The conservative management of patients with symptoms of stress incontinence: a randomized, prospective study comparing weighted vaginal cones and interferential therapy. A randomized prospective study comparing new vaginal cone and FES-Biofeedback. A randomized controlled trial of pelvic floor muscle exercises to treat postnatal urinary incontinence. Pelvic floor exercises versus vaginal weight cones in genuine stress incontinence. Effectiveness of two conservative modes of physical therapy in women with urinary stress incontinence. Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. Pelvic floor reeducation for stress incontinence: comparing three methods. A randomized controlled trial of the effectiveness of pelvic floor therapies for urodynamic stress and mixed 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. 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. A randomized controlled trial was carried out to evaluate the extent to which a program of reinforced pelvic floor muscle exercises (PFME) reduces urinary incontinence 1 year after delivery. Two hundred and thirty women who were incontinent 3 months postpartum were randomized to either a control group doing standard postnatal pelvic floor muscle exercises (n = 117) or to an intervention group (n = 113) who saw a physiotherapist for instruction at approximately 3, 4, 6 and 9 months postpartum. Results collected 12 months after delivery included prevalence and frequency of incontinence and PFME, sexual satisfaction, perineometry measurements and pad tests. Twenty-six (22%) of the control group and 59 (52%) of the intervention group withdrew before the final assessment. The prevalence of incontinence was significantly less in the intervention group than in the control group (50% versus 76%, P=0.0003), and this group also did significantly more PFME. There were no significant differences between the groups as regards sexual satisfaction, perineometry measurements or pad test results. 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. Stress incontinence is the most prevalent form of female urinary incontinence and it affects approximately 5% of younger women to nearly 50% of elderly women. Women have traditionally been treated with pelvic floor muscle exercises alone or with the use of vaginal cones. A new treatment mode, vaginal balls, has been developed. The aim of this study was to compare pelvic floor muscle training with and without vaginal balls and to collect information on women's subjective feelings about the two training modes. The study was carried out as a prospective randomized clinical trial. Thirty-seven women aged 25-65 were assigned either to a pelvic floor muscle training program or to a training program using weighted vaginal balls for 4 months. Treatment outcomes were assessed by a pad-test with a standardized bladder volume, vaginal palpation, and by women's self-reported perceptions. The sense of coherence score was compared with the score for a normal population. Ninety-three percent of the women completed the study. Both training modes were effective in reducing urinary leakage: with vaginal balls (P < 0.0001) and without (P < 0.019); and increasing pelvic floor muscle strength: with vaginal balls (P < 0.0039) and without (P < 0.0002). However, the reduction of urinary leakage after four months of exercise in the training group with vaginal balls was significantly better (P < 0.03) than the results in the group training with pelvic floor muscle exercises alone. The study found the weighted vaginal balls to be a good alternative for training pelvic floor muscles in women with stress urinary incontinence.
                Copyright 2001 Wiley-Liss, Inc. 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. Stress urinary incontinence is a common problem among women of all ages but may resolve with pelvic floor reeducation in many cases. Compliance to a regimen of pelvic floor muscle exercises is poor and many devices have been produced to make exercising these muscles more effective and interesting. This article describes a study in which two such devices -- vaginal cones and pressure biofeedback -- were compared with pelvic floor exercises alone. The results show that there is no statistically significant difference between the three modalities; all treatments produced significant improvement in symptoms and quality of life scores. 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.
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.