysis Variable : pabd_base_cmg D9. Pdet at baseline: cm H 2 O Analysis Variable : pdet_base_cmg D10. Bladder volume at first desire to void: ml Analysis Variable : first_desire D11. Bladder volume at strong desire to void: ml Analysis Variable : strong_desire Page 7 of

8 LPP MEASURES D12. Did leakage occur with Valsalva? Yes *... 1 o... 2 SKIP TO D14 leak_val Frequency Percent Frequency Percent * To code this item YES, leakage must occur with Valsalva at least twice at the same volume level. D13. At what volume? ml Analysis Variable : volume_lpp D13a. Raw Pves at 1 st leakage: cm H 2 O Analysis Variable : lpp_leak1 Miss Mean Quartile Median Quartile Maximum D13b. Raw Pves at 2 nd leakage: cm H 2 O Page 8 of

9 Analysis Variable : lpp_leak2 Miss Mean Quartile Median Quartile Maximum D13c. Raw Pves at 3 rd leakage: cm H 2 O Analysis Variable : lpp_leak3 Miss Mean Quartile Median Quartile Maximum MCC D14. Did leakage occur with cough at MCC? Yes... 1 o... 2 A, VLPPs obtained at or prior to MCC... 3 leak_mcc Frequency Percent Frequency Percent Page 9 of

10 D15. Bladder volume at MCC: ml Analysis Variable : vol_mcc D15a. Pves at MCC: cm H 2 O Analysis Variable : mcc_pves D15b. Pabd at MCC: cm H 2 O Analysis Variable : mcc_pabd D15a-D15b:mcc_pves - mcc_pabd: Analysis Variable : mcc_pdet DETRUSOR OVERACTIVITY D16. Was there detrusor overactivity? Yes... 1 o... 2 SKIP TO SECTIO E detrusor Frequency Percent Frequency Percent Frequency Missing = 9 Page 10 of

11 Record volume at each occurrence of detrusor overactivity and indicate if leakage occurred. Occurrence Recorded Volume Leakage? D16a. Occurrence 1: ml Yes...1 o...2 Analysis Variable : detrusor_ detrusor_leak_1 Frequency Percent Frequency Percent requency Missing = 981 D16b. Occurrence 2: ml Yes...1 o...2 Analysis Variable : detrusor_ detrusor_leak_2 Frequency Percent Frequency Percent requency Missing = 1022 D16c. Occurrence 3: ml Yes... 1 o... 2 Page 11 of

12 Analysis Variable : detrusor_ detrusor_leak_3 Frequency Percent Frequency Percent requency Missing = 1051 SECTIO E: PRESSURE FLOW STUDY (PFS) PFS pressure measurements will be considered invalid for several reasons; most are listed below. You may also determine PFS pressure values invalid for other reasons. Please review the PFS signals and code yes or no to each of the following questions then follow the skip directives to complete your review. E1. Are the signals legible?... Yes (1) o (2)* PFS_LEG_SIG Frequency Percent Frequency Percent MI:O : Yes : o E2. Were the catheters zeroed to atmosphere prior to the start of filling? Yes (1) o (2)* PFS_CAT_ATM Frequency Percent Frequency Percent MI:O : Yes : o E3. Did the patient sit to void? Yes (1) o (2)* Page 12 of

13 PFS_SIT_VD Frequency Percent Frequency Percent MI:O : Yes : o E4. Were transducers adjusted after the patient changed her position? Yes (1) o (2)* PFS_TR_ADJ Frequency Percent Frequency Percent MI:O : Yes : o E5. Was the PFS baseline interpretable?... Yes (1) o (2)* PFS_BL_ITP Frequency Percent Frequency Percent MI:O : Yes : o E6. Was the Pves measuring system functioning properly at baseline? Yes (1) o (2)* PVES_FU_BL Frequency Percent Frequency Percent MI:O : Yes : o E7. Was the Pabd measuring system functioning properly at baseline? Yes (1) o (2)* Page 13 of

14 PABD_FU_BL Frequency Percent Frequency Percent MI:O : Yes : o E8. Did the patient void?... Yes (1) o (2)* PT_VOID Frequency Percent Frequency Percent MI:O : Yes : o E9. Was the Pves measuring system functioning properly at Qmax? Yes (1) o (2)* PVES_FU_MAX Frequency Percent Frequency Percent MI:O : Yes : o E10. Was the Pabd measuring system functioning properly at Qmax? Yes (1) o (2)* PABD_FU_MAX Frequency Percent Frequency Percent MI:O : Yes : o E11. Are there any other reasons you consider the PFS invalid?... Yes (1)* o (2) Page 14 of

15 REAS_PFS_IV Frequency Percent Frequency Percent MI:O : Yes : o E11a. If Yes, describe E12. WERE THERE AY IVALID CODITIOS FOR THE PFS? [Code E12 Yes if you circled a code in any gray box ] Yes If YES, skip to E18, complete E18 through E, then skip to E25. o... 2 pfs_any_invl Frequency Percent Frequency Percent E13. Was the patient refilled for this PFS? Yes o... 2 refill_pfs Frequency Percent Frequency Percent Frequency Missing = 246 E14. Did the patient cough before the void? Yes o... 2 IF O, SKIP TO E16 cough_vd_pfs Frequency Percent Frequency Percent Page 15 of

16 Frequency Missing = 246 E15. Was there 70% concordance between the Pves and Pabd pre-void cough spike? Yes... 1 o... 2 pves_pabd_cn Frequency Percent Frequency Percent Frequency Missing = 269 Page 16 of

17 E16. PFS BASELIE PRESSURES: Read baseline pressure values after patient sits to void, adjustment of transducers and pre-void cough. Take readings from a stable, flat Pves and Pabd signal. Typically, this measurement occurs a few or several seconds before flow and prior to any vesical or abdominal pressure increase associated with the beginning of the void. E16a. Pves at PFS baseline: cm H 2 O Analysis Variable : pfs_pves_bl E16b. Pabd at PFS baseline: cm H 2 O Analysis Variable : pfs_pabd_bl E16c. Pdet at PFS baseline: cm H 2 O Analysis Variable : pfs_pdet_bl E17. PRESSURES AT MAX FLOW (Qmax) E17a. Pves at Qmax: cm H 2 O E17b. Pabd at Qmax: cm H 2 O Analysis Variable : pves_qmax Page 17 of

18 Analysis Variable : pabd_qmax E17a-E17b:pdet at Qmax Analysis Variable : pdet_qmax E18. Max flow rate:. ml/sec Analysis Variable : max_fl_pfs If the patient cannot void [E8=2 (o)], write missing or -9 for E18-E and skip to E E19. Time to max flow:. sec Analysis Variable : flow_t_pfs E. Voided volume: ml Analysis Variable : void_vol_pfs Skip E21 E24 if the study is invalid per your Yes code to E12. E21. PFS Voiding pattern: Pure or predominant detrusor... 1 Pure or predominant abdominal... 2 Mixed... 3 Page 18 of

19 Indeterminate / uninterpretable... 4 void_mech Frequency Percent Frequency Percent Frequency Missing = 247 E22. Did the patient cough after the void? Yes... 1 o... 2 SKIP TO E25 cghpstvd_pfs Frequency Percent Frequency Percent Frequency Missing = 246 E23. Was the Pves signal functioning during the post void cough? Yes... 1 o... 2 pstcgh_pves Frequency Percent Frequency Percent Frequency Missing = 303 E24. Was the Pabd signal functioning during the post void cough? Yes... 1 o... 2 pstcgh_pabd Frequency Percent Frequency Percent Page 19 of

20 Frequency Missing = 290 E25. UPP/CMG test date: / / E26. Tester ID: Month Day Year Analysis Variable : cmg_comp_days E27. PFS test date: / / E28. Tester ID: Month Day Year Analysis Variable : pfs_comp_days E29. Review date: / / E30. MD Reviewer ID: Month Day Year Analysis Variable : uds_rvw_days E31. Equipment BCC Registration ID#: / Page of

t ( m m : s s. d MEDICA URODYNAMIC REPORTS FD vlpp ND SD vlpp MCC 5 375 25 125 2 7.2 15 1 5 25 13-13 2 4. 15 1 5 2. 15 1 5 VLMa 88.9 89.8 99.6 12.1 28. 219.7 5.2 3.5 4. 11.4 1.1 p1 ves ml cmh2o 3.3 2.6.9.9

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