FEMALEUROLOGY:DlAGNOSlSAND Saturday,27 March,15.15-16.45,Hall
THE QUALITY OF IMPROVEMENTS
EVALUATION G/Blue level OF
LIFE IMPACT AND CLINICAL IN STRESS INCONTINENCE
Demlrkesen O., Q&&.,
Yalcin I., Bump R Lilly Research Laboratones,
789 THE EVALUATION VAGINAL TAPE
The clinical relevance of “cured” versus “improved” stress urinary incontinence (SUI) has been debated in the surgical, behavioural, and pharmacological literature for decades. In an effort to assess the relative impact of cure and improvement on patients, we compared decreases in incontinence episode frequency (IEF) and number of days with no incontinence episodes (dry days) with change and ending scores respectively from a validated patient-completed incontinence-specific quality of life instrument.
MATEBIAL & METHODS: 1913 women with SUI in Africa, Australia, Europe, and North and South America, were enrolled in 4 randomized, controlled 12.week trials comparing duloxetine 80 mgiday and placebo. Subjects completed seven-day urinary diaries before each visit and a validated condition-specific quality of life questionnaire (I-QOL) at each visit. The percent change in IEF from baseline to endpoint and the number of dry days per week at endpoint were computed from the diaries. The clinical impact of improved SUI was assessed by comparing the percent decrease in IEF with changes in I-QOL scores (Table 1). The impact of cure was assessed by comparing the number of dry days with I-QOL scores at endpoint (Table 2).
Salicyl B., Tune B., Alan C., Cetmel B
No. of patients Mean age (year) Mean the follow up (month) Continence StatuS
CONCLUSIONS: The data suggest that women with SUI attach clinical relevance both to reduced incontinence and to increased dryness. Substantial improvement in condition-specific quality-of-life is perceived when incontinence is reduced by 50% or more. Even a single day increase in number of dry days has a noticeable impact on patient’s quality of life with some plateauing of effect when the majority of days in the week are devoid of accidents.
Surnlcal satisfacrlon -
48 51 9( 38.68) I4 7 (7.5-26.9)
31 53 (36-67) 74 (42.98)
Dyspareunia Sexual satlsfact;on+ NCgEitlVtT Positive No difference Paitner satisfaction’ Negative Positive No difference
113.2 115.3 116.7
RESULTS: The patient characteristics and the results of questionnaire in TVT and Burch groups were shown m the table. Sexual satlsfactlon did not change in 34 of47 (73%) patients in the TVT group. Eleven patients (23%) were negatively affected. while in 2 patients (4%) the sexual function was better than pre-op status. In the Burch group there was no change in sexual functmn in 15 of 19 patients (78%); 2 (11%) patients were negatwely and 2 patients (I 1%) were posaively affected compared to pre-op status. There was no slgniiicant relation between type of surgery and sexual satisfaction and partner satlsfactmn and no statistical significant difference between surgical satisfaction and sexual satisfaction (p>O.O5).
Table 2. Endpoint comparisons Dry Days per Week Mean I-QOLScore
MATERIAL & METHODS: Overall 85 patients were included in this study. 54 ofthese were undergone TVT operation due to US1 between October 1999 and August 2001, while ramming 3 1patients had been undergone Butch colposuspension due to US1 between July 1994 and June 1998 Seventy-mne (93%) sexually active patients and theu partners were invited to the hospital by an experienced nurse whom was asked to fill in a questionnaire developed by our depanment which contams 7 questmns. Three questions were about sexual functions evaluating dyspareuma, sexual satisfaction and paliner’s satisfaction, I question was evaluating pain due to surgery and 3 questions were evaluating surgical satisfactmn The cure was defined as no loss of urine and urinay leakage that occurred once a day or less frequently was regarded as improvement. The cure and nnprovement were both accepted as success. Surgical fadures have been excluded while comparmg the results for sexual satisfacnon The results were compared by using Chi Square and Fisher’s Exact tests.
110% 120% 130% 140% 150% 160% 170% 180% 190% 1100% Increase
INTRODUCTION & OBJECTIVES: In this study we evaluated the sexual function of the female parxnts whom tension free vagmal tape (TVT) were performed with tbe diagnosis of urodynamlc stress incontmence (USI) and the sexual function was compared wth the results obtained by Burch colposuspension.
RESULTS: Inflection points for increases in I-QOL were observed at the 50% and 80% IEF reduction levels (Table 1). The 4.2 point difference between the 40% and the 50% IEF reduction level exceeds the minimum clinically important difference established for I-QOL. There was a steady increase in I-QOL scores with an increasing number of dly days per week (Table 2). I-QOL scores were highest when subjects were dry every day and similarly high when subjects were dry most days of the week (4 or more). Table 1. Change comparisons
Cerrahpasa School of Medicine, Istanbul University, Department of Urology, Istanbul. Turkey
11 (23%) 2 (4%) 34 (73%)
2 (9%) 1 (5%) 19 (86%)
1 (2%) 2 (4%) 44 (94%)
‘Ill S”CCeSS group *Fisher’s exact, **Chl-square CONCLUSIONS: As a conclusion, this study showed that the type of incontmence surgery did not have stat~stlcally slgmficant effect on sexual satisfaction and partner satisfaction.
790 THE CHANGE TENSION-FREE Lee. KS.,
OF OVERACTIVE VAGINAL TAPE
Choe J.H., Cho J.
MATERIAL & METHODS: 254 women who received a TVT for SUI confirmed by history, physical examination and urodynamic study (UDS) were identified from database during 2002 to 2003. Patients underwent TVT surgery by a single surgeon. Patients with neuropathic bladder, urethral diverticulum, urinary tract infection. neoplasm were excluded. Of all 68 patients (27%) had OAB. Finally, 41 women (mean age 55 years) who were followed for over 3 months postoperatively, were evaluated. A total of 29 patients (71%) had urge incontinence and 15 (37%) in these patients had detrusor overactivity (DO) on UDS. There were no differences in clinical characteristics between patients with DO and those without DO. The protocol used for pre- and postoperative evaluation included 3-day frequency/volume chart, urological questionnaire for OAB and QoL evaluation. A criterion for cure of SUI was no leakage at stress test and for OAB symptoms was resolution of OAB symptoms. RESULTS: The overall cure rate was 95% (39141) in SUI, 42% (17/41) in OAB symptoms and 45% (13/29) in urge incontinence at mean follow-up duration of 8.5 months. The mean number of voids in 24 hours were decreased by 27% (from 11.9 i 3.8 to 8.7 + 2.7, p
TVT surgery can be used in stress urinary incontinence with OAB symptoms including Urge incontinence. The operation can preferably be performed if the patient has no DO urodynamically because women with DO correlated with lesser cure rate of OAB symptoms and lower satisfaction. In patients with DO, a proper counsel is recommended preoperatively.
OF AN INCONTINENCE QUESTIONNAIRE
Yalcin I., Peng G., Koke S., Hooper C., Bump R.
Overactive bladder (OAB) symptoms especially urinary urgency and urge incontinence remain difficult to treat as independent entities and as co-factors in patients with stress urinary incontinence (SUI). The data for the efficacy and prognosis of the tension-free vaginal tape (TVT) in these patients is not enough. We assessed the change of the OAB symptoms after TVT in female SUI patients combined by OAB.
791 VALIDATION SATISFACTION
No. 2, pp. 200
Lilly Research Laboratories,
INTRODUCTION & OBJECTIVES: Assess the construct validity of a 4-&m, selfadministered, Patlent Satisfaction Questionnaire (PSQ-4) using data from clinical studies of women with stress urinary incontinence (SUI) treated with duloxetine. MATERIAL & METHODS: 1635 women in Europe, North and South America, Australia, and Africa with SUI of at least 3 months duration were enrolled in 3 large double-blind phase 3 trials of duloxetine versus placebo. Each trial had an open-label extension. The PSQ-4 items rated the patient’s impression of control of the problem, her satisfaction with drug treatment, and her willingness to continue the drug and to recommend the drug to another (each on a 7-p&t Likert scale). A validated questionnaire rating treatment outcome (Patient Global Impression of Improvement, PGI-I) and a validated condition-specific quality of life questionnaire (I-QOL) were administered along with the new questionnaire. In addition, incontinence episode frequency (IEF) was calculated from diaries. Construct validity of each PSQ-4 question was assessed by correlating its endpoint to percent change in IEF, change in I-QOL and endpoint PGI-I (Spearman’s correlations). The treatment differences were analyzed by the Cochran-Mantel-Haenszel statistic. RESULTS: Each PSQ-4 question was significantly correlated with the other outcome measures (see table; all p<.OOOl). There were significant treatment differences in the distribution of responses favouring duloxetine for 3 of the 4 questions (“control of the problem”; “satisfaction with drug treatment”, and “recommend drug to another”), confirming the overall favourable impressions of the drug. Overall, 61%, 58%, 63% and 71% of duloxetine subjects had a favourable response to the PSQ-4 questions. This is consistent with the observation that 65% of the duloxetine-treated subjects rated their condition as better on the PGI-I instmment. There was not a significant treatment difference in the distribution of responses for the “willing to continue present drug” question. However, most subjects in both treatment groups said they would want to continue treatment, all were aware of the open-label extensions, and over 90% of subjects did enter these extensions. PSQ-4 Question Control of problem Satisfaction WI treatment Willing to continue Recommend to another
% Change in IEF .52
Change in I-QOL -.39
.53 .28 .40
-.40 -.25 -.31
.82 .56 .66
CONCLUSIONS: The construct validity of the PSQ-4 has been established. The PSQ-4 treatment results support the findings of other efficacy analyses for duloxetine in women with stress urinary mcontinence.