Incontinence Impact Questionnaire Short Form Research Articles

What is the success of drug treatment in urge urinary incontinence? What should be measured?

The aim of this study is to evaluate the efficacy and the tolerability of three classic antimuscarinic drugs used in the treatment of over active bladder syndrome using clinical data and quality of life tests, and to evaluate the parameters affecting the success of these drugs. A total of 90 patients with urge urinary incontinence were randomly allocated into three groups either to receive tolterodine (group A), trospium chloride (group B) or oxybutynin (group C). Urogenital distress inventory short form (UDI-6) and Incontinence impact questionnaire short form (IIQ-7) of the Turkish Urogynecology and Pelvic Reconstructive Surgery Association were performed to each patient before and after treatment to evaluate the effectiveness and tolerability of the antimuscarinic drugs. Adverse events were also recorded during treatment. Improved urodynamic test values were recorded after 6 weeks of treatment in each group. Similarly, statistically significant differences were observed in UDI-6 and IIQ-7 test scores before and after treatment. Complete cure was achieved in 86 % of patients in group A; however, complete cure rates were 67 and 80 % in group B and C, respectively. Although, patients reported comparable tolerability against trospium chloride (77 %) and tolterodine (80 %), only 23 % of patients using oxybutynin considered the drug as tolerable. The most common side effect was dry mouth, followed by insomnia. Both dry mouth and insomnia was highest in group C (50 %). One patient (0.3 %) in group B and two patients (0.7 %) in group C reported that they did not want to continue to use the drug. Antimuscarinic medications are very successful in the treatment of urge urinary incontinence; however, the success of treatment is not only limited to clinical improvement. Patients do not regard a drug as successful unless it is tolerable, easy to adapt to the daily life and improve the quality of life even it has very successful clinical outcomes.

Miniarc® single-incision sling for treatment of stress urinary incontinence: 2-year clinical outcomes

We report 2-year data on the effectiveness and safety of the MiniArc single-incision sling in women with stress urinary incontinence. This multi-center, prospective, single-arm, industry-sponsored study measured the effectiveness of the MiniArc sling via quantitative (cough stress test and 1-h pad weight test) and qualitative (Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form) measurements. The objective efficacy rate was defined as the number of patients with a negative cough stress test or 1-h pad weight test ≤ 1 g at 2 years. The subjective efficacy rate was determined by patient responses to the UDI-6 question # 3, "Do you experience, and if so, how much are you bothered by urine leakage related to physical activity, coughing, or sneezing?" Secondary objectives were to evaluate procedural variables of implantation and long-term safety. One hundred and eighty women with a mean age of 51.1 years were implanted in the study. Mean procedure time, blood loss, and length of stay were 11.0 min, 41.7 mL and 9.5 h respectively. At 2 years, 142 patients were available for analysis. The objective efficacy rates for the cough stress test (CST) and pad weight test (PWT) were 84.5 % and 80.1 % respectively and the subjective efficacy rate was 92.9 %. Median Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form scores showed statistically significant improvement (p < .001). The most common adverse events included UTI (4.8 %), constipation (3.7 %), and temporary urinary retention (3.2 %). MiniArc is a safe and effective surgical procedure for the treatment of SUI in women with follow-up through 2 years.

MiniArc Single-Incision Sling in the Office Setting

Study ObjectiveTo report MiniArc single-incision sling efficacy results in the office setting and the feasibility of performing the procedure in the office. DesignProspective, single-arm, nonrandomized, institutional review board–approved study (Canadian Task Force classification II-2). SettingThree in-office clinical sites in the United States. PatientsThirty-eight patients who underwent treatment of stress urinary incontinence using the MiniArc single-incision sling. InterventionA MiniArc single-incision sling was placed in 38 patients in an office-based setting under intravenous or oral sedation and/or local anesthesia. Measurements and Main ResultsThirty-eight implant recipients were evaluated for effectiveness and safety via qualitative (Urinary Distress Inventory–Short Form [UDI-6] and Incontinence Impact Questionnaire–Short Form [IIQ-7]) and quantitative (1-hour pad-weight test and cough stress test) measurements at 3 clinical sites. Secondary outcome measures included procedure time, estimated blood loss, length of stay, perioperative complications, Wong-Baker Faces Pain Scale, and adverse events. During the study, 38 women (mean [SD; 95% CI] age, 48.1 (8.4; 45.3–50.8 years)) received slings. Mean procedure time was 10.6 minutes, estimated blood loss was 23.2 mL, and length of stay was 1.3 hours. At discharge, the Wong-Baker pain score was 0.2 (0.0–2.0). At 2 years, 31 patients were available for follow-up. Of these, 93.5% had normal findings on the cough stress test, and 90.3% had pad weight <1 g; and 90.6% and 87.5%, respectively, using last failure carried forward analysis in 32 patients. The UDI-6 and IIQ-7 median scores showed a statistically significant decrease from baseline (p < .001). There were no reports of serious adverse events or of bowel, urethral, bladder, or major vessel perforation. ConclusionThe in-office experience suggests that implantation of a single-incision sling for treatment of stress urinary incontinence with the patient under intravenous or oral sedation and/or local anesthesia can be performed safely, with effective results. Thus, performing this procedure in an office setting is a viable option.

Three-Year Follow-Up of Tension-Free Vaginal Tape Compared With Transobturator Tape in Women With Stress Urinary Incontinence and Intrinsic Sphincter Deficiency

To compare the efficacy of tension-free vaginal tape (TVT) to transobturator tape in the treatment of women with stress urinary incontinence (SUI) and intrinsic sphincter deficiency at 3-year follow-up. One hundred sixty-four women were randomized to either TVT or transobturator tape after diagnosis of urodynamic stress incontinence and intrinsic sphincter deficiency. Concomitant pelvic organ prolapse surgery was not an exclusion criterion. The primary outcome assessed at 3-year follow-up was symptomatic stress incontinence requiring repeat surgery. Secondary outcomes were quality-of-life parameters assessed by validated questionnaires and numerical success score. One hundred sixty-four women were enrolled in the study. At 3 years, 15 of the 75 (20%) women in the transobturator tape group underwent repeat surgery to correct SUI compared with one of the 72 (1.4%) in the TVT group. In other words, if TVT had been used exclusively, repeat surgery would have been avoided in one in six patients. The risk ratio of repeat surgery was 15 (95% confidence interval 2-113; P<.001) times greater in the transobturator tape group. In the transobturator tape group, the median time to repeat surgery was 15.6 months compared with 43.7 months for TVT (P<.001). The quality-of-life outcomes did show an improvement in both groups before and after surgery but no difference between the two slings in the Urogenital Distress Inventory short form, the Incontinence Impact Questionnaire short form, and a patient-rated numerical success score. The long-term cure rates for retropubic TVT are significantly greater than for transobturator tape in women with urodynamic stress incontinence and intrinsic sphincter deficiency. Urethral functions tests such as urethral closure pressure and Valsalva leak point pressures are of value in determining what surgery to perform. Australian New Zealand Clinical Trials Registry, www.anzctr.org.au, ACTRN12608000093381. I.

Botulinum a toxin/dimethyl sulfoxide bladder instillations for women with refractory idiopathic detrusor overactivity: a phase 1/2 study.

We completed a phase 1/2 trial to evaluate the safety and potential efficacy of direct intravesical instillation of a botulinum type A toxin/dimethyl sulfoxide (DMSO) solution for treatment of idiopathic detrusor overactivity in women. Twenty-five women with medication-resistant, urodynamic-confirmed idiopathic detrusor overactivity were enrolled. A total of 9 patients were treated in phase 1 of the study. Three patients were given a 66% dosing of solution; 22 patients received the full 300 units of botulinum toxin and 50 mL of DMSO (50% concentration). Adverse effects, 24-hour pad weights, episodes of incontinence, postvoid residuals, and scores on the Blaivas-Groutz anti-incontinence scale, Indevus Urgency Severity Scale, Incontinence Impact Questionnaire-short form, and Urogenital Distress Inventory (6 items) questionnaire were recorded at baseline, 1 month, and 3 months after instillation. No serious adverse effects or clinically important increases in postvoid residual occurred. Among the 21 women who completed phase 2 of the study, the median number of incontinent episodes decreased from 4 at baseline to 2 at 1 month (P=.004) and increased to 4 at 3 months (P=.81). Median scores improved from baseline to 1 month on the Incontinence Impact Questionnaire (from 13 to 7; P=.007) and Urogenital Distress Inventory (from 10 to 5; P=.003). Although 11 women (52%) reported severe urgency based on the Indevus Urgency Severity Scale at baseline, only 1 (5%; P<.001) and 3 (14%; P=.004) women reported severe scores at 1 and 3 months, respectively. Direct instillation of botulinum toxin/DMSO solution is safe. Its promising clinical effect warrants further evaluation in a randomized, placebo-controlled phase 3 setting.

Male stress urinary incontinence: assessing patient-reported outcomes

Male stress urinary incontinence (SUI) is caused by intrinsic sphincter deficiency (ISD) from a variety of etiologies – prostatic surgery as the being the most common. SUI may sometimes be associated with overactive bladder symptoms. Based on the severity of symptoms and the associated level of bother, the patient may seek treatment. A treatment plan is elaborated after careful patient evaluation involving a combination of voiding diary, quality of life (QOL) questionnaires, flowmetry, urethrocystoscopy and urodynamics. The therapeutic options include conservative methods, such as pelvic floor exercises, or surgical modalities such as injectables, adjustable balloon therapy, slings and the artificial urinary sphincter (AUS). The success is defined by objective or subjective outcome measures. This retrospective study presents a global assessment of patient satisfaction and QOL in 37 men at a follow-up of 7 to 60 months after AUS.1 The investigators demonstrated an overall high QOL level based on a survey of patient-reported outcomes (PRO) composed of 4 questionnaires: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Post-Operative Patient Global Impression of Improvement (PGI-I), Incontinence Impact Questionnaire-Short Form (IIQ-SF) and Urogenital Distress Index (UDI-SF). Out of 34 patients, 31 would have an AUS placed again and recommend it to a friend with a similar problem. The authors concluded that the insertion of AUS positively impacted QOL and patient satisfaction.1 The economic burden of male SUI has been steadily increasing in the last 2 decades, with most of the increase occurring in the ambulatory surgery setting.2 Many patients are counselled for and chose a surgical intervention with hopes of cure. As incontinence is not alife-threatening, the patient must decide if the expected benefits outweigh the possible risks and complications of the surgery. His decision is therefore based on how severely his condition affects his QOL. It is crucial for the surgeon to establish realistic expectations, because they are direct determinants of a patient’s satisfaction following the intervention. Another consideration is the limited lifespan of a mechanical device, such as the AUS. The increasing risk of mechanical revision with long-term follow-up may signifi-cantly change patient satisfaction over time.3 The purpose of using PRO in incontinence research is to measure the impact of an intervention on the overall health status from a patient’s perspective. In clinical trials, these tools are ideally administered before and after treatment in a prospective fashion. Despite the wide availability of QOL questionnaires, there is little consensus about their applicability to guide treatment decision.4 Due to the retrospective nature of this study, we cannot compare the preoperative and postoperative scores of the QOL questionnaires. However, the desire to undergo surgical treatment can be used as a surrogate of significant QOL impairment before the intervention. Future clinical studies should prospectively measure PRO and correlate them with objective outcomes in homogeneous populations of patients to avoid any possible bias.

Validation of incontinence impact questionnaire short form in Chinese population

To study reliability and validity of incontinence impact questionnaire short form (IIQ-7) in the Chinese population. IIQ-7 form was translated into Chinese; 74 patients with urinary incontinence completed the IIQ-7 simplified Chinese version and short-form 12-item health survey (SF-12) questionnaires. The urinary incontinence patient also ran a 1 hour pad test. Then, reliability and validity of those forms were analyzed. The Cronbach's alpha of IIQ-7 simplified Chinese version was 0.824 (P<0.01). The intra-class correlation coefficient of IIQ-7 simplified Chinese version was 0.749 (P<0.01). IIQ-7 simplified Chinese version scores were negatively correlated with SF-12 scores (Spearman correlation coefficient: -0.570, P<0.01), IIQ-7 simplified Chinese version scores were positively correlated with 1 hour pad test (Spearman correlation coefficient: 0.461, P<0.01), IIQ-7 simplified Chinese version scores were also positively correlated with the course of disease (Spearman correlation coefficient: 0.235, P<0.05). Factor analysis of IIQ-7 simplified Chinese version showed good construct validity. The simplified Chinese version of IIQ-7 has higher reliability and validity in the Chinese population. They are highly recommended for clinical treatment and research.

Quality of Life after SPARC Sling Procedure: A Long-Term Retrospective Analysis

Introduction: To asses the effects on quality of life (QoL) in women with stress urinary incontinence after a SPARC sling procedure. Methods: This is a long-term retrospective study. The study cohort consisted of 54 women: 46 were available for follow-up examination and 8 were contacted by telephone. Results: The median follow-up was 5.3 years. The QoL assessed by using a visual analogue scale improved significantly from 6.9 at baseline to 2.8. The IIQ-7 (Incontinence Impact Questionnaire-Short Form) general score decreased from an average of 56.7 at baseline to 17.5 at the follow-up investigation. Using the Patient Global Impression of Improvement questionnaire, 57.4% of women characterized themselves as very much better, 20.4% as much better and 11.1% as a little better. Eighty-seven percent of women regarded themselves as satisfied, but 13% were dissatisfied with the outcome of the SPARC sling procedure. Conclusion: In this study a significant and stable long-term improvement in QoL could be observed in women undergoing SPARC sling procedure.

Quality of life and patient satisfaction after artificial urinary sphincter

We assessed satisfaction and quality of life (QOL) in men with artificial urinary sphincter (AUS) placement. We identified 39 men who had AUS placement. A retrospective chart review was conducted. Validated questionnaires, including the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Post-Operative Patient Global Impression of Improvement (PGI-I), Incontinence Impact Questionnaire-Short Form (IIQ-SF), and Urogenital Distress Index (UDI-SF), were used to measure patient-reported outcome. Global satisfaction was also assessed. At chart review, 34 of 39 questionnaires were assessed for QOL, satisfaction and surgical outcome. Follow-up ranged from 7 to 60 months (median = 24 months). Surgical revisions were required in 6 (17.6%) patients due to infection (1), erosion (1), combined infection and erosion (1), device failure (1) and second cuff placement (2). Quality of life was assessed using the IIQ-SF and UDI-SF, with mean scores of 15.4 and 24.8, respectively; these scores indicated a low negative impact on QOL. The ICIQ-SF mean score was 8.2, well below the worst possible score. The number of men using more than 1 pad per day dropped from 27 preoperatively to 10 postoperatively. Most patients (31/34) described their urinary condition as better, 2 had no change and 1 was worse. Most patients (31/34, 91.2%) would be willing to undergo the procedure again, 2 were undecided, and 1 would not. Similarly, 28 patients (82.4%) would recommend the procedure to a friend, 3 respondents would "with reservation," 1 respondent was undecided, and 2 would not recommend the AUS placement. Treatment of urinary incontinence with the AUS has a positive effect on QOL with high patient satisfaction and reasonably low complication rates.

Duloxetine for Mild to Moderate Postprostatectomy Incontinence: Preliminary Results of a Randomised, Placebo-Controlled Trial

BackgroundDuloxetine is effective in the management of stress urinary incontinence (SUI) in women but has been poorly evaluated in the treatment of SUI following radical prostatectomy (RP). ObjectiveTo establish the superiority of duloxetine over placebo in SUI after RP. Design, setting, and participantsWe conducted a prospective, randomised, placebo-controlled, double-blind, monocentric superiority trial. After a placebo run-in period of 2 wk, patients with SUI after RP were randomised to receive either 80mg of duloxetine daily or matching placebo for 3 mo. MeasurementsThe primary outcome measure was the relative variation in incontinence episodes frequency (IEF) at the end of study compared to baseline. Secondary outcomes included quality of life (QoL) measures (Incontinence Impact Questionnaire Short Form [IIQ-SF], Urogenital Distress Inventory Short Form [UDI-SF], Incontinence Quality of Life [I-QoL]), symptom scores (Urinary Symptom Profile [USP] questionnaire, International Consultation on Incontinence/World Health Organisation Short Form questionnaire [ICIQ-SF], the Beck Depression Inventory [BDI-II] questionnaire), 1-h pad test, and assessment of adverse events. Results and limitationsThirty-one patients were randomised to either the treatment (n=16) or control group (n=15). Reduction in IEF was significant with duloxetine compared to placebo (mean±standard deviation [SD] variation: −52.2%±38.6 [range: −100 to +46] vs +19.0%±43.5 [range: −53 to +104]; mean difference: 71.2%; 95% confidence interval [CI] for the difference: 41.0–101.4; p<0.0001). IIQ-SF total score, UDI-SF total score, SUI subscore of the USP questionnaire, and question 3 of the ICIQ-SF questionnaire showed improvement in the duloxetine group (p=0.006, p=0.02, p=0.0004, and p=0.003, respectively). Both treatments were well tolerated throughout the study period. ConclusionsDuloxetine is effective in the treatment of incontinence symptoms and improves QoL in patients with SUI after RP.

Prospective Evaluation of a Single Incision Sling for Stress Urinary Incontinence

We report 12-month outcomes of the MiniArc single incision sling for stress urinary incontinence in women. We performed a multicenter, prospective, single arm institutional review board/ethics committee approved study evaluating the effectiveness of the MiniArc sling after implantation via qualitative (Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form) and quantitative (1-hour pad weight test and cough stress test) measurements. Secondary outcome measures included procedural variables (procedure time and estimated blood loss), length of stay, perioperative complications, Wong-Baker Faces Pain Scale and adverse events. A total of 188 women with a mean age of 51.1 +/- 10.6 years (median 50.4, range 25.9 to 79.6) were enrolled in the study. At 1 year 157 patients were available for analysis. Mean procedure time, estimated blood loss and length of hospital stay were 11.0 +/- 6.7 minutes (median 10, range 2 to 55), 41.7 +/- 47.0 ml (median 25, range 0 to 250) and 9.5 +/- 14.1 hours (median 3.2, range 0.5 to 77.2), respectively. At discharge from hospital the mean Wong-Baker pain score was 1.3 +/- 2.0 (range 0.0 to 10.0). Of the patients 90.6% had a negative cough stress test and 84.5% had a 1-hour pad weight test less than 1 gm at 12 months. Median Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form scores showed a statistically significant decrease (p <0.001). Adverse events included urinary tract infection (4.3%), constipation (3.7%), temporary urinary retention (3.2%), dyspareunia (2.1%) and vaginal extrusion (1.6%). The MiniArc single incision sling is a safe and effective first line surgical procedure for the treatment of female stress urinary incontinence. It demonstrated excellent patient tolerability with minimal pain, early return to normal activity and low morbidity. In addition to sustained efficacy outcomes at 12 months patients treated with the MiniArc experienced a significant improvement in quality of life.

Comparison of intravaginal electrical stimulation and trospium hydrochloride in women with overactive bladder syndrome: a randomized controlled study

Objective: To compare the effects of trospium hydrochloride and electrical stimulation on urodynamic parameters, bladder diary, quality of life and psychological symptoms in female patients with overactive bladder syndrome. Design: Prospective, randomized controlled trial. Setting: Department of Physical Medicine and Rehabilitation, University Hospital. Subjects: Thirty-five patients were divided into either trospium chloride (Group 1) or intravaginal electrical stimulation therapy (Group 2). Main outcome measures: All patients were assessed at the beginning of the treatment, at weeks 6 (end of treatment), 10 and 18 according to urodynamic parameters, voiding diary parameters, severity of urgency (visual analogue scale, VAS), the Incontinence Impact Questionnaire Short Form (IIQ-7), and the Beck Depression Inventory. Results: Statistically significant improvements were observed in both groups according to some urodynamic parameters, voiding diary parameters, VAS urgency severity, Incontinence Impact Questionnaire Short Form and Beck Depression Inventory scores at the end of the treatment (P<0.05). During the 18-week follow-up period, deteriorations were observed in many parameters in both groups although improvements in the frequency of urgency, the frequency of incontinence episodes, VAS urgency severity, and Beck Depression Inventory score in Group 2 persisted (P<0.05). Significant differences were not detected between groups at the end of the treatment or during the posttreatment follow-up controls (P>0.05). Conclusion: No difference was detected between trospium hydrochloride and intravaginal electrical stimulation in the treatment of female overactive bladder syndrome. Discontinuation of both treatments caused deterioration in most of the objective and subjective symptoms of overactive bladder syndrome.

Chinese validation of Urogenital Distress Inventory and Incontinence Impact Questionnaire short form

UDI-6 and IIQ-7 are useful disease-specific questionnaires evaluating the impact of urinary incontinence on the QOL of women. We aim at validating them in Chinese language. Both instruments were translated; 207 urinary incontinent women completed UDI-6 and IIQ-7, SF-36, bladder diary and urodynamic evaluation. The reliability and validity were assessed. There were high internal consistency (Cronbach's alpha for UDI-6 and IIQ-7 was 0.80 and 0.93) and test-retest reliability (Intraclass correlation coefficient was 0.72 and 0.75, P < 0.001). Scoring of UDI-6 and IIQ-7 was negatively correlated with SF-36 (P < 0.001); positively correlated with daytime urinary frequency and incontinent episodes (P < 0.001), and women's VAS (P < 0.001). Subscales of UDI-6 and IIQ-7 could discriminate women with different urodynamic diagnoses. The Chinese UDI-6 and IIQ-7 is reliable and valid. Study on the responsiveness to treatment is in progress. They are useful in assessing impact of the urinary incontinence in Chinese women.

Urinary incontinence should be added to the manifestation in women with Marfan syndrome

We aimed to compare the incidence of urinary incontinence in women with Marfan syndrome and controls, hypothesizing that connective tissue abnormality could contribute to urinary incontinence. A cross-sectional historical cohort study was conducted on 14 premenopausal women with Marfan syndrome and 534 controls using Urogenital Distress Inventory Short Form and Incontinence Impact Questionnaire Short Form. Marfan subjects had significantly higher incidence of urinary symptoms, stress urinary incontinence (SUI) and urge urinary incontinence (UUI) than controls (P = 0.02, P = 0.03, P = 0.02), despite their lower parity (P = 0.01). Direct logistic regression analysis indicated that Marfan syndrome, parity and age were associated with SUI; while Marfan syndrome was the only significant predictor of UUI. Premenopausal women with Marfan syndrome had a higher incidence of reported urinary symptoms. Urinary incontinence should be added to the list of clinical manifestations in women with Marfan syndrome.

Quality of Life of Women with Urinary Incontinence: A Systematic Literature Review

The purpose of this study was to review studies that have examined the quality of life of women with urinary incontinence. A review was conducted that used the databases PubMED, Proquest, CINAHL, and Sciencedirect. Articles were included that were published in English between 2005 and 2010 the key words use were urinary incontinence, women, and quality of life. A total of 18 studies were identified, and the prevalence of urinary incontinence varied depending on the definition of incontinence used and the age of the population studied. The Incontinence Quality of Life (I-QoL), Incontinence Impact Questionnaire-short form (IIQ-7), and King's Health Questionnaire (KHQ) were the most commonly used instruments. Demographic, medical, physical, psychological, health, and intervention factors were reported as influencing factors on the quality of life of women with incontinence. Age, severity of urinary incontinence, type of urinary incontinence, number of urinary incontinence episodes, body weight, stress, and help-seeking behavior were statistically significant variables influencing quality of life. Future studies are needed to identify factors related to quality of life among women with incontinence and to use validated instruments according to specific subjects.

Racial differences in bother for women with urinary incontinence in the Establishing the Prevalence of Incontinence (EPI) study

The purpose of this study was to compare differences in degree of bother in black and white women with urinary incontinence (UI). A population-based study was conducted in black and white women in Michigan. Participants completed an interview and the Incontinence Impact Questionnaire short form (IIQ-7). Statistical analysis included 2-way analysis of variance for post hoc comparisons of IIQ-7 scores between races at different frequencies, amounts, and types of UI. Black women with moderate UI had significantly higher IIQ-7 scores than white women (31.4 +/- 3.5 vs 23.7 +/- 1.9; P = .03). Overall, black women with urge incontinence had higher scores than white women (30.5 +/- 4.0 vs 21.0 +/- 3.0; P = .05). After adjustment for severity, black women with urge and mixed incontinence tended to be more bothered (P = .06). With moderate UI (not mild or severe), black women are more bothered than white women. At this discriminatory level of UI severity, racial differences are important, because they may dictate care-seeking behavior.

Botulinum A Toxin/Dimethyl Sulfoxide Bladder Instillations for Women With Refractory Idiopathic Detrusor Overactivity: A Phase 1/2 Study

We completed a phase 1/2 trial to evaluate the safety and potential efficacy of direct intravesical instillation of a botulinum type A toxin/dimethyl sulfoxide (DMSO) solution for treatment of idiopathic detrusor overactivity in women. Twenty-five women with medication-resistant, urodynamic-confirmed idiopathic detrusor overactivity were enrolled. A total of 9 patients were treated in phase 1 of the study. Three patients were given a 66% dosing of solution; 22 patients received the full 300 units of botulinum toxin and 50 mL of DMSO (50% concentration). Adverse effects, 24-hour pad weights, episodes of incontinence, postvoid residuals, and scores on the Blaivas-Groutz anti-incontinence scale, Indevus Urgency Severity Scale, Incontinence Impact Questionnaire-short form, and Urogenital Distress Inventory (6 items) questionnaire were recorded at baseline, 1 month, and 3 months after instillation. No serious adverse effects or clinically important increases in postvoid residual occurred. Among the 21 women who completed phase 2 of the study, the median number of incontinent episodes decreased from 4 at baseline to 2 at 1 month (P=.004) and increased to 4 at 3 months (P=.81). Median scores improved from baseline to 1 month on the Incontinence Impact Questionnaire (from 13 to 7; P=.007) and Urogenital Distress Inventory (from 10 to 5; P=.003). Although 11 women (52%) reported severe urgency based on the Indevus Urgency Severity Scale at baseline, only 1 (5%; P<.001) and 3 (14%; P=.004) women reported severe scores at 1 and 3 months, respectively. Direct instillation of botulinum toxin/DMSO solution is safe. Its promising clinical effect warrants further evaluation in a randomized, placebo-controlled phase 3 setting.

Modified Transobturator Tape (Canal Transobturator Tape) Surgery for Female Stress Urinary Incontinence

To mitigate TOT complications we designed a modified TOT technique called canal TOT. We describe this new technique and evaluate its feasibility. Between October 2006 and June 2007, 105 consecutive women with stress urinary incontinence underwent a canal TOT procedure. Two oblique lateral incisions were made in the anterior vaginal wall and a suburethral canal was created between the incisions. Mesh was transferred beneath the canal. The subsequent canal TOT surgical steps were identical to those of the original TOT procedure. All patients were evaluated by urological examination and self-assessment questionnaires (Incontinence Impact Questionnaire-Short Form and Urogenital Distress Inventory-Short Form) preoperatively and 12 months postoperatively. Reportedly dyspareunia developed after the operation. A minimum 1-year followup was available in 99 patients. Median operative time was 25 minutes (range 15 to 50). No mesh erosion, retropubic hematoma or complete bladder retention developed. Transient postoperative voiding dysfunction and transient de novo urgency were observed in 2 (2.0%) and 8 patients (8.1%), respectively. Dyspareunia developed after surgery in 4 patients (4.0%). Postoperatively Incontinence Impact Questionnaire-Short Form and Urogenital Distress Inventory-Short Form scores decreased significantly (p <0.05). Objective and subjective cure rates were 98.0% and 89.9%, respectively. The canal TOT procedure is feasible and effective for mitigating the complications of the original TOT procedure. This technique might be especially useful in patients with cystocele because of the paravaginal defect as well as in patients with obesity or prior vaginal surgery. However, a large-scale and long-term followup study is required to verify the effectiveness of this technique.

INSTILLATION OF BOTULINUM A TOXIN (BTX)/DIMETHYL SULFOXIDE (DMSO) BLADDER SOLUTION FOR THE TREATMENT OF VOIDING DYSFUNCTION SECONDARY TO DETRUSOR OVERACTIVITY (DO) IN WOMEN: A PHASE I/II STUDY

To investigate the relationship between sleep disturbance, fatigue, and urinary incontinence (UI) and overactive bladder (OAB) symptoms among patients with OAB.Patients who were diagnosed with OAB and age-matched control subjects without OAB were enrolled. Sleep disturbance and fatigue symptoms were assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) short forms. UI and OAB symptoms were assessed using the International Consultation on Incontinence Questionnaire—Urinary Incontinence (ICIQ-UI), the International Consultation on Incontinence Questionnaire—Overactive Bladder (ICIQ-OAB), the Overactive Bladder Questionnaire (OAB-q), the Urogenital Distress Inventory Short Form (UDI-6), and the Incontinence Impact Questionnaire Short Form (IIQ-7). Psychosocial health (depression, anxiety, and perceived stress level) was also assessed.Patients with OAB reported a significantly greater sleep disturbance compared with controls (PROMIS 8b T-scores: 54.3 ± 10.3 vs 43.8 ± 9.2). Patients with OAB also reported a significantly greater fatigue compared with controls (PROMIS 7a T-scores: 54.7 ± 9.6 vs 46.0 ± 6.4). After adjusting for nocturia, the differences in sleep disturbance between OAB and controls became insignificant (P = .21), whereas the differences in fatigue between OAB and controls remained significant (P = .014). Among patients with OAB, there were positive correlations between sleep disturbance and the severity of OAB symptoms (ICIQ-OAB), poorer health-related quality of life (OAB-q QOL), the severity of UI symptoms (ICIQ-UI), greater incontinence impact (IIQ-7), and urinary bother (UDI-6). Positive correlations were also observed between fatigue and worse UI and OAB symptoms and quality of life. Both sleep disturbance and fatigue were associated with poor psychosocial health (depression, anxiety, and higher stress level) among patients with OAB.Sleep disturbance and fatigue are present in substantial percentages of patients with OAB. Among patients with OAB, sleep disturbance and fatigue were associated with more severe UI and OAB symptoms, worse health-related quality of life, and poorer psychosocial health.

Surgical Outcomes after Distal Suburethral Sling Procedures for Stress Urinary Incontinence in Aged Patients

Purpose: There are few reports describing objective and subjective outcomes in aged patients undergoing distal urethral polypropylene sling (DUPS) and canal transobturator tape (canal TOT) placement, which make the submucosal mesh ‘tension-free’ state in the operating room. We evaluated surgical outcomes and subjective satisfaction in patients over 70 years of age who underwent DUPS and canal TOT for the treatment of stress urinary incontinence (SUI). Materials and Methods: We studied 29 consecutive patients over 70 years of age who underwent DUPS and canal TOT for genuine SUI between January 2006 and April 2008. Surgical outcomes were determined on the basis of hemoglobin change, operative time, hospital stay, and complications. Subjective satisfaction was determined on the basis of disease-specific quality of life, measured via the Incontinence Impact Questionnaire-short form (IIQ-7) and the Urogenital Distress Inventory-short form (UDI-6). Results: No intraoperative or major postoperative complications were reported. No concomitant procedures were performed, including cystocele repair (n=0) or rectocele repair (n=0). The mean IIQ-7 and UDI-6 scores both decreased significantly after DUPS and canal TOT. Moreover, 82% of patients reported no SUI symptoms under any circumstances, and 91% of patients reported being rarely or never bothered by SUI symptoms. Conclusions: The surgical outcomes and subjective satisfaction seen with DUPS and canal TOT in this study were superior to those seen in other studies. However, it is possible that this study overestimated the effects of DUPS and canal TOT in aged women because of the small study sample. Therefore, additional studies are needed. (Korean J Urol 2009;50:969-975) 󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏