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ROLE OF URODYNAMICS ON CLINICAL DECISION-MAKING IN PATIENTS WITH URINARY INCONTINENCE AND VOIDING DYSFUNCTION
486
THE JOURNAL OF UROLOGY®
analysis, we used the prolapse (POPDI) and urinary (UDI) subscales of the PFDI. We used Wilcoxon ranked test and McNemar test for repeated parametric and categorical variables, respectively. RESULTS: Thirty-three women with a mean age of 79 years (65-90) were included in the analysis. The median follow-up was 9 months (3-23 months). Prior to surgery, the median POP-Q stage was 3 (range 2-4). Nearly all (91%) had some incontinence symptoms, and 80% reported symptoms of stress urinary incontinence (SUI). Preoperative urodynamic diagnoses included: urodynamic stress incontinence (USI) 1 ERWK 86, DQG GHWUXVRU RYHUDFWLYLW\ LQFRQWLQHQFH '2, 1 '2, 1 QR 86, RU '2, 1 $V H[SHFWHG in women with advanced prolapse, 30% (N=10) had urinary retention (PVR>100 ml) prior to surgery. Following surgery, 13 % reported SUI, and approximately one third (34%) reported urge incontinence. 6WDQGDUGL]HGSRVWRSHUDWLYHF\VWRPHWURJUDPGLDJQRVHVLQFOXGHG USI and 18% DOI. Urinary retention resolved in eight of 10 women with preoperative urinary retention. No patient had a persistently elevated PVR or symptoms of voiding dysfunction requiring surgical revision of sling beyond 6 weeks. CONCLUSIONS: Concomitant midurethral sling at the time of FROSRFOHLVLVUHVXOWVLQORZUDWHVRIVWUHVVLQFRQWLQHQFHZLWKRXWVLJQL¿FDQW postoperative urinary retention. Source of Funding: None
1420 ROLE OF URODYNAMICS ON CLINICAL DECISION-MAKING IN PATIENTS WITH URINARY INCONTINENCE AND VOIDING DYSFUNCTION Hardeep Phull*, Adonis K Hijaz, Howard S Goldman, Adrian V Hernandez, Tara Frenkl, Courtenay K Moore, Louis Moy, Raymond R Rackley, Sandip Vasavada, Firouz Daneshgari. Cleveland, OH, and Philadelphia, PA. INTRODUCTION AND OBJECTIVE: The role of urodynamic studies (UDS) in the management of urinary incontinence (UI) and voiding dysfunction (VD) remains controversial. We conducted a SURVSHFWLYHVWXG\WRLQYHVWLJDWHKRZ8'6LQÀXHQFHVFOLQLFDOGHFLVLRQ PDNLQJ IRU ZRPHQ ZLWK WKHVH GLVRUGHUV DQG K\SRWKHVL]HG WKDW 8'6 alters physicians’ diagnostic impressions. METHODS: Female patients with VD, UI, or pelvic organ prolapse (POP) were recruited into this IRB-approved study. Subjects with pelvic pain, previously treated stress urinary incontinence (SUI), or disabilities were excluded. After completing the Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7), participants were randomly assigned to physicians and some underwent UDS as part of normal workup. Physicians rendered their clinical GLDJQRVLVWUHDWPHQWSODQDQGOHYHORIFRQ¿GHQFHZLWKWKHLUGHFLVLRQ after: 1) initial physical exam 2) reviewing questionnaires 3) reviewing UDS results. Statistical analysis evaluated changes between these time points, using Wilcoxon Signed-Rank test and McNemar’s test for paired SURSRUWLRQVZLWKS LQGLFDWLQJVLJQL¿FDQWGLIIHUHQFHV RESULTS: Among the 141 patients recruited, median age and parity were 59 and 2.0, respectively. The most common initial diagnoses were mixed urinary incontinence (MUI) (23%), POP (15%), and VD (14%). Patients’ median UDI-6 and IIQ-7 scores were each 10.0. ([SRVXUHWRTXHVWLRQQDLUHVUHVXOWHGLQUH¿QHPHQWRIWKHGLDJQRVLVLQ patients (28%) and treatment plan in 37 patients (26%), which was not VLJQL¿FDQWO\GLIIHUHQW+RZHYHUWKHSK\VLFLDQV¶FRQ¿GHQFHOHYHOLQWKHLU GLDJQRVLVDQGWUHDWPHQWSODQVLJQL¿FDQWO\LPSURYHGIURPDQG 7.9 ± 1.3 after initial exam to 8.5 ± 1.0 and 8.4 ± 1.0 after questionnaires, respectively (both p<0.001). UDS was completed in 76/141 (54%) of WKHSDWLHQWVDQGUHVXOWHGLQFKDQJHVWRWKH¿QDOGLDJQRVLVLQRI the subjects (41%) and treatment plan in 15 patients (20%). There was an overall increase in diagnosis of SUI and VD, but a decrease in diagnosis of MUI (p<0.05). There was also an overall decrease in treatment with sling surgery and anticholinergic medications (p<0.05). 7KHSK\VLFLDQV¶FRQ¿GHQFHOHYHOIXUWKHULPSURYHGWR DQG ± 0.8 (p<0.001). CONCLUSIONS: Validated questionnaires improved the FRQ¿GHQFH RI WKH SK\VLFLDQ LQ WKH FOLQLFDO GLDJQRVLV DQG WUHDWPHQW SODQ$GGLWLRQDOH[SRVXUHWR8'6LPSURYHGFRQ¿GHQFHIXUWKHUDQGDOVR
Vol. 179, No. 4, Supplement, Tuesday, May 20, 2008
changed the diagnoses of SUI, MUI, and VD as well as the treatment plan. Source of Funding: Supported by Cleveland Clinic Clinician Investigator Award to Dr. Daneshgari.
1421 VALIDATION OF THE INCONTINENCE SYMPTOM SEVERITY INDEX: A SELF-ASSESSMENT INSTRUMENT FOR VOIDING SYMPTOM SEVERITY IN WOMEN Christian O Twiss*, Jennifer T Anger, Veronica Triaca, Mayank Patel, Ariana Smith, Ja-Hong Kim, Shlomo Raz, Larissa V Rodriguez. Los Angeles, CA. INTRODUCTION AND OBJECTIVE: Most voiding symptom self-assessment instruments assess symptom bother or effect on quality of life. The Incontinence Symptom Severity (ISS) Index is an 8 item instrument for self-assessment of severity of female urinary storage and voiding symptoms rather than symptom bother or effect on quality of life. We assessed the validity of the ISS for female voiding symptom self-assessment. METHODS: Internal consistency was assessed via itemtotal correlations and Cronbach’s alpha. Concurrent validity against the Urogenital Distress Inventory (UDI) was studied in 191 women with incontinence by correlating similar domains of the ISS and UDI-Short Form (UDI-6) plus two additional items from the UDI-Long Form for nocturia (“UDI7”) and urgency (“UDI8”). Concurrent validity against urinary items of the Pelvic Floor Distress Inventory (PFDI) was similarly studied in 74 women with prolapse. Criterion validity of ISS item 1 was studied by comparing mean post-void residuals (PVRs) amongst the 4 possible response levels. Criterion validity of ISS items 5,6,7, and 8 were similarly studied by comparing mean daily pad use amongst the four possible response levels for each. Response to change was assessed by comparing pre- and post-treatment ISS scores. Correlations were DQDO\]HGYLD6SHDUPDQ¶VUKRDQGFRQWLQXRXVGDWDYLDSDLUHGWWHVWRU one-way ANOVA. 5(68/76 6LJQL¿FDQWLWHPWRWDOFRUUHODWLRQVZHUHVHHQIRU each ISS item (table), and Cronbach’s alpha was 0.69. All ISS items VLJQL¿FDQWO\FRUUHODWHGZLWKVLPLODULWHPVRIWKH8',DQG3)', WDEOH 6LJQL¿FDQWSRVWWUHDWPHQWUHGXFWLRQVZHUHREVHUYHGIRUDOO,66LWHPV (table). Progressively higher PVRs were noted for the 4 response levels RI ,66 LWHP ) ,WHP VKRZHG VLJQL¿FDQWO\ LQFUHDVLQJ PHDQ pad use with each response level (F<0.0001). ISS items 5, 6, and DOVR VKRZHG VLJQL¿FDQWO\ LQFUHDVLQJ WUHQGV LQ PHDQ GDLO\ SDG XVH (F<0.0001, F=0.022, F<0.0001, respectively) amongst the 4 response levels for each. CONCLUSIONS: This study validates the internal consistency, criterion validity, and response to change of the ISS. The ISS Index is suitable for assessing symptom severity and outcomes for treatment of female incontinence and voiding symptoms. †p<0.0001, **p<0.001, *p<0.05 ISS Symptom Item Domain 1 2 3 4 5 6 7 8
Incomplete Emptying Sensation of Urgency Nocturia Daytime Frequency Stress Incontinence Urge Incontinence Leakage with activity Degree of pad use
Correlation Correlation PostItem Total Corresponding Corresponding with UDI with Treatment Correlation UDI Item PFDI Item Item PFDI Item Reduction UDI5
0.70†
19
0.81
0.30†
UDI2 UDI8 UDI7
0.54† 0.53† 0.64†
16 22 21
0.58† 0.72† 0.69†
0.54
†
UDI1
0.50
†
15
0.60
0.61†
UDI3
0.78†
17
0.85†
-2.38†
0.72
†
UDI2 UDI8
0.68† 0.43†
16 22
0.67† 0.49†
-0.82†
0.61†
UDI3
0.55†
17
0.66†
-1.68†
0.60
--
--
--
--
-1.11**
0.39† 0.61†
†
Source of Funding: None
-0.43*
†
-0.88† -0.35† -0.65
THE JOURNAL OF UROLOGY®
analysis, we used the prolapse (POPDI) and urinary (UDI) subscales of the PFDI. We used Wilcoxon ranked test and McNemar test for repeated parametric and categorical variables, respectively. RESULTS: Thirty-three women with a mean age of 79 years (65-90) were included in the analysis. The median follow-up was 9 months (3-23 months). Prior to surgery, the median POP-Q stage was 3 (range 2-4). Nearly all (91%) had some incontinence symptoms, and 80% reported symptoms of stress urinary incontinence (SUI). Preoperative urodynamic diagnoses included: urodynamic stress incontinence (USI) 1 ERWK 86, DQG GHWUXVRU RYHUDFWLYLW\ LQFRQWLQHQFH '2, 1 '2, 1 QR 86, RU '2, 1 $V H[SHFWHG in women with advanced prolapse, 30% (N=10) had urinary retention (PVR>100 ml) prior to surgery. Following surgery, 13 % reported SUI, and approximately one third (34%) reported urge incontinence. 6WDQGDUGL]HGSRVWRSHUDWLYHF\VWRPHWURJUDPGLDJQRVHVLQFOXGHG USI and 18% DOI. Urinary retention resolved in eight of 10 women with preoperative urinary retention. No patient had a persistently elevated PVR or symptoms of voiding dysfunction requiring surgical revision of sling beyond 6 weeks. CONCLUSIONS: Concomitant midurethral sling at the time of FROSRFOHLVLVUHVXOWVLQORZUDWHVRIVWUHVVLQFRQWLQHQFHZLWKRXWVLJQL¿FDQW postoperative urinary retention. Source of Funding: None
1420 ROLE OF URODYNAMICS ON CLINICAL DECISION-MAKING IN PATIENTS WITH URINARY INCONTINENCE AND VOIDING DYSFUNCTION Hardeep Phull*, Adonis K Hijaz, Howard S Goldman, Adrian V Hernandez, Tara Frenkl, Courtenay K Moore, Louis Moy, Raymond R Rackley, Sandip Vasavada, Firouz Daneshgari. Cleveland, OH, and Philadelphia, PA. INTRODUCTION AND OBJECTIVE: The role of urodynamic studies (UDS) in the management of urinary incontinence (UI) and voiding dysfunction (VD) remains controversial. We conducted a SURVSHFWLYHVWXG\WRLQYHVWLJDWHKRZ8'6LQÀXHQFHVFOLQLFDOGHFLVLRQ PDNLQJ IRU ZRPHQ ZLWK WKHVH GLVRUGHUV DQG K\SRWKHVL]HG WKDW 8'6 alters physicians’ diagnostic impressions. METHODS: Female patients with VD, UI, or pelvic organ prolapse (POP) were recruited into this IRB-approved study. Subjects with pelvic pain, previously treated stress urinary incontinence (SUI), or disabilities were excluded. After completing the Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7), participants were randomly assigned to physicians and some underwent UDS as part of normal workup. Physicians rendered their clinical GLDJQRVLVWUHDWPHQWSODQDQGOHYHORIFRQ¿GHQFHZLWKWKHLUGHFLVLRQ after: 1) initial physical exam 2) reviewing questionnaires 3) reviewing UDS results. Statistical analysis evaluated changes between these time points, using Wilcoxon Signed-Rank test and McNemar’s test for paired SURSRUWLRQVZLWKS LQGLFDWLQJVLJQL¿FDQWGLIIHUHQFHV RESULTS: Among the 141 patients recruited, median age and parity were 59 and 2.0, respectively. The most common initial diagnoses were mixed urinary incontinence (MUI) (23%), POP (15%), and VD (14%). Patients’ median UDI-6 and IIQ-7 scores were each 10.0. ([SRVXUHWRTXHVWLRQQDLUHVUHVXOWHGLQUH¿QHPHQWRIWKHGLDJQRVLVLQ patients (28%) and treatment plan in 37 patients (26%), which was not VLJQL¿FDQWO\GLIIHUHQW+RZHYHUWKHSK\VLFLDQV¶FRQ¿GHQFHOHYHOLQWKHLU GLDJQRVLVDQGWUHDWPHQWSODQVLJQL¿FDQWO\LPSURYHGIURPDQG 7.9 ± 1.3 after initial exam to 8.5 ± 1.0 and 8.4 ± 1.0 after questionnaires, respectively (both p<0.001). UDS was completed in 76/141 (54%) of WKHSDWLHQWVDQGUHVXOWHGLQFKDQJHVWRWKH¿QDOGLDJQRVLVLQRI the subjects (41%) and treatment plan in 15 patients (20%). There was an overall increase in diagnosis of SUI and VD, but a decrease in diagnosis of MUI (p<0.05). There was also an overall decrease in treatment with sling surgery and anticholinergic medications (p<0.05). 7KHSK\VLFLDQV¶FRQ¿GHQFHOHYHOIXUWKHULPSURYHGWR DQG ± 0.8 (p<0.001). CONCLUSIONS: Validated questionnaires improved the FRQ¿GHQFH RI WKH SK\VLFLDQ LQ WKH FOLQLFDO GLDJQRVLV DQG WUHDWPHQW SODQ$GGLWLRQDOH[SRVXUHWR8'6LPSURYHGFRQ¿GHQFHIXUWKHUDQGDOVR
Vol. 179, No. 4, Supplement, Tuesday, May 20, 2008
changed the diagnoses of SUI, MUI, and VD as well as the treatment plan. Source of Funding: Supported by Cleveland Clinic Clinician Investigator Award to Dr. Daneshgari.
1421 VALIDATION OF THE INCONTINENCE SYMPTOM SEVERITY INDEX: A SELF-ASSESSMENT INSTRUMENT FOR VOIDING SYMPTOM SEVERITY IN WOMEN Christian O Twiss*, Jennifer T Anger, Veronica Triaca, Mayank Patel, Ariana Smith, Ja-Hong Kim, Shlomo Raz, Larissa V Rodriguez. Los Angeles, CA. INTRODUCTION AND OBJECTIVE: Most voiding symptom self-assessment instruments assess symptom bother or effect on quality of life. The Incontinence Symptom Severity (ISS) Index is an 8 item instrument for self-assessment of severity of female urinary storage and voiding symptoms rather than symptom bother or effect on quality of life. We assessed the validity of the ISS for female voiding symptom self-assessment. METHODS: Internal consistency was assessed via itemtotal correlations and Cronbach’s alpha. Concurrent validity against the Urogenital Distress Inventory (UDI) was studied in 191 women with incontinence by correlating similar domains of the ISS and UDI-Short Form (UDI-6) plus two additional items from the UDI-Long Form for nocturia (“UDI7”) and urgency (“UDI8”). Concurrent validity against urinary items of the Pelvic Floor Distress Inventory (PFDI) was similarly studied in 74 women with prolapse. Criterion validity of ISS item 1 was studied by comparing mean post-void residuals (PVRs) amongst the 4 possible response levels. Criterion validity of ISS items 5,6,7, and 8 were similarly studied by comparing mean daily pad use amongst the four possible response levels for each. Response to change was assessed by comparing pre- and post-treatment ISS scores. Correlations were DQDO\]HGYLD6SHDUPDQ¶VUKRDQGFRQWLQXRXVGDWDYLDSDLUHGWWHVWRU one-way ANOVA. 5(68/76 6LJQL¿FDQWLWHPWRWDOFRUUHODWLRQVZHUHVHHQIRU each ISS item (table), and Cronbach’s alpha was 0.69. All ISS items VLJQL¿FDQWO\FRUUHODWHGZLWKVLPLODULWHPVRIWKH8',DQG3)', WDEOH 6LJQL¿FDQWSRVWWUHDWPHQWUHGXFWLRQVZHUHREVHUYHGIRUDOO,66LWHPV (table). Progressively higher PVRs were noted for the 4 response levels RI ,66 LWHP ) ,WHP VKRZHG VLJQL¿FDQWO\ LQFUHDVLQJ PHDQ pad use with each response level (F<0.0001). ISS items 5, 6, and DOVR VKRZHG VLJQL¿FDQWO\ LQFUHDVLQJ WUHQGV LQ PHDQ GDLO\ SDG XVH (F<0.0001, F=0.022, F<0.0001, respectively) amongst the 4 response levels for each. CONCLUSIONS: This study validates the internal consistency, criterion validity, and response to change of the ISS. The ISS Index is suitable for assessing symptom severity and outcomes for treatment of female incontinence and voiding symptoms. †p<0.0001, **p<0.001, *p<0.05 ISS Symptom Item Domain 1 2 3 4 5 6 7 8
Incomplete Emptying Sensation of Urgency Nocturia Daytime Frequency Stress Incontinence Urge Incontinence Leakage with activity Degree of pad use
Correlation Correlation PostItem Total Corresponding Corresponding with UDI with Treatment Correlation UDI Item PFDI Item Item PFDI Item Reduction UDI5
0.70†
19
0.81
0.30†
UDI2 UDI8 UDI7
0.54† 0.53† 0.64†
16 22 21
0.58† 0.72† 0.69†
0.54
†
UDI1
0.50
†
15
0.60
0.61†
UDI3
0.78†
17
0.85†
-2.38†
0.72
†
UDI2 UDI8
0.68† 0.43†
16 22
0.67† 0.49†
-0.82†
0.61†
UDI3
0.55†
17
0.66†
-1.68†
0.60
--
--
--
--
-1.11**
0.39† 0.61†
†
Source of Funding: None
-0.43*
†
-0.88† -0.35† -0.65