THE JOURNAL OF FEMALE
URINARY INCONTINENCE


Poster Section
 
 

Vaginal Weight Cone versus Assisted Pelvic Floor Muscle Training
in the Treatment of Female Urinary Incontinence.
A Prospective, Single-blind, Randomized Trial

Eliane Hilberath Moreira, Monica Orsi Gameiro,
Felipe Orsi Gameiro, Juliana Cruz Moreno,
Carlos Roberto Padovani , João Luiz Amaro.
Urology Department, Botucatu Medical School,
São Paulo State University
UNESP – Botucatu – Brazil.

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ABSTRACT

Purpose: To compare the efficacy of Vaginal Weight Cone (VWC) and assisted pelvic floor muscle training (APFMT) in the treatment of urinary incontinence (UI) in women.
Material and Methods: 103 women were prospectively studied with a mean age of 48 years (range: 24-70). Patients were randomly distributed, in a single-blinded study, into two groups: Group G1 (n = 51) treated with vaginal weight cones and group G2 (n = 52) APFMT assessment. None of the patients had a urodynamic diagnosis of stress urinary incontinence (SUI). They had been referred by a gynecologist as having symptom of SUI and 50% also presented urge incontinence. This study was approved by the Bioethics Commission of the Paraná State University. The following parameters were performed initially (T0) with follow-up at 6 (T6) and 12 (T12) months: 1) Clinical questionnaire, 2) Visual Analog Scale (VAS) for assessing the degree of bother in wetness and discomfort sensation, and urine stream interruption test, 3) 60-min Pad Test, 4) Subjective evaluation of pelvic floor muscle (PFM) using Transvaginal digital palpation (TDP) , and 5) Objective assessment of PFM using a perineometer (Peritron 9300+, Cardio design, Castle Hill, Australia).
Results: There was no statistically significant difference in demographic data between both groups. A significant decrease in nocturia and urgency was observed after treatment in both groups at 6 and 12 months (p< 0.05). There was significant improvement in subjective evaluation of urine loss in both groups at 6 and 12 months (p<0.05). There was no statistical difference between groups. In VAS, after 6 and 12 months there was a significant improvement in wetness sensation in both groups (p< 0.05). However, in G1, the patients reported to be significantly drier after 6 months (p< 0.05). In discomfort sensation, there was a significant improvement in both groups at 6 and 12 months (p< 0.05).  There was a significant higher capacity of stream interruption at 6 and 12 months in both groups  (p< 0.05). The 60 miutes Pad Test showed significant reduction of the pad weight at 6 and 12 months in both groups (p< 0.05), no statistical difference was observed between groups. Subjective and objective evaluation of PFM showed significant improvement of muscle strength in both groups at 6 and 12 months (p< 0.05). However, in objective assessment, the improvement in G1 was significantly higher than G2 at 6 months.
Conclusion: The use of vaginal weight cone and assisted PFMT were both effective in the treatment of urinary incontinence in women.

Key words: Urinary incontinence; Conservative management; vaginal weight cone; assisted PFME.
 
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INTRODUCTION
 

Many factors may be involved in the ethiopathogeny of urinary incontinence (UI) in women and their comprehension has allowed more satisfactory therapeutic results to be achieved. Several authors have studied the benefits of pelvic floor muscles training (PFMT) on the treatment of UI1,2,3.
Vaginal weight cones (VWC) may be used in pelvic floor muscles (PFM) rehabilitation4, acting through recruitment of muscle fibers types I and II and may help patients to become conscious of perineal muscle action, with consequent rise in PFM strength5. Favorable results of treatment of stress urinary incontinence (SUI) with vaginal cones vary from 60% to 80% of the cases5,6.
In a comparative study of VWC versus perineal exercises, there was 80% of subjective improvement of urinary loss in the vaginal cone group, whereas only 60% improved in perineal exercises group6. Additionally, the period of time for learning the perineal exercises was three times longer than that for vaginal cones6. Another study showed significantly higher improvement of the pelvic floor strength with vaginal cones, when compared to perineal exercises7. On the other hand, posteriorly it was demonstrated better strengthening of the PFM, as well as improvement of urinary loss, with assisted PFMT8.
Controversy still exists in the literature regarding the best conservative treatment modality for UI. The objective of this study was to compare the efficacy of the VWC and assisted PFMT to treating UI in women8.
Existe ainda controvérsias na literatura do melhor tipo de tratamento conservador para IU.   Este estudo tem por objetivo comparar a eficácia da utilização de cone vaginal comparado aos exercícios perineais supervisionados no tratamento da IUE.



MATERIAL AND METHODS
 

103 incontinent women were studied in a prospective trial. To be eligible, patients had been referred by a gynecologist as having symptom of predominant SUI and 50% also presented urge incontinence. None of the patients had a urodynamic diagnosis of SUI. None of the patients had taken anticholinergics or tricyclic antidepressants, or had been treated using pelvic floor exercises or bladder training.
Base on outcome measurements with no numerical variable (including patient’s perception of improvement, wetness, and discomfort sensation, and subjective evaluation of perineal muscle strength), the statistical test needed to compare groups of equal size. The total sample size had previously been established as at least 40 women.
Patients were randomly distributed, in a single-blind study, into two groups. Group G1 (n=51) were submitted to VWC associated to standardized general exercise, which aimed to increase abdominal pressure and consequently to improve the effectiveness of this treatment. In group G2 (n=52) to assisted PFMT. The protocols consisted of one 40-min session per week over a 12-week period. All patients were evaluated initially (T0), with follow-up at 6 (T6) and 12 (T12) months by the same investigator. The average age in G1 was 49 years, and in G2 48 years (p> 0.05).
All patients were informed about the procedures and study objectives and provided written consent, as approved by the Ethics Committee of the Hospital Universitário Regional do Norte do Paraná.
Exclusion criteria were: anterior or posterior vaginal prolapse beyond grade II9,  urinary infection, neurological or demielinizing condition and poor comprehension.
The following parameters were performed initially (T0) with follow-up at 6 (T6) and 12 (T12) months: 1) Clinical questionnaire, 2) Visual Analog Scale (VAS) for assessing the degree of bother in wetness and discomfort sensation, and urine stream interruption test, 3) 60-min Pad Test, 4) Subjective evaluation of pelvic floor muscle (PFM) using Transvaginal digital palpation (TDP) , and 5) Objective assessment of PFM using a perineometer (Peritron 9300+, Cardio design, Castle Hill, Australia).
A clinical questionnaire was used to obtain personal data and history, daily micturition, and subjective analysis of urine loss. Body mass index was calculated according to Garrow10.
A visual analogue scale (VAS) was used to assess the bother degree of wetness and discomfort sensation, and also to evaluate the capacity of patients to interrupt the urine stream (Figure 1). 
Objective urine loss was evaluated by 60-min pad test.
Subjective assessment of PFM consisted transvaginal digital palpation (TDP). The subjects were in a supine position with a pillow under their head, with their knees straight and legs abducted. The PFM contraction was graded according to muscle force against examinerrsquos fingers (Table 1).
Objective evaluation of perineal muscle strength was made using a portable perineometer (Peritron 9300+, Cardio Design, Castle Hill, Australia) connected to a balloon catheter, sized 11×2.6 cm, inserted into the vagina. The balloon should be 1 cm from the outside of the vaginal conduit. In this way the middle of the balloon was placed 3.5 cm inside the vaginal introitus (Figure 2). Measurements of maximum and mean squeeze pressure, and holding period in seconds, were assessed in the supine position. Only contractions with simultaneously visible inward movement of the perineum were accepted as correct.For statistical analysis the Goodman test was used to compare the different variables and the Student´s t test12 for independent samples. Differences was considered significant when the p value was <0.05.

 
RESULTS
 

There were no statistically significant differences in the demographic data of both groups.
The use proportional of pads after treatment was reduced significantly in both groups. However, this reduction was significantly higher in group G1, at 6 and 12 months (Figure 3).
Average number of micturitions in 24h was 6.6, in G1, and 6.3, in G2, no statistical difference between groups in different moments.
There was a significant improvement in urgency perception and subjective evaluation of urine loss at 6 and 12 months, there was no difference between groups (p>0.05).
There was a significant reduction in the number of  nocturia in both groups at 6 and 12 months. No statistical difference was observed between the groups in different moments.  
In subjective evaluation of urinary loss observed a significant improvement at 6 and 12 months, here was no difference between groups in different moments (p>0.05).
In VAS, there was a significant improvement in the dry perception in T6, more prominently in G1, which was maintained  at 12 months, there was no statistical difference between groups at 12 months (figure 4).
In patient discomfort there was a significant improvement during daily activities  and also a higher capacity to interrupt the urinary stream at T6 and T12. There was no difference between both groups.
In the objective evaluation of urinary loss using 60-min pad test, there was a significant improvement at 6 and 12 months after the treatment. There was no statistical difference between groups in different moments.
There was no statistical difference between groups, in the subjective evaluation of the PFM.
The perineometer evaluation of PFM strength showed significant improvement in both groups, significantly higher in G1 at 6 months. In T12, there was no statistical difference between the groups (Figures 5 and 6). However, there was no statistical difference in the duration of PFM contraction in both groups in different moments (Figure 7).

 
CONCLUSION
 
The use of vaginal weight cone and assisted PFMT were both effective in the treatment of urinary incontinence in women.
 
 
 
 
 

REFERENCES

     

    1. BUMP, R.C., HUNT, G.W., FANT, A. et al. Assessment of Kengel pelvic muscle exercise performance after brief verbal instruction. AM. J. Obstet. Gynecol., v.165, p.322-9, 1991.
    1. WALL, L.L., DAVIDSON, T.G. The role of muscular re-education by physical therapy in the treatment of genuine stress urinary incontinence. Obstet. Gynecol. Surv., v.47, p.322-31, 1992.
    1. HOLLEY, R.L., VARNER, E.R., KERNS, D.J. et al. Long term failure of pelvic floor musculature exercises in treatment of genuine stress incontinence. South Med. J., v.88, p.547-9, 1995.
    2. PLEVNIK, S. New methods for testing and strengthening the pelvic floor muscles. In: ANNUAL MEETING OF THE INTERNATIONAL CONTINENCE SOCIETY, 15, 1985, London. Proceedings… London: International continence society, 1985, p.267-8.
    1. SCHUBLER, B. pelvic floor reeducation: principles and practise. Int. Urogynecol. J., v.10, p.93-8, 1994.
    1. PEATTIE, A.B., PLEVNIK, S., STATION, S.L. Vaginal cones: a conservative method of treating genuine stress incontinence. Br. J. Obstet. Gynecol., v.95, p.1049-53, 1988.
    1. JONASSON, A., LARSSON, B., PSCHERA, H. testing and training of the pelvic floor muscles after childbirth. Acta Obstet. Gynecol. Scand., v.68, p.301-4, 1989.
    1. BO, K., TALSETH, T., HOLME, I. Single blind, randomized controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. Br. Med. J., v.318, p.487-93, 1999.
    1. HALBE, H. W. Tratado de Ginecologia 2ª ed. vol. I, São Paulo: Roca, 1993.
    1. GARROW, J.S. Treatment of obesity. Lancet, v.340 p.409-13, 1992.
    1. LAYCOCK, J., GREEN R.J. Interferential therapy in the treatment of incontinence. Phisiotherapy, v.74, p.161-8, 1988.
    2. TREINER, D.L., NORMAN, G.R. Bioestatistics e base essentials. St. Louis: Mosby Year Book, 1994, 260 p.
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Figures
 
Figure 1 - Visual Analogue Scale (VAS)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Figure 2 -
Position of the balloon catheter inside the vaginal conduit during
objective evaluation of pelvic floor muscular strength by perineometer.
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Figure 3 -
Proportion of pads number in both groups (G1, VWC; G2, Assisted PFMT) pre- treatment (T0), after treatment 6 (T6) and 12 (T12) months.
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Figure 4 -
Proportion of dry perception in both groups (G1, VWC; G2, Assisted PFMT) pre treatment (T0), 6 (T6) and 12 (T12) months after treatment.
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Figure 5 -
Maximum peak of PFM contraction (cmH2O) using perineometer in
both groups (G1, vaginal cone; G2, supervised perineal exercises) pretreatment (M0),
6 months after treatment (M6) and 12 months after treatment (M12).
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Figure 6 -
Average mean peak of PFM contraction (cmH2O) in both groups (G1, VWC; G2, assisted PFMT) pre treatment (M0), at 6 (T6) and 12 (T12) months after treatment.
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Figure 7 -
Duration of PFM contraction (seconds) in both groups (G1, VWC; G2, assisted PFMT) pre treatment (T0), at 6 (T6) and 12 (T12) months after treatment .
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