A pilot randomised controlled trial of the pelvic toner device in female stress urinary incontinence
Introduction and hypothesis
To determine the feasibility of using the pelvic toner device (PTD) in aiding pelvic floor muscle training (PFMT)
Forty women, aged at least 18 years with symptoms of pure stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence were randomly assigned to standard PFMT (ST group), or to PFMT and additional PTD (PTD group). They were evaluated throughout a treatment period of 16 weeks, and followed up 6 months after the active treatment period, using International Consultation on Incontinence Questionnaires (ICIQ), bladder diaries, and other subjective outcome measures for symptom improvement.
Twenty-four women were randomised to ST and 28 to PTD. Twelve women did not complete therapy and analysis was performed on 19 randomised to ST and 21 randomised to PTD on a per protocol basis. The two groups showed statistically significant symptom improvement in ICIQ responses, both at 16 weeks and at 6 months. There was no significant difference between the groups regarding improvement in SUI (ST 52.6 %, PTD 52.4 %) at 16 weeks. At 6 months after the active treatment period, 60 % of women (50 %, 8 in the PTD group and 71.4 %, 10 in the ST group) were still doing pelvic floor exercises. The sample difference observed was not statistically significant. Some women reported that the device helped with confidence that the correct muscles were being contracted, and helped motivation to sustain PFMT.
This pilot study demonstrates the feasibility of PTD for aiding PFMT. It is a safe and well-tolerated adjunct in PFMT, which increases patient choice.
KeywordsIntra-vaginal resistance device Pelvic floor exercises Pelvic floor muscle training Randomised controlled trial Stress urinary incontinence Urinary incontinence
Urinary incontinence, though not life threatening, can be very distressing, with significant physical, psychological, economic, and social implications for the well-being of affected individuals. The estimated prevalence of urinary incontinence in middle-aged and older women ranges between 25 % and 45 % (increasing with age), with approximately half of these women being classified as having stress urinary incontinence (SUI) . Pelvic floor muscle training (PFMT) was first advocated as a treatment for SUI in the 1950s following Arnold Kegel’s reports of an 84 % associated cure rate . Subsequent research has endorsed these findings, demonstrating that women with SUI who carry out PFMT are more likely to report cure or improvement and fewer leakage episodes per day than controls .
In its guideline for the management of female urinary incontinence , the UK National Institute for Health and Clinical Excellence (NICE) recommended PFMT as a safe and effective first-line treatment for women with stress or mixed urinary incontinence. PFMT typically involves helping the woman to confidently identify her pelvic floor and then carry out a self-administered regime of un-resisted pelvic floor contractions according to a provided schedule. Explicitly, unsupervised use of pelvic floor exercises is less effective than PFMT taught by a suitable trainer, with proper assessment that pelvic floor contraction is successfully being achieved, followed by a conscientious regime of regular exercises over a period of several months. Success rates are lower if formal teaching is not provided, or if PFMT is not consistently undertaken over a sustained period . Adjunctive measures such as electrical stimulation , weighted vaginal cones , and biofeedback , which focus on overcoming some of these issues, are not universally advocated as they have yet to produce sufficient evidence of efficacy.
Lack of confidence in successfully identifying the pelvic floor muscles.
Compliance issues associated with the requirement to commit to a daily regime of pelvic floor exercises in the longer term.
Provision of teaching for PFMT is patchy.
Many women do not have access to a suitable trainer. Thus, they effectively do their PFMT unsupervised, receiving no feedback as to whether they are contracting their pelvic floor, and thus lacking confidence that they are contracting the correct muscles. Often, they are not informed of the need to adhere to the recommended regime, and are not followed up.
The Pelvic Toner™ device (PTD) introduces resistance against the pelvic floor contraction intra-vaginally, and closure of the limbs of the device demonstrates to the user that they are contracting the appropriate muscles. We set out to determine the feasibility of using the PTD in aiding PFMT by undertaking a pilot randomised controlled trial.
Materials and methods
The pelvic toner device
A single-centre, parallel group, randomised controlled pilot study was carried out. Prior to screening, potential participants were sent a 4-day bladder diary to complete, detailing their voiding frequency, the incidence of SUI and urgency incontinence (UI) episodes and the volumes of urine voided. Women over 18 years of age with symptoms of pure SUI or stress-predominant mixed urinary incontinence (a minimum of three stress urinary leaks per week based on a bladder diary), who had not undergone surgery for incontinence, were recruited over a 1-year period. Study interventions took place within North Bristol NHS Trust secondary care facility.
Exclusion criteria comprised: pregnancy, < 12 weeks post-partum, taking duloxetine hydrochloride, recent or recurrent urinary tract infection, neurological disease, post-void residual ≥ 100 mL and significant pelvic organ prolapse (that is prolapse visible through the introitus on maximum straining in a supine position). The ability to perform a voluntary pelvic floor muscle contraction was confirmed in all women (pre-randomisation) using a perineometer (Peritron 9300 V). Women with a voluntary increment of ≤ 5 cm of water were excluded (n = 2) and offered a referral to a specialist physiotherapist for intensive instruction in PFMT ± biofeedback.
The computer randomisation sequence was generated independently of the investigators; randomisation slips were placed into opaque, sequentially numbered envelopes, which were sealed until interventions were assigned. Participants were enrolled by a urology research nurse who administered the intervention based on the randomisation. Because of the nature of the intervention, blinding of both subject and nurse as to treatment group was unfeasible.
Standard treatment group (ST), i.e. un-resisted PFMT
The pelvic toner group (PTD), i.e. PFMT employing the PTD
Following randomisation, women in both groups underwent a 1-h session with a health care professional, in which they were individually informed of the anatomy and function of the pelvic floor muscles and how to contract them correctly. All subjects were given a PFMT leaflet specifically adapted for the study to refer to at home. Subjects in the PTD group additionally were given a PTD, together with written and verbal instruction on its use.
Women were instructed to carry out a standardised PFMT regime consisting of five “quick” and five “slow” (sustained), high-intensity pelvic floor contractions twice a day over a 16-week period. This regime was chosen as a compromise between the NICE recommendations of a minimum of eight pelvic floor muscles contractions repeated three times daily and the need for subjects to find the time to carry out exercises in the supine position with or without the PTD. The combination of “quick” and “slow” exercises is advocated by continence advisors / physiotherapists within the recruiting site. Participants were advised to hold the sustained contractions for as long as possible, relaxing their pelvic floor muscles for an equivalent time before repeating the process. To ensure the groups were comparable, all subjects were instructed to carry out the PFMT regime in the supine position as this is necessary when using the PTD. Subjects in the PTD group were instructed to use the PTD concurrently whilst executing the PFMT regime. After 2 weeks, all subjects were followed up by telephone in order to answer queries and reinforce technique, with further face-to-face reviews taking place at 8 and 16 weeks following commencement of treatment. During these visits, training diaries were reviewed and a general discussion as to compliance or any issues with PFMT ± PTD technique reinforcement took place.
Women were followed up for 6 months after the completion of their active treatment period (i.e.16 weeks of PFMT ± the pelvic toner) with a view to investigating the longer term acceptance of the pelvic toner, quantifying the number of women who opted to continue using the device and to evaluate perceived efficacy compared with un-resisted PFMT. Participants were sent ICIQ questionnaires identical to those employed within the treatment phase of the study. In addition, a questionnaire specifically designed to evaluate compliance with treatment and perceived efficacy (PFMT 6-month follow-up questionnaire) was also dispatched to research participants; this questionnaire had slightly different versions specific to the two treatment groups, and included space for supplementary free text feedback regarding the pelvic toner, PFMT and the study overall.
In order to ensure consistency between participants in the PTD group, women were given the lower resistance spring only and instructed to use it in the first (i.e. weakest) position of resistance (nearer the hinge) throughout the treatment period. This was necessary in order to have a direct comparison not confounded or otherwise affected by different levels of resistance, but the manufacturer recommends increasing device resistance progressively with ongoing use.
The primary outcome measure was subject-reported improvement, defined as positive change in participant’s response to question 11a of the ICIQ-Female Lower Urinary Tract Symptoms (FLUTS) questionnaire when administered at screening and on completion of the treatment period.1
Secondary outcome measures included subjective reports of “cure”, defined as the response of “never” to question 11a ICIQ-FLUTS following the treatment period. Other measures included: the ICIQ-Urinary Incontinence (UI) Short Form and ICIQ-Lower Urinary Tract Symptoms quality of life (LUTSqol) questionnaires, the Patient Satisfaction Question (PSQ), Global Perception of Improvement (GPI), and Estimated Percent Improved (EPI). Subjective opinions regarding satisfaction and acceptability of treatment were also sought throughout the study period. Women were re-issued these questionnaires at treatment completion (16 weeks).
At 6 months, participants were sent the ICIQ-FLUTS, ICIQ-LUTSqol and the PFMT 6-month follow up questionnaire.
Women’s responses to key items on the questionnaires were cross-tabulated against the randomly allocated treatment groups at baseline and follow-up, and an assessment of group differences was undertaken using Pearson’s Chi-squared test of association. For the primary and secondary outcome measures an assessment of the percentage of patients reporting “an improvement”, “no change”, or “a worsening” over the duration of the study was undertaken within treatment groups and 95 % confidence intervals were reported. Trends over time within each group were investigated using the sign test for repeated measures and a comparative assessment of changes between randomised groups was conducted using the Chi-squared test of association. For ordinal measures, a comparison between groups was undertaken using the Mann–Whitney test. For ordinal changes over time, the Wilcoxon test was applied to carry out the comparison. Analyses were conducted on an intention-to-treat basis.
The study was approved by the Southmead Research Ethics Committee (REC: 07/H0102/41).
Sixty-five subject screenings took place resulting in 52 randomisations. In total 40 subjects completed the treatment period (ST: n = 19, PTD: n = 21); the remaining 12 dropped out, predominantly because of time constraints and/or ill health. The mean (range) age of participants was 49.6 years (36–68), and mean (range) duration of symptoms 5 years (6 months to 30 years). Thirty-six out of 40 subjects had children, with a median parity of 2. There were no significant demographic differences between the two groups.
Based on the 4-day bladder diary completed prior to screening, 10 women reported mixed urinary incontinence (range 1–6 urgency incontinence episodes over 4 days); the remaining 30 women presented with pure SUI, reporting an average of 7 SUI episodes over the diary period (range 3–20).
Analysis of the responses to the ICIQ-FLUTS, ICIQ-LUTSqol and the ICIQ-UI Short Form questionnaires showed no significant differences between the groups in relation to the frequency of urine leakage, pad use and the overall impact of urinary symptoms on everyday life at baseline.
Frequency (percentage) of responses to Q11a of the ICIQ-FLUTS questionnaire: does urine leak when you are physically active, exert yourself, cough or sneeze?
Most of the time
All of the time
At 6 months, 28 participants (70 %) returned the ICIQ questionnaires. There were no statistically significant differences in the responses to Q11 on the ICIQ-FLUTS between the groups at 6 months (χ2 = 7.754, df = 4, p = 0.089).
In analysing the primary outcome measure, 52.4 % (11 out of 21) in the PTD group and 52.6 % (10 out of 19) receiving ST reported symptom improvement following the treatment phase. No women in the PTD group (n = 0) and 10.5 % (n = 2) subjects in the ST group reported “cure”.
Number (percentage) of women doing pelvic floor muscle training (PFMT) at 6 months by group
Following the treatment period, participants were asked to complete an assessment of their Global Perception of Improvement (GPI), i.e. to rate how they felt about their symptoms following treatment. Seventy-five percent of subjects in both the PTG and the ST groups reported feeling “better” or “much better” after the treatment period.
User feedback on the pelvic toner
That the PTD helped to isolate and focus on contracting the correct muscles
That the PTD helped sustain motivation to keep going with PFMT
One woman remarked that the PTD increased her confidence by providing “…something tangible to measure the squeeze”.
This pilot study demonstrates the feasibility of PTD for aiding PFMT. There was no significant difference in the clinical outcome between PTD-aided PFMT and standard PFMT in our sample. The PTD is safe and well tolerated and provides women with choice in managing their condition.
Standard of care advocated by NICE and the ICI is supervised PFMT, but the reality of service provision often falls short of this. In some places, women may not be advised about PFMT at all, or simply be given a leaflet about PFMT, with no assessment of correct muscle contraction. In this setting, the biofeedback given by the PTD may be particularly helpful to demonstrate to the woman that she is contracting her pelvic floor muscles appropriately. This is a pilot study whose aim is to compare the efficacy and acceptability of the PTD against standard of care (PFMT), but also to generate data to inform further research of the PTD.
Ferguson et al.  compared PFMT alone versus PFMT using an intravaginal balloon in 20 women with SUI. They found that the use of the balloon did not improve performance of the pelvic muscles or decrease urinary incontinence compared with PFMT alone. The Cochrane review by Herbison and Dean  looking at vaginal cones for female SUI found 17 studies involving 1,484 women, all of them were small studies, and in many the quality was hard to judge. The authors concluded that vaginal cones were better than no treatment and that they “may be” of similar effectiveness to PFMT and electrostimulation, but the conclusion remained tentative pending larger, high-quality studies.
For skeletal muscle, resistance to contraction represents a loading that requires additional contractile effort, and is an element of strength and endurance training. For pelvic floor function, contractile endurance is important for sustaining continence throughout the day. By introducing intravaginal resistance, the PTD might facilitate development of pelvic floor endurance strength. Speed of response to enable a rapid contraction in anticipation of imminent physical stress is another important facet of PFMT, which is why the PFMT regime incorporated “quick” pelvic floor contractions. PFMT regimes combining speed and endurance training appear to offer the prospect of improving symptom severity in SUI.
Compliance with PFMT regimes in the longer term is essential to achieving benefits, and healthcare professional input at the outset is appropriate for ensuring that contractions are done correctly, and to reinforce the need to sustain compliance over a sufficient duration. Such input is generally given in an initial consultation and follow-up after a few months. In reality, many people may find it difficult to reproduce unaided at home what they may successfully have achieved with the healthcare professional providing positive feedback. Where a woman is not confident that she is correctly contracting her pelvic floor, she is less likely to comply with the PFMT routine. As elicited in user feedback, the PTD helped women gain confidence that they were contracting their pelvic floor correctly, and this may be helpful encouragement when a woman is starting out on a regime of PFMT.
In conclusion, this pilot study demonstrates the feasibility of a novel resistance trainer, the PTD, for aiding PFMT. It is a safe and well-tolerated adjunct in PFMT. However, a quarter of women did not complete the assigned therapy. These preliminary data will be useful to inform further research investigating the full functionality of the pelvic toner at different resistance settings and in different patient populations.
ICIQ-FLUTS 11a) Does urine leak when you are physically active, exert yourself, cough or sneeze? Response: Never, occasionally, sometimes, most of the time, all of the time.
The authors would like to thank all the women who took part in the study.
Conflicts of interest
Funding was via an unrestricted grant from Solution Project Management, UK. The design, data collection, analysis and writing up were independently undertaken by the investigators, with no corporate input.
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