Incontinence Quality Of Life Scores Research Articles

Editorial Comment

Editorial Comment

Outcome and Management of Patients in Whom Sacral Nerve Stimulation for Fecal Incontinence Failed

Sacral nerve stimulation fails in 30% to 50% of patients, the outcome that remains largely unreported. We report on the management and outcome of this cohort of patients. Ninety-one patients (88 females) with fecal incontinence, median age 63 years (range, 37-81), were candidates for sacral nerve stimulation. The follow-up protocol comprised incontinence and quality-of-life scores. Failure was defined on an intention-to-treat basis: after the test (<50% decrease of fecal incontinence episodes) or after permanent implantation (Wexner score >8). Subsequent management and functional results were recorded. The mean Wexner score for the cohort decreased from 14.3 at baseline to 7.6 after a median follow-up of 31 months (range, 11-69). Sixty-one (67.0%) patients were implanted with a permanent pacemaker; 36 (39.6%) achieved success (group 1). Failure after permanent implantation occurred in 25 (27.5%) patients after a mean of 34.5 months (group 2). Failure after the test occurred in 30 (33.0%) patients, 12 of whom underwent further surgery (group 3) (including stoma, 2; anal reconstruction, 9; and rectopexy, 1), whereas the remainder chose conservative treatment (group 4). At the end of follow-up, group 1 had significantly lower Wexner scores compared with the rest (P < .0001) and superior Fecal Incontinence Quality of Life scores compared with groups 2 and 4 (P < .0001). Group 3 achieved a greater reduction in Wexner scores compared with groups 2 and 4 (P = .04), although the improvement in Fecal Incontinence Quality of Life scores did not reach statistical significance. This was a nonrandomized study with retrospective stratification of patients. On an intention-to-treat basis, success can be achieved in up to 40% of patients undergoing sacral nerve stimulation. In those in whom sacral nerve stimulation fails, further surgical treatment can yield favorable results in adequately motivated patients.

Is Patient-Perceived Severity of a Geriatric Condition Related to Better Quality of Care?

Care for falls and urinary incontinence (UI) among older patients is inadequate. One possible explanation is that physicians provide less recommended care to patients who are not as concerned about their falls and UI. To test whether patient-reported severity for 2 geriatric conditions, falls, and UI, is associated with quality of care. Prospective cohort study of elders with falls and/or fear of falling (n = 384) and UI (n = 163). Participants in the Assessing Care of Vulnerable Elders-2 Study (2002-2003), which evaluated an intervention to improve the care for falls and UI among older (age, ≥ 75) ambulatory care patients with falls/fear of falling or UI. Falls Efficacy Scale (FES) and the Incontinence Quality of Life surveys measured at baseline, quality of care measured by a 13-month medical record abstraction. There was a small difference in falls quality scores across the range of FES, with greater patient-perceived falls severity associated with better odds of passing falls quality indicators (OR: 1.11 [95% CI: 1.02-1.21] per 10-point increment in FES). Greater patient-perceived UI severity (Incontinence Quality of Life score) was not associated with better quality of UI care. Although older persons with greater patient-perceived falls severity receive modestly better quality of care, those with more distressing incontinence do not. For both conditions, however, even the most symptomatic patients received less than half of recommended care. Low patient-perceived severity of condition is not the basis of poor care for falls and UI.

Efficacy and Safety of the TVT-SECUR® and Impact on Quality of Life in Women with Stress Urinary Incontinence: A 2-Year Follow-Up

PurposeAs recently reported, the short-term results of the tension-free vaginal tape SECUR® (TVT-S) procedure seem to be similar to those of the conventional transobturator tape (TOT) procedure. However, results of efficacy and satisfaction with TVT-S are insufficient in patients with more than 1 year of follow-up. Therefore, we evaluated the results of the TVT-S procedure in women with stress urinary incontinence (SUI) during 2 years.Materials and MethodsWe evaluated 51 patients with clinical and urodynamic diagnoses of SUI who underwent the TVT-S procedure from March 2008 to February 2009. Preoperative evaluation included a history, cough stress test with full bladder, urodynamic study, and incontinence quality of life (I-QoL) questionnaire. Following the postoperative period, urinary incontinence status was examined through a physical examination and the I-QoL questionnaire was completed in an outpatient setting or by telephone.ResultsData from 2 years of follow-up were available for 46 of 51 patients. The cure rate was 80.4% at 1 month after TVT-S and 76.0% at 2 years after TVT-S. The cure or improvement rate was 93.5% at 1 month after TVT-S and 86.8% at 2 years after TVT-S. The mean total I-QoL score increased by 42 points at 1 month after TVT-S (p<0.026) and by 32 points at 2 years after TVT-S (p<0.013). Most patients reported significant improvements in quality of life. At the 2-year follow-up, there were no significant complications related to TVT-S.ConclusionsThe results of this study suggest that TVT-S is an efficient and safe procedure for the improvement of both the quality of life of the patients and the SUI itself.

Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18‐month results from a prospective long‐term study

To evaluate 18-month safety and durability of efficacy of nonsurgical transurethral collagen denaturation as treatment for stress urinary incontinence (SUI) in women. Study comprised women with SUI due to bladder outlet hypermobility for at least 12 months who failed conservative treatment and had not undergone surgery or bulking agent treatment. This one-time procedure was performed in a physician's office or ambulatory treatment center. Patients kept voiding diaries and completed the Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), and Patient Global Impression of Improvement measures at baseline and at 3, 6, 12, and 18 months posttreatment. At 18 months, intent-to-treat analysis revealed that patients experienced significant reductions in the median number of stress leaks daily (0.43; P < 0.006) and weekly (3.0; P < 0.006) versus baseline, with 46.7% reporting a 50% or greater reduction in leakage. Mean I-QOL score improved 10.9 points (median 8.5; P < 0.0001), with 47.8% having a 10-point or greater improvement and 50.4% reporting improved symptoms versus baseline. Mean UDI-6 improvement was 13.0 points, with a stress incontinence subscore improvement of 17.0 points. Overall, 47.0% of patients were "somewhat" or "very" satisfied, and 52.9% would recommend the procedure to a friend. The procedure was shown to be safe and effective, with no new treatment-related adverse events reported at 18 months. Transurethral collagen denaturation resulted in significant improvements in stress leaks and quality of life for at least 18 months. This procedure offers a safe, effective, nonsurgical treatment option for women with SUI.

A pilot study of ultrasound guided Durasphere injection in the treatment of faecal incontinence

To assess injection of Durasphere under direct endoanal ultrasound guidance as a treatment for faecal incontinence. A total of 23 patients with varying degrees of persistent faecal leakage and/or soiling were recruited. Durasphere was injected in the intersphincteric plane under direct ultrasound guidance. All patients were given a general anaesthetic. Patients had ano-rectal physiology, endoanal ultrasound, continence scoring and quality of life measures assessed at 0, 1, 3, 6 and 12 months. A total of 21 patients were followed up for at least 12 months, with two being excluded at the follow-up stage. Friedman two-way analysis of variance of the Cleveland Clinic Score, Faecal Incontinence Quality of Life Score and Diary Response Score demonstrated a significant sustained improvement. There was no significant improvement in number of bowel movements. There was a significant difference in anal squeeze pressure after therapy, but no significant difference in anal resting pressure. Six patients reported no improvement after Durasphere therapy. Durasphere gave sustained improvements in quality of life and continence scores in this study group. Strict criteria are needed to ascertain suitability for Durasphere therapy.

Transurethral injection of bulking agent for treatment of failed mid-urethral sling procedures

We evaluated the efficacy of transurethral injection (TUI) for the treatment of recurrent or persistent stress urinary incontinence after mid-urethral sling (MUS) procedures. A retrospective study was conducted among 23 women who had undergone TUI for failed MUS using bulking agents, Macroplastique® and Durasphere®. The Sandvik questionnaire, Subjective Symptom Visual Analogue Scale (VAS), Incontinence Quality of Life (I-QOL) assessment, and Benefit, Satisfaction, and Willingness to Continue questionnaire were used to evaluate the efficacy of TUI. The cure rate was 34.8% for a median follow-up of 10 months. Subjective symptom VAS, total, and all domains of I-QOL scores were significantly improved after TUI. Ninety-two percent of the patients reported a benefit and 77% of the patients were satisfied with the treatment. TUI for failed MUS demonstrated a low cure rate but high patient satisfaction, and the procedure was minimally invasive with no significant complications.

Artificial Bowel Sphincter Implantation for Faecal Incontinence in Asian Patients

To evaluate the outcomes with the American Medical Systems artificial bowel sphincter (ABS) implantation for the treatment of intractable faecal incontinence in an Asian population. Six Asian patients who underwent ABS implantation between March 2004 and December 2007 for the treatment of faecal incontinence were reviewed. The ABS was successfully implanted in six patients [mean age 50 (20-73) years; 4 males]. The most common causes of incontinence were congenital anomaly of the anus (imperforate anus status post a pull-through procedure) and status-post ultralow anterior resection. Two patients required device explantation due to postoperative infection. One eventually required a colostomy. After a mean follow-up of 22 (4-36) months, four patients continued to have a functional artificial bowel sphincter. Faecal incontinence severity scores improved from a mean of 13 (12-14) to 6 (0-9) postactivation. Anal manometry showed an increase in mean resting pressures (19.2 +/- 7.5 mmHg vs. postimplantation with cuff inflated 45.0 +/- 12.0 mmHg). The comparative preoperative and postactivation faecal incontinence quality of life scores showed improvement in all aspects. Patients with successful ABS implantation benefited from improved outcomes in function and quality of life. Infection was the most common cause of failure in our patients.

Sacral Nerve Neuromodulation Is Effective Treatment for Fecal Incontinence in the Presence of a Sphincter Defect, Pudendal Neuropathy, or Previous Sphincter Repair

To assess the effectiveness of sacral nerve neurostimulation in the setting of sphincter defects, previous sphincter repair, or pudendal neuropathy. A total of 55 patients underwent insertion of a sacral nerve neurostimulator for fecal incontinence. There were 52 female and 3 male patients, with a mean age of 51 (range, 25-65) years and a median follow-up of 37 (range, 15-41) months. There was a significant improvement in the median Cleveland Clinic continence score for all of the patients, from a median of 15 (13-18) before insertion of the neurostimulator, to a median of between 4 and 7 during the follow-up period of up to 48 months. (P < .001-.008). Patients with a sphincter defect on endoanal ultrasound, a pudendal neuropathy, or a previous sphincter repair did not show any significant differences in continence scores during the follow-up period (P = .46, .25, and .81, respectively). The Fecal Incontinence Quality of Life score also showed a significant improvement on all 4 scales, Lifestyle (median 2.00 baseline to 3.00-3.70 P = .001-.008), Coping/Behavior (median 1.56 baseline to 2.89-3.22 P = .001-.007), Depression/Self-Perception (median 2.29 baseline to 2.93-3.71 P = .001-.005), and Embarrassment (median 1.50 baseline to 2.17-3.00 P = .001-.013) after insertion at all time intervals up to 36 months. The Fecal Incontinence Quality of Life score was higher than the baseline at 48 months but only statistically significant for Lifestyle (median 3.10, P = .04) and Coping/Behavior (median 2.63, P = .03) scores. There were 6 device-related complications. Sacral nerve neuromodulation results in a significant improvement in fecal incontinence and Fecal Incontinence Quality of Life scores after medium-term follow-up, even when there is a sphincter defect or pudendal neuropathy.

Durability of Urethral Bulking Agent Injection for Female Stress Urinary Incontinence: 2-Year Multicenter Study Results

We evaluated the durability of the urethral bulking agent Macroplastique for stress urinary incontinence in a 24-month study in women with a previously documented successful outcome 12 months after the last injection. In a multicenter study females diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency successfully treated with Macroplastique, defined as 1 or greater Stamey grade improvement 12 months from baseline, were followed for 24 months to assess the sustained therapeutic response. Outcome measures were Stamey grade, Patient Global Impression of Improvement, Physician Assessment of Improvement, 1-hour pad weight, Incontinence Quality of Life scores and safety assessment. At 24 months 56 of 67 patients (84%) had sustained success since 12 months, of whom 45 of 67 (67%) were dry (Stamey grade 0). Of the dry patients at 12 months 33 of 38 (87%) maintained cure at 24 months. Also, 12 of 29 patients (41%) considered improved at 12 months were dry at 24 months. Overall Incontinence Quality of Life scores and all subscales showed statistically significant improvement from baseline (p <0.001). Mean pad weight was 24 gm at baseline, and 4 gm at 12 and 24 months. Patient and physician assessments rated 85% of patients dry or markedly improved 24 months after the last treatment. Substantial, durable results were sustained during 2 years with 84% of patients maintaining significant Stamey grade improvement from the 12-month assessment. Two-thirds of patients were dry at 24 months. The durability of Macroplastique shows its effectiveness as a viable long-term therapy for female stress urinary incontinence primarily due to intrinsic sphincter deficiency.

A Prospective Multicenter Randomized Comparative Study Between the U- and H-type Methods of the TVT SECUR Procedure for the Treatment of Female Stress Urinary Incontinence: 1-Year Follow-Up

BackgroundNo studies have been published comparing the U- and H-type methods of the TVT SECUR (TVT-S) procedure. ObjectiveOur aim was to compare the efficacy and safety of the two types of TVT-S for female stress urinary incontinence (SUI). Design, setting, and participantsWomen with urodynamic SUI were enrolled in this 12-mo multicenter randomized study. InterventionSubjects were randomly allocated to either the U- or H-type method of TVT-S. MeasurementsPre- and postoperative evaluations included a standing stress test, the Sandvik questionnaire, the Incontinence Quality of Life (I-QOL) questionnaire, and the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). Patients’ satisfaction and complications were evaluated. Objective and subjective cures were defined as no leakage on the stress test and responses on the Sandvik questionnaire, respectively. We compared the surgical outcomes between the two methods. Results and limitationsOf 285 women, 144 had the U-type method and 141 had the H-type method. Objective cure rates were 87.5% for the U-type method and 80.1% for the H-type method (p=0.091). Subjective cure rates were 77.1% for the U-type method and 75.7% for the H-type method (p=0.786). Improvement in I-QOL and domain scores of the ICIQ-FLUTS (filling and incontinence sum, QOL score), and patients’ satisfaction favored the U-type method. There were three cases of intraoperative vaginal wall perforation, one case of increased bleeding, and three cases of temporary postoperative retention. A power calculation was not performed, and some baseline characteristics were not balanced between the two methods. ConclusionsBoth methods of TVT-S provided comparable cure rates for female SUI. However, QOL and treatment satisfaction favored the U-type method. Trial registrationThe protocol of this study was not registered.

Impact of the Midurethral Sling Procedure on Quality of Life in Women with Urinary Incontinence

PurposeThis study was designed to objectively assess the impediment of incontinence to quality of life (QoL) in females and its improvement by the midurethral sling (MUS) procedure.Materials and MethodsFrom June 2006 to June 2007, 93 female patients underwent the MUS procedure at our institute because of urinary incontinence. The incontinence quality of life (I-QoL) questionnaire was administered to measure the QoL of the incontinent patients before and 1 and 12 months after the MUS procedure. Preoperative data and urodynamic factors were analyzed retrospectively by I-QoL scores to identify factors that may affect the QoL of incontinent patients.ResultsThe average preoperative I-QoL score of the 93 patients was 61.1±21.0 points. At 1 year after surgery, the average I-QoL score was found to have improved to 98.4±20.7 points. There were no significant differences between stress and mixed urinary incontinence in terms of cure and satisfaction (p>0.05). I-QoL scores of the cured and improved patients increased at 1 year after surgery (p<0.01). There were no statistically significant differences in the increment of I-QoL between cured and improved patients (p>0.05). Although urinary urgency and large urine leak amounts significantly reduced preoperative QoL in incontinent patients, the MUS procedure effectively improved the QoL regardless of these factors.ConclusionsPreoperative I-QoL assessment revealed a significant impairment of QoL in incontinent women, but the MUS procedure effectively improved these women's QoL.

The Effects of Pelvic Floor Muscle Training on Stress and Mixed Urinary Incontinence and Quality Of Life

To evaluate the effects of pelvic floor muscle (PFM) training on urinary incontinence (UI) and quality of life in women diagnosed with stress or mixed UI. We completed a parallel group, randomized clinical trial evaluating the effectiveness of PFM training in women with stress or mixed UI. We recruited consecutive cases of women with stress or mixed UI from outpatient urology clinics attached to a county hospital and a university hospital in Izmir, Turkey. After baseline evaluation, 41 women were randomly assigned to either the PFM training group or the control group. Muscle training included 3 sets of daily fast and slow contractions in lying, sitting, and standing positions. Participants were also taught the knack. The intervention period was 8 weeks, and the women in the exercise group telephoned once a week to provide motivation. The untreated control group had no contact during the intervention period. Outcome measures were Incontinence Quality of Life (I-QOL) Questionnaire, episodes of leakage in 3-day bladder diary, 1-hour pad test, and PFM strength. Thirty-four women completed the trial. The mean age of women was 41.82 +/- 8.65 years in the exercise group and 44.64 +/- 6.90 years in the control group. The 2 groups were statistically similar regarding key demographic and clinical characteristics. After 8 weeks, significant differences in the 1-hour pad test, episodes of leakage in 3-day bladder diary, PFM strength, and I-QOL scores (P = .01) were noted when participants in the PFM training group were compared to control group participants. An 8-week trial of PFM training significantly increased PFM strength, improved quality of life, and reduced the frequency of UI episodes.

Ten-Year Outcome After Anal Sphincter Repair for Fecal Incontinence

This study aimed to report at ten years on the results of the same cohort that had been studied at five years who had undergone an anal sphincter repair for fecal incontinence. Patients studied at five years were contacted after ten years and asked to fill out the Fecal Incontinence Quality of Life Scale, the Fecal Incontinence Severity Index, and the Bristol Stool Form Scale. Thirty-one of 44 (71 percent) patients were contacted. Median follow-up time was 129 (range, 113 to 208) months. Median age at surgery was 44 (range, 22 to 80) years. No patients were fully continent at 129 months. Fecal Incontinence Severity Index and Fecal Incontinence Quality of Life scores were correlated with the age at surgery. Older patients had lower Fecal Incontinence Quality of Life scores (P = 0.001), reflecting a lower quality of life, and a higher patient-rated Fecal Incontinence Severity Index score (P = 0.01) and a higher surgeon-rated Fecal Incontinence Severity Index score (P = 0.005), denoting more severe fecal incontinence. The Bristol Stool Form Scale, not utilized at 77 months, showed a correlation to patient-rated Fecal Incontinence Severity Index (P = 0.04) and surgeon-rated Fecal Incontinence Severity Index (P = 0.02). Fecal Incontinence Severity Index scores were significantly higher in women who had more than two vaginal births. Continence after overlapping sphincter repair deteriorates in the long term. Long-term outcome was worse for patients who were older at the time of surgery or those with two or more vaginal births. The Bristol Stool Form Scale score correlates with the severity of incontinence, and may be used to guide the management of the patient's symptoms.

Urodynamic Changes and Initial Results of the AdVance Male Sling

To present the urodynamic changes and early results associated with the AdVance male sling. The AdVance male sling is a treatment option for postprostatectomy incontinence (PPI), with the goal of eliminating urinary incontinence without affecting voiding parameters. A concern of any procedure in treating men with PPI is whether the treatment induces obstruction and causes retention. Data were prospectively collected from 13 patients undergoing AdVance male sling placement for PPI. Urodynamic testing was performed at baseline and repeated at 6 months postoperatively. A 24-hour pad test and the Incontinence Quality of Life questionnaire were completed preoperatively and at 3 and 6 months postoperatively. The median age at the procedure was 63.3 years (range 44.7-74.7). The mean preoperative and 6-month postoperative patient-reported pad use was 4.52 and 1.04, respectively (2-tailed t test, P = .0009). The 24-hour pad test, performed preoperatively and at 6 months postoperatively, yielded a pad weight of 779.3 and 67.6 g, respectively (P = .03). The Valsalva leak point pressure improved significantly (P = .032), but the detrusor voiding pressure, postvoid residual urine volume, and maximal and average flow rates remained relatively unchanged. At 3 and 6 months postoperatively, the Incontinence Quality of Life scores had improved significantly compared with the preoperative scores (P <.01). These results are encouraging, because this series has demonstrated a significant improvement in patient-reported pad use, 24-hour pad test weights, and Valsalva leak point pressure without signs of obstruction. The improvement in incontinence was accompanied without any changes in the other voiding parameters and with significant improvement in the quality-of-life measures. Ongoing studies with longer follow-up are pending to compare their results with these promising early results.

Nonsurgical Transurethral Collagen Denaturation for Stress Urinary Incontinence in Women: 12-Month Results from a Prospective Long-term Study

Study Objective To assess efficacy of nonsurgical transurethral collagen denaturation (Renessa) in women with stress urinary incontinence (SUI) caused by bladder outlet hypermobility. Design Continuing, prospective, 36-month, open-label, single-arm clinical trial. Twelve-month results from intent-to-treat (ITT) analysis are reported. Canadian Task Force classification II-2. Setting Thirteen physician offices or ambulatory treatment centers. Patients Women with SUI secondary to bladder outlet hypermobility for 12 months or longer who failed earlier conservative treatment and had not received earlier surgical or bulking agent therapy. Interventions Women were treated as outpatients and received an oral antibiotic and local periurethral anesthesia before undergoing treatment with transurethral radiofrequency collagen denaturation. Measurements and Main Results Voiding diaries and in-office stress pad weight tests yield objective assessments. Subjective measures include the Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), and Patient Global Impression of Improvement (PGI-I) instruments. In total, 136 women received treatment (ITT population). Patients experienced significant reductions versus baseline in median number of leaks caused by activity/day and activity/week (p <.0026 for both), with 50% of patients reporting 50% or more reduction. Pad weight tests revealed that 69% of women had 50% or more reduction in leakage (median reduction 15.2 g; p <.0001); 45% were dry (29% no leaks; 16% < 1-g leakage). Significant improvements occurred in median scores on the I-QOL (+9.5 [range –66.0 to 91.0]; p <.0001) and mean scores on the UDI-6 (–14.1 ± 24.7; p <.0001). Furthermore, 71.2% showed I-QOL score improvement, including 50.3% with 10-point or greater improvement, and 49.6% reported on the PGI-I that they were “a little,” “much,” or “very much” better. Conclusion At 12 months, treatment of SUI with nonsurgical transurethral collagen denaturation resulted in significant improvements in activity-related leaks and quality of life.

Sacral Nerve Stimulation is more Effective than Optimal Medical Therapy for Severe Fecal Incontinence: A Randomized, Controlled Study

This randomized study was designed to compare the effect of sacral neuromodulation with optimal medical therapy in patients with severe fecal incontinence. Patients (aged 39-86 years) with severe fecal incontinence were randomized to have sacral nerve stimulation (SNS group; n = 60) or best supportive therapy (control; n = 60), which consisted of pelvic floor exercises, bulking agent, and dietary manipulation. Full assessment included endoanal ultrasound, anorectal physiology, two-week bowel diary, and fecal incontinence quality of life index. The follow-up duration was 12 months. The sacral nerve stimulation group was similar to the control group with regard to gender (F:M = 11:1 vs. 14:1) and age (mean, 63.9 vs. 63 years). The incidence of a defect of < or = 120 degrees of the external anal sphincter and pudendal neuropathy was similar between the groups. Trial screening improved incontinent episodes by more than 50 percent in 54 patients (90 percent). Full-stage sacral nerve stimulation was performed in 53 of these 54 "successful" patients. There were no septic complications. With sacral nerve stimulation, mean incontinent episodes per week decreased from 9.5 to 3.1 (P < 0.0001) and mean incontinent days per week from 3.3 to 1 (P < 0.0001). Perfect continence was accomplished in 25 patients (47.2 percent). In the sacral nerve stimulation group, there was a significant (P < 0.0001) improvement in fecal incontinence quality of life index in all four domains. By contrast, there was no significant improvement in fecal continence and the fecal incontinence quality of life scores in the control group. Sacral neuromodulation significantly improved the outcome in patients with severe fecal incontinence compared with the control group undergoing optimal medical therapy.

Biofeedback vs . Electrostimulation in the Treatment of Postdelivery Anal Incontinence: A Randomized, Clinical Trial

This study was designed to evaluate the effect of biofeedback and electrostimulation in a randomized, clinical trial for the treatment of patients with postdelivery anal incontinence. Forty-nine females who sustained third-degree or fourth-degree perineal rupture with a mean age of 36 (range, 22-44) years were included in the study. The females were randomized to biofeedback or electrostimulation treatment. Forty females completed the study: 19 in the biofeedback and 21 in the electrostimulation group. Biofeedback or electrostimulation sessions were performed two times daily for eight weeks in each group. Wexner incontinence score, fecal incontinence quality of life scores, and reduced quality of life on visual analog scale were registered before and after treatment. Patients' self-rating of treatment effect also was registered in both groups. The primary outcome measure was the Wexner incontinence score. There were no differences in treatment effect between groups. Comparing pretreatment status to posttreatment in each group showed no improvement in Wexner score, reduced quality of life, or any of the fecal incontinence quality of life scores. Patients' self-rating of the treatment effect, however, showed a subjective improvement of symptoms both in the biofeedback and in the electrostimulation group (median, 7 vs. 5.) This study shows that there was no difference in effect between biofeedback and electrostimulation. Neither biofeedback nor electrostimulation treatments improved Wexner incontinence score, reduced quality of life, or fecal incontinence quality of life scores. Both treatments resulted in improvement of patients' subjective perception of incontinence control.

A multicenter, prospective, randomized clinical trial comparing tension‐free vaginal tape surgery and no treatment for the management of stress urinary incontinence in elderly women

The aim of our study was to test the hypothesis that elderly women undergoing tension-free vaginal tape surgery (TVT) will have a better quality of life (QOL) and satisfaction compared to non-treated women despite age- and technique-related potential morbidity. This multicenter, prospective, randomized, controlled trial enrolled a total of 69 women aged over 70 years who initially consented to be randomized to either undergo immediate TVT surgery or to wait for 6 months before submitting to the same surgery (control group). The main outcomes measured at every visit (pre-randomization, 8-12 weeks and 6 months) consisted of the Incontinence-Quality of Life (I-QOL) Questionnaire, the Patient Satisfaction Questionnaire and the Urinary Problems Self-assessment Questionnaire, among others. The analysis included 31 patients in the immediate surgery group and 27 subjects in the control group. Peri-operative complications in the immediate surgery group were bladder perforation (22.6%), urinary retention (12.9%), urinary tract infection (3.2%) and de novo urgency (3.2%). At 6 months, the mean I-QOL scores for the TVT and control groups were respectively 96.5 +/- 15.5 and 61.6 +/- 19.8 (P < 0.0001); mean Patient Satisfaction scores were respectively 8.0 +/- 2.7 and 2.0 +/- 2.4 (P < 0.0001); and mean Urinary Problems scores were respectively 4.5 +/- 4.3 and 11.6 +/- 3.5 (P < 0.0001). At 6 months post-randomization, the group of elderly women who underwent immediate TVT surgery showed a significant improvement in QOL, patient satisfaction and less urinary problems compared to the group of women waiting for the same surgery.

Nonsurgical, radiofrequency collagen denaturation for stress urinary incontinence: retrospective 3-year evaluation

Transurethral radiofrequency collagen denaturation, a nonsurgical treatment for stress urinary incontinence, reduces regional dynamic tissue compliance without causing tissue necrosis or gross tissue shrinkage, unlike transvaginal radiofrequency tissue ablation. This retrospective study evaluated long-term safety and efficacy in 21 patients from a 12-month, randomized controlled trial utilizing 3-day diaries and the Incontinence Quality of Life (I-QOL) survey. Significant increases in overall I-QOL scores 3 years or more post treatment was the primary end point. Secondary end points were reductions in frequency and severity of incontinence episodes. After 3 years, mean overall I-QOL score improvement was 12.7 (±26); 56% of patients achieved 50% or more reduction in frequency. No new adverse events occurred. These results indicate that radiofrequency collagen denaturation is safe and provides durable efficacy.