The conservative management of patients with symptoms of stress incontinence: a randomized, prospective study comparing weighted vaginal cones and interferential therapy. Single-blind, randomized, controlled trial of pelvic floor muscle training, electrical stimulation, vaginal cones, and no active treatment in the management of stress urinary incontinence. Pelvic floor exercises versus vaginal weight cones in genuine stress incontinence. A randomized controlled trial of the effectiveness of pelvic floor therapies for urodynamic stress and mixed incontinence. A randomized prospective study comparing new vaginal cone and FES-Biofeedback. Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. Stress incontinence surgery for patients presenting with mixed incontinence and a normal cystometrogram. Tension free vaginal tape versus Burch colposuspension for treatment of female stress urinary incontinence. A randomized controlled trial of duloxetine alone, pelvic floor muscle training alone, combined treatment and no active treatment in women with stress urinary incontinence.
Sixty-nine female patients with symptoms of stress urinary incontinence were randomized to treatment with either interferential therapy or weighted vaginal cones. Fifty-four patients completed treatment (interferential therapy, 30 patients; weighted vaginal cones, 24 patients). Patients were assessed by subjective response, pad testing, continence charts, and the maximum weight of cone that could be held actively and passively. Forty-seven patients were reassessed at 6 months (19 cones; 28 interferential), five patients (9.26%) required surgery, and two patients (3.7%) could not be reassessed. Subjective response to treatment was good, with 80% to 90% of patients cured or improved after treatment. After 6 months, 41.67% in the cone group and 40% in the interferential group were subjectively cured, with improvement in 50% and 30%, respectively. Of those patients initially referred for treatment, greater than 30% in each group were cured of symptoms. There was an objective improvement in both groups. In the cone group 50% had improved after treatment and greater than 60% had improved at 6 months as assessed by pad testing, while in the interferential group 76% had improved after treatment and 73% had improved at 6 months. There was no significant difference in improvement between the two groups in any of the methods of assessment. However, the cones require less supervision by trained staff and can be used at home by the patient. Their use results in a savings in time for the physiotherapy department. The use of the cones is recommended as a cost-effective method of treatment that can be added to the present therapy options available to the physiotherapist. To compare the effectiveness of pelvic floor exercises, electrical stimulation, vaginal cones, and no active treatment in women with urodynamic stress urinary incontinence.
                One hundred eighteen subjects were randomly selected to receive pelvic floor exercises (n=31), ES (n=30), vaginal cones (n=27), or no treatment (untreated control) (n=30). Women were evaluated before and after completion of six months of treatment by the pad test, quality of life questionnaire (I-QOL), urodynamic test, voiding diary, and subjective response.
                In the objective evaluation, we observed a statistically significant reduction in the pad test (p=0.003), in the number of stress urinary episodes (p<0.001), and a significant improvement in the quality of life (p<0.001) in subjects who used pelvic floor exercises, electrical stimulation, and vaginal cones compared to the control group. No significant difference was found between groups in the urodynamic parameters. In the subjective evaluation, 58%, 55%, and 54% of women who had used pelvic floor exercises, electrical stimulation, and vaginal cones, respectively, reported being satisfied after treatment. In the control group, only 21% patients were satisfied with the treatment.
                Based on this study, pelvic floor exercises, electrical stimulation, and vaginal cones are equally effective treatments and are far superior to no treatment in women with urodynamic stress urinary incontinence. To compare pelvic floor exercises and vaginal weight cones in the treatment of genuine stress incontinence.
                Randomised controlled trial.
                Sixty ambulatory and fit white women (mean age 56 years) with urinary stress incontinence, treated by a single physiotherapist as outpatients during twelve weeks. Thirty women were allocated to a weekly session of pelvic floor exercises. Thirty were allocated to using cones, they were seen every two weeks.
                Objective: stress test, vaginal squeezing capacity. Subjective: urinary diary, visual analogue scales.
                Characteristics of both study groups were comparable. Unfortunately, there was an early withdrawal of fourteen (47%) women in the group treated with cones, and none in the other group. Therefore the pelvic floor exercise group was compared not only with the group intended to be treated with cones, but also with the selected group that only received cone therapy. No statistically significantly differences in outcome measures were found between the groups: 53% in the group assigned to pelvic floor exercises and 57% into the group assigned to cones, of which 50% in the group actually treated with cones, considered themselves as cured or improved to a significant degree. Long-term follow-up was not possible as all cone users refused continued exercises with cones once the twelve weeks had ended.
                Pelvic floor exercises and cones are equally effective in the treatment of genuine stress incontinence. Cones are cost and time saving. However, the low patient compliance with the cones importantly limits its clinical applicability, especially in the long run. Therefore, we do not recommend the use of cones. To assess the efficacy and cost-effectiveness of pelvic floor muscle therapies (PFMT) in women aged > or = 40 years with urodynamic stress incontinence (USI) and mixed UI.
                In a three-arm randomized controlled trial in Leicestershire and Rutland UK, 238 community-dwelling women aged > or = 40 years with USI in whom previous primary behavioural intervention had failed were randomized to receive either intensive PFMT (79), vaginal cone therapy (80) or to continue with primary behavioural intervention (79) for 3 months. The main outcome measure was the frequency of primary UI episodes, and secondary measures were pad-test urine loss, patient perception of problem, assessment of PF function, voiding frequency, and pad usage. Validated scales for urinary dysfunction, and impact on quality of life and satisfaction were collected at an independent interview.
                All three groups had a moderate reduction in UI episodes after intervention but there was no statistically significant difference among the groups. There were marginal improvements in voiding frequency for all groups, with no statistically significant difference among them.
                In women who have already had simple behavioural therapies (including advice on PFM exercises) for urinary dysfunction, the continuation of these behavioural therapies can lead to further improvement. The addition of vaginal cone therapy or intensive PFMT does not seem to contribute to further improvement. The improvement in pelvic floor function was significantly greater in the PFMT arm than in the control arm although this did not translate into changes in urinary symptoms. Several different methods of enhancing pelvic floor functions have been developed and modified. The aim of this study was to compare the efficacy of a new vaginal cone with conventional FES-Biofeedback therapy for female urinary incontinence, with respect to pelvic floor rehabilitation. One hundred and twenty patients, who required a non-surgical treatment for urinary incontinence, were divided randomly into two groups; (1) the Functional Electrical Stimulation (FES)- Biofeedback group (or BFB group) and (2) the new vaginal cone group (or cone group). For a period of six weeks, two training sessions each week were carried out on the BFB group. The new 150-gram dumbbell-shaped vaginal cone, made of fine ceramic material, was developed domestically. A therapist instructed patients in the cone group upon its use for pelvic floor exercise, and directed the exercise to be repeated at home daily; these patients had follow-up visits every week. Objective improvements were obvious in both groups. 88.3% and 91.6% of the cone and BFB groups showed an improvement after treatment, respectively. There was no significant difference in the improvement or dissatisfaction scores of the two groups. In conclusion, no significant differences in the therapeutic effects were observed between the FES- Biofeedback and the new vaginal cone groups. Considering improvements in the quality of life and objective symptoms, the therapeutic effects of the two techniques showed no significant differences. The new vaginal cone is relatively easy to use at home and aids in pelvic floor muscle exercises. Consequently, the new vaginal cone could be used as an alternative non-surgical treatment modality in female stress urinary incontinence. To compare the effect of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment for genuine stress incontinence.
                Stratified, single blind, randomised controlled trial.
                Multicentre.
                107 women with clinically and urodynamically proved genuine stress incontinence. Mean (range) age was 49.5 (24-70) years, and mean (range) duration of symptoms 10.8 (1-45) years.
                Pelvic floor exercise (n=25) comprised 8-12 contractions 3 times a day and exercise in groups with skilled physical therapists once a week. The electrical stimulation group (n=25) used vaginal intermittent stimulation with the MS 106 Twin at 50 Hz 30 minutes a day. The vaginal cones group (n=27) used cones for 20 minutes a day. The untreated control group (n=30) was offered the use of a continence guard. Muscle strength was measured by vaginal squeeze pressure once a month.
                Pad test with standardised bladder volume, and self report of severity.
                Improvement in muscle strength was significantly greater (P=0.03) after pelvic floor exercises (11.0 cm H2O (95% confidence interval 7.7 to 14.3) before v 19.2 cm H2O (15.3 to 23.1) after) than either electrical stimulation (14.8 cm H2O (10. 9 to 18.7) v 18.6 cm H2O (13.3 to 23.9)) or vaginal cones (11.8 cm H2O (8.5 to 15.1) v 15.4 cm H2O (11.1 to 19.7)). Reduction in leakage on pad test was greater in the exercise group (-30.2 g; -43. 3 to 16.9) than in the electrical stimulation group (-7.4 g; -20.9 to 6.1) and the vaginal cones group (-14.7 g; -27.6 to -1.8). On completion of the trial one participant in the control group, 14 in the pelvic floor exercise group, three in the electrical stimulation group, and two in the vaginal cones group no longer considered themselves as having a problem. Conclusion: Training of the pelvic floor muscles is superior to electrical stimulation and vaginal cones in the treatment of genuine stress incontinence. To evaluate the outcome of surgery for stress urinary incontinence (SUI) in patients presenting with a combination of stress and sensory urge UI.
                The study comprised 75 women presenting with mixed incontinence; the most important inclusion criterion was a negative cystometrogram for detrusor overactivity. Based on random selection, a third of the patients received a 6-month course of anticholinergic treatment (group 1) and 50 (group 2) had surgery for SUI. The surgical procedure depended on the Valsalva leak-point pressure (VLPP); those with a VLPP of > or = 90 cmH2O underwent Burch retropubic bladder neck suspension (group 2a, 24 patients) while 26 (group 2b) with a VLPP of < 90 cmH2O had pubovaginal sling (PVS) surgery. A further group of 20 patients with pure SUI (no urge UI) underwent surgery (PVS in 12 and Burch in eight) as a control group (group 3). After at least 6 months of follow-up (mean 9.3, sd 1.7), 68 patients were evaluable; they were assessed subjectively and objectively for dryness, and by a urodynamic evaluation and quantitative assessment using the SEAPI scoring system.
                In group 1 none of the patients became completely dry; there was persistent stress with and without urge UI in nine (43%) and 12 (57%) of the available 21 patients, respectively. Only three of those who had persistent SUI with no urge in the whole study group were satisfied and chose to continue anticholinergic therapy despite SUI. In this group the mean (sd) improvement in the subjective and objective SEAPI score was 3.4 (1.0) and 2.3 (3.8), respectively. In group 2a, 20 of the available 23 patients (87%) became completely dry (both stress and urge continent). The mean improvement in the SEAPI scores was 7.8 (0.9) and 7.8 (1.3), respectively. In group 2b, 20 of the 24 patients (83%) became completely dry, with mean improvements in SEAPI scores of 8.2 (0.4) and 7.9 (0.3), respectively. The improvement was statistically significant after surgery, vs anticholinergic therapy, for all variables (P < 0.05). The incidence of persistent urge UI was highest in group 1 (43%), being 13% in group 2 (13% and 12% in 2a and b, respectively). In group 3 there was de novo urge UI in four of the 20 patients, and not significantly different from that in group 2.
                Most patients with mixed stress and urge UI and a normal cystometrogram were cured of both symptoms by surgery. The incidence of residual urge in such patients was no higher than that of de novo urge after surgery in patients with genuine SUI. Many surgical procedures have been proposed for treatment of stress urinary incontinence (SUI) but none of them has proved completely successful. The aim of this study is to compare the efficacy and safety of tension free vaginal tape (TVT) with Burch colposuspension in the treatment of SIU.
                Fifty female patients, presenting with SUI were randomly divided into two equal groups. SUI was confirmed using urodynamic study in all patients. Group 1 (n=25) patients underwent Burch colposuspension while Group 2 (n=25) underwent TVT. Patients with high grade cystocele, previous surgical failure for SUI, uninhibited detrusor contraction during bladder filling on urodynamic study and incompetent internal sphincters were excluded from this study. A patient was declared cured of SUI, if 3-6 months after surgery she had no SUI. The procedure was judged to be a failure if 3-6 months after surgery, patient had SUI.
                In group 1 patients, 72% were completely cured, 16% improved and 12% showed no improvement. In group 2 patients, 72 were completely cured, 20% improved and only 8% showed no improvement. There was no difference between the two groups in terms of cure rates. Operative time for TVT was significantly less compared to Burch. Postoperative pain was less in TVT than Burch. Return to normal activity was earlier in TVT compared to Burch group. Intra operative perforation of the urinary bladder occurred in 8% of patients in group 2. Urine retention occurred in 12% of patients in group 1 compared to 20% in group 2. This was successfully managed conservatively. De novo urgency developed in 12% in group I and 8% in group II and was successfully managed by medical treatment.
                The success rates of TVT and Burch colposuspension in the treatment of SUI in our experience are very similar. However, TVT is associated with less morbidity. We recommend TVT procedure for females with genuine SUI. We primarily compared the effectiveness of combined pelvic floor muscle training (PFMT) and duloxetine with imitation PFMT and placebo for 12 weeks in women with stress urinary incontinence (SUI). In addition, we compared the effectiveness of combined treatment with single treatments, single treatments with each other and single treatments with no treatment.
                This blinded, doubly controlled, randomized trial enrolled 201 women 18 to 75 years old with SUI at 17 incontinence centers in the Netherlands, United Kingdom and United States. Women averaged 2 or more incontinence episodes daily and were randomized to 1 of 4 combinations of 80 mg duloxetine daily, placebo, PFMT and imitation PFMT, including combined treatment (in 52), no active treatment (in 47), PFMT only (in 50) and duloxetine only (in 52). The primary efficacy measure was incontinence episode frequency. Other efficacy variables included the number of continence pads used and the Incontinence Quality of Life questionnaire score.
                The intent to treat population incontinence episode frequency analysis demonstrated the superiority of duloxetine with or without PFMT compared with no treatment or with PFMT alone. However, pad and Incontinence Quality of Life analyses suggested greater improvement with combined treatment than single treatment. A completer population analysis demonstrated the efficacy of duloxetine with or without PFMT and suggested combined treatment was more effective than either treatment alone.
                The data support significant efficacy of combined PFMT and duloxetine in the treatment of women with SUI. We hypothesize that complementary modes of action of duloxetine and PFMT may result in an additive effect of combined treatment.
This review provides some evidence that weighted vaginal cones are better than no active treatment in women with SUI and may be of similar effectiveness to PFMT and electrostimulation. This conclusion must remain tentative until larger, high-quality studies, that use comparable and relevant outcomes, are completed. Cones could be offered as one treatment option, if women find them acceptable.