Reduction In Pad Weight Research Articles

A Vaginal Inlay for Reduction of Stress Urinary Incontinence: Outcome of a Randomized Clinical Trial and Four User Acceptance Studies.

A multicenter, randomized, controlled clinical trial and four postmarket user acceptance investigations were carried out to document the safety, performance, and user acceptance of Efemia Bladder Support, a novel vaginal inlay for the temporary reduction of stress urinary incontinence (SUI). The clinical investigation enrolled 97 women diagnosed with SUI, randomized 3 : 1 to either treatment or standard care (control). The primary endpoint was reduction of urine leakage, measured as change in pad weight baseline week compared with treatment week. Secondary endpoints were treatment success, calculated as the percentage of subjects with >70% reduction in pad weight, reduction in incontinence episodes, and quality of life (QoL). 75 women (77%) completed the clinical investigation. No serious adverse events occurred. The treatment group reached a 55% (p < 0.001) mean reduction of total leakage compared to the control arm. A subanalysis, involving only leakage during provocation testing (coughing and jumping), showed a 67% (p < 0.001) mean reduction of leakage. No significant effect on QoL could be observed. 51% of the women answered “yes” to the question if they would use the device to reduce SUI. The user acceptance of the device was further investigated in four postmarket studies, using an improved device design with a slimmer centerpiece and a thinner handle, while keeping the effect achieving parts of the device unchanged. An average of 74% of the 102 participants in the postmarket studies reported that they were likely to continue using Efemia. The highest user satisfaction was seen in the two studies evaluating the use of Efemia during exercise, where 83% and 88% of the women were likely to continue using Efemia. It can be concluded that Efemia is a safe, well-tolerated, and effective alternative for reducing SUI, both in everyday life and during physical exercise.

A 12-month feasibility study to investigate the effectiveness of cryogen-cooled monopolar radiofrequency treatment for female stress urinary incontinence.

The purpose of this early feasibility study was to evaluate the safety and efficacy of a non-ablative, cryogen-cooled, monopolar radiofrequency (CMRF) treatment for female stress urinary incontinence (SUI). Subjects meeting all the inclusion and exclusion criteria were enrolled and randomized into two groups. Subjects in group 1 received one CMRF treatment and subjects in group 2 received two CMRF treatments six weeks apart. Followup visits were performed at one, four, six, and 12 months post-treatment. At each study visit, subjects performed an objective, standardized one-hour pad weight test and completed several patient-reported outcome measures, a seven-day bladder voiding diary, and safety assessments. Data indicate an improvement in SUI symptoms and quality of life for subjects, as determined by validated SUI-related patient-reported outcomes and the objective one-hour pad weight test, with a >50% reduction in pad weight from baseline for 52% of the subjects at 12 months. In addition to efficacy, the CMRF treatment was well-tolerated and safe. The outcome measures evaluated indicate an improvement in SUI symptoms and quality of life. The sustained benefit of the CMRF vaginal treatment at 12 months suggests potential use as an office-based, non-surgical approach to treat mild to moderate SUI.

Four-year follow-up on 68 patients with a new post-operatively adjustable long-term implant for post-prostatectomy stress incontinence: ProACT™.

This paper presents 4-year follow-up results for patients enrolled in a pivotal study conducted to support an FDA premarket approval application (PMAA). The study evaluated the safety and efficacy of the ProACT Adjustable Continence Therapy for the treatment of post-prostatectomy stress urinary incontinence (SUI). The clinical study involved 11 clinical sites and enrolled 160 subjects, all male. A total of 124 subjects met study criteria and 123 were implanted with ProACT. Baseline and outcomes for 68 patients who completed 4-year follow-up visits are reported. Endpoints included 24-h pad weight, Incontinence Quality of Life Questionnaire (I-QOL), UCLA Prostate Cancer Index-Urinary Function (PCI-UF), residual volume, and incidence and severity of device or procedure-related adverse events. Statistically significant improvements during follow-up were observed in 24-h pad weight, for which the mean pre-implant urine loss was 293 g, which was reduced at 4 years to 73 g (P < 0.001). Reductions in pad weight were observed across all levels of pre-implant SUI severity. Significant improvements were also seen in quality of life as measured by the I-QOL (P < 0.001) as well as measures of urinary function and pad use. One procedure-related SAE (retention) was reported among the 68 subjects; the SAE was resolved without clinical meaningful sequalae. These results confirm the long-term safety and efficacy of this newly FDA-approved therapy, showing significant improvements in both objective and subjective measures of SUI in mild, moderate, and severely incontinent male patients. The implant procedure is minimally invasive, and complications are generally mild and easily resolvable.

Treatment with an adjustable long-term implant for post-prostatectomy stress incontinence: The ProACT™ pivotal trial.

This paper presents 18-month follow-up results for patients enrolled in a pivotal study conducted to support an FDA premarket approval application (PMAA). The trial evaluated the safety and efficacy of the ProACT Adjustable Continence Therapy for the treatment of post-prostatectomy stress urinary incontinence (SUI). The clinical study involved 11 clinical sites and enrolled 160 subjects. A total of 124 subjects met study criteria and 123 underwent ProACT implantation from July 2005 through June 2007, of whom 98 completed 18-month follow-up. Endpoints included 24-h pad weight, Incontinence Quality of Life Questionnaire (I-QOL), UCLA Prostate Cancer Index-Urinary Function (PCI-UF), residual volume, and device or procedure-related adverse events (AEs). The mean surgical time was 32 min. Statistically significant improvements during follow-up were observed in 24-h pad weight, for which the cohort mean pre-implant urine loss was 399 g, which was reduced at 18 months to 160 g (P < 0.001). Reductions in pad weight were observed across all levels of pre-implant SUI severity. Significant improvements were also seen in quality of life as measured by the I-QOL (P < 0.001) as well as measures of urinary function and pad count. One procedure-related serious adverse event (SAE), retention, was reported among the 124 subjects; the SAE was resolved without clinical meaningful sequalae. These results demonstrate the safety and efficacy of this newly FDA-approved therapy, showing significant improvements in objective and subjective measures of SUI in mild, moderate, and severely incontinent male patients. The duration of the implant procedure is short, and complications are mild and easily resolvable.

Short-term Uresta efficacy (SURE) study: a randomized controlled trial of the Uresta continence device.

An intravaginal device (Uresta) is currently available for the treatment of stress urinary incontinence (SUI). Case-series data on its effectiveness exist; however, controlled data are lacking. The objective of this study is to determine the short-term efficacy of the Uresta device using a randomized placebo controlled trial. The hypothesis is that the Uresta device might significantly reduce urinary loss. A single blind randomized controlled trial was conducted among women with urodynamic SUI recruited from a single urogynecology unit. Participants were randomized to receive the Uresta device or a placebo vaginal silastic ring placed high in the vagina for the duration of a pad test. Pad tests were performed before and after device placement. The primary outcome was the achievement of a 50% or greater reduction in pad weight after device placement, in a comparison of the two groups. Sample size calculation showed a need for 18 subjects per group. Fisher's exact test was used to analyze the primary outcome. Research Ethics Board approval was obtained. Eighteen subjects per group completed the study protocol. The percentage of patients who achieved the primary outcome was 66.7% in the Uresta group and 22.2% in the placebo group (p = 0.01). The baseline demographic data were similar in the two groups. There were no adverse events during the test period. The Uresta intravaginal continence device significantly reduces the short-term objective measures of urine loss due to SUI. Further study to assess subjective outcomes and long-term patient satisfaction is required.

Pelvic Floor Muscle Training With and Without Electrical Stimulation in the Treatment of Lower Urinary Tract Symptoms in Women With Multiple Sclerosis.

The aim of this study was to evaluate the effect of intravaginal neuromuscular electrical stimulation (NMES) and transcutaneous tibial nerve stimulation (TTNS) on lower urinary tract symptoms (LUTS) and health-related quality of life in women undergoing pelvic floor muscle (PFM) training (PFMT) with multiple sclerosis (MS) and to compare the efficacy of these 2 approaches. Randomized controlled trial. Thirty women with MS and LUTS were randomly allocated to 1 of 3 groups and received treatment for 12 weeks. Ten women in group 1 received PFMT with electromyographic (EMG) biofeedback and sham NMES. Ten women in group 2 underwent PFMT with EMG biofeedback and intravaginal NMES, and 10 subjects in group 3 received PFMT with EMG biofeedback and TTNS. Multiple assessments, performed before and after treatment, included a 24-hour pad test, 3-day bladder diary, assessment of PFM function (strength and muscle tone), urodynamic studies, and validated questionnaires including Overactive Bladder Questionnaire (OAB-V8), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and Qualiveen instrument. All groups showed reductions in pad weight, frequency of urgency and urge urinary incontinence episodes, improvement in all domains of the PFM assessment, and lower scores on the OAB-V8 and ICIQ-SF questionnaires following treatment. Subjects in group 2 achieved significantly greater improvement in PFM tone, flexibility, ability to relax PFMs, and OAB-V8 scores when compared to subjects in groups 1 and 3. Results suggest that PFMT alone or in combination with intravaginal NMES or TTNS is effective in the treatment of LUTS in patients with MS. The combination of PFMT and NMES offers some advantage in the reduction of PFM tone and symptoms of overactive bladder.

Urolastic for the treatment of women with stress urinary incontinence: 24-month follow-up.

IntroductionTo evaluate the efficacy and durability of Urolastic, a new urethral bulking agent in women with stress urinary incontinence (SUI), after a follow-up of 24-months.Material and methodsA follow-up study of women with SUI who received a Urolastic injection and successfully passed the 12-month follow-up. Assessment included the Stamey Grade, 1-h Pad weight test, and the International quality of life (I-QoL) score.ResultsNineteen women who completed the 12-month follow-up were invited for the 24-month follow-up study. One patient did not respond to the correspondence. Four of the 18 patients who responded to the correspondence reported removal of the Urolastic implant at another facility, based on their desire. The explanation for this removal was painful intercourse (n = 1) or less than optimal dryness (n = 3). The overall objective improvement in continence status at 24-months was 66% compared to the 89% at the 12-month follow-up, while in addition the 1-h pad weight test showed >50% reduction in pad weight in 66% of patients compared to 84% at the 12-month follow-up. Adverse events reported were urinary tract infection (n = 1), local genital infection with erosion into the vagina (n = 1), painful intercourse (n = 2), and urgency (n = 4).ConclusionsUrolastic is comparable to other bulking agents in terms of durability, efficacy, and complications.

The Safety and Efficacy of a New Adjustable Single Incision Sling for Female Stress Urinary Incontinence

We describe the safety and efficacy of the Altis(®) Single Incision Sling System for the treatment of female stress urinary incontinence through 12months. In this study we collected a variety of safety and efficacy measures relevant to the assessment of urinary incontinence. The primary efficacy end point was improvement in 24-hour pad weight test. Other efficacy measures included the cough stress test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, Patient Global Impression of Improvement and 3-day voiding diary. Safety was evaluated through assessment of device and procedure related adverse events. Of 116 surgical attempts 113 subjects were implanted with the Altis sling. Of these patients 103 had primary efficacy data at baseline and 6 months, and 101 had efficacy data at baseline and 12 months. Consequently 88 (85.4%) subjects at 6 months and 91 (90.1%) at 12 months achieved a 50% or greater reduction in pad weight. The cough stress test was negative for 95 (92.2%) subjects at 6 months and 91 (90.1%) at 12 months. A decrease in median leaks per day was observed at 6 months and improvements in all patient reported measures were observed through 12 months. A majority of subjects reported feeling much better or very much better at 6 and 12 months, respectively. There were no reports of mesh erosion or migration and no unanticipated adverse events through 12 months. The Altis sling appears to be safe and efficacious, and performs asintended in the treatment of stress urinary incontinence through 12 months.

Urolastic—A New Bulking Agent for the Treatment of Women with Stress Urinary Incontinence: Outcome of 12 Months Follow Up

Objective. To evaluate the efficacy and safety of the new injectable implant, Urolastic, in women with stress urinary incontinence (SUI) after 12-month followup. Materials and Methods. A prospective, cohort study included adult women with SUI. Patients were treated with Urolastic periurethral injections under local anaesthesia. The injection procedure was repeated after 6 weeks when indicated. Patients were evaluated for efficacy and safety parameters 6 weeks, 3 months, and 12 months after therapy. Results. Twenty women 56 (33–71) years old were included. Thirteen patients (65%) received one injection each (overall average of 2,1 mL); 7 patients (35%) received a second injection. Nineteen patients complete the 12-month followup. The mean Stamey incontinence grade significantly decreased from 1.9 at baseline to 0.4 at 12 months (visit IV) (P < 0.001). None of the patients were dry at baseline; 68% of them were dry at 12 months. The mean number of incontinence episodes significantly decreased from 6/day at baseline to 1.6/day at visit IV (P < 0.001). Reduction in pad weight went from 20.2 to 7.8 g at one year. The mean I-QoL score significantly increased from 51 at baseline to 76 at visit IV (P < 0.001). Six patients (30%) developed minor complications related to the injection procedure. Conclusions. Urolastic is effective and long-standing urethral bulking agent with moderate adverse events.

Pelvic floor muscle training using an extracorporeal biofeedback device for female stress urinary incontinence

Extracorporeal biofeedback was developed to reduce patient discomfort when performing strengthening exercises. The efficacy and safety of extracorporeal biofeedback combined with pelvic floor muscle training (PFMT) for the treatment of female stress urinary incontinence (SUI) were evaluated. One hundred and six participants with SUI were enrolled in a 12-week PFMT program using extracorporeal biofeedback intervention. A standard pad test was performed, and pelvic floor muscle strength was assessed using the Oxford scale. Measurements were taken with a perineometer at baseline and at a 12-week follow-up visit. An objective cure was defined as less than 2 g of urine leakage by the standard pad test. The long-term effects of extracorporeal biofeedback and PFMT were investigated by interviewing the participants 12 months after treatment. Seventy-one participants completed the 12-week extracorporeal biofeedback intervention. The objective cure rate was 52.1 %, and there was a significant reduction in pad weight over the time period. The incontinence visual analogue scale, the Sandvik severity index, and the incontinence quality-of-life questionnaire domains were significantly improved after treatment (p<0.001). The strength of the PFM was significantly increased after the 12-week treatment. After PFMT, 64.3 % of 56 participants reported good treatment compliance, and 24 participants (42.9 %) had continued PFMT at home 12 months after treatment. Age and baseline pad weight were negative predictive factors for an objective cure of SUI. Pelvic floor muscle training using extracorporeal biofeedback can be an effective and safe conservative treatment option for female SUI without the discomfort caused by vaginal sensors.

Patient-adjusted intermittent electrostimulation for treating stress and urge urinary incontinence.

To assess the safety and efficacy of pelvic floor muscle electrostimulation (ES) in women with stress urinary incontinence (SUI) or mixed UI (MUI, urge and interstitial cystitis), using a new portable electrostimulator (Miniaturo, Biocontrol Medical Inc., Yehud, Israel) which delivers different forms of stimulation for treating these two conditions. For SUI the stimulator is activated on demand only by a sudden increase in intra-abdominal pressure; for frequency and urgency a milder, continuous ES is used. The intensity of ES can be adjusted according to the patient's sensation. Women were enrolled into the study after satisfying inclusion criteria and pad testing; 23 participated in two study groups, i.e. 16 with SUI and seven with MUI (severe frequency, urgency and urge, and mild SUI). The pelvic floor muscles were stimulated through an electrode inserted paraurethrally, positioned similarly in all patients. In patients with SUI and MUI a pressure sensor was also inserted into the rectum, to record intra-abdominal pressure. Stimulation was applied for 1-4 h in patients with SUI and for 6 h in those with MUI. The evaluation was based on urinary symptoms (frequency, urgency, leaking episodes), quality-of-life questionnaires and pad tests at baseline and during stimulation. All patients in both groups improved significantly; of the 16 patients with SUI, nine were completely dry during ES, and the remaining seven had a reduced mean pad weight, from 23 to 6 g (74%). There was no significant reduction in pad weight after sham ES (17 g before vs 24.2 g after). In four patients with SUI who continued ES for 4 h the mean cumulative stimulation time (calculated from the stimulator memory) was 3 min (1.3% of 4 h). In the MUI group there were no leakage episodes during ES and significant reductions in voiding variables (Student's t-test) in all. The mean (Sd) voiding frequency, urinary urgency and leaking episodes decreased from 8.1 (4.2) to 1.9 (1.5), 6.4 (2.3) to 0.7 (1.3) and 2.1 (0.7) to 0.7 (0.5) (all P < 0.001), respectively. The concept of this ES system for treating UI is promising; this study supports the efficacy of this form of ES but no conclusions about clinical efficacy are possible at this stage, and thus a trial to evaluate the safety and efficacy of this implantable device is ongoing.