Hypothesis / aims of study
Approximately 30 to 50% of women are unable to correctly perform pelvic floor muscle (PFM) contractions. For women to benefit from a pelvic floor muscle training (PFMT) programme for stress urinary incontinence (SUI), the awareness phase of PFMT cannot be omitted (1, 2). This study aimed to evaluate the effects of a program with verbal instructions, body awareness techniques and vaginal palpation of pelvic floor muscle (PFM) on motor control of women with SUI. The hypothesis that vaginal palpation helps in learning the correct contraction and improves PFM coordination by increasing the number of rapid contractions (Fast) after one month of intervention was tested.
Study design, materials and methods
This single-centre, double-blind randomized controlled trial with two intervention groups. A sample size calculation was performed to estimate the number of participants needed to obtain a statistical power of 0.80 at an alpha level of 0.05, patients with SUI (n=172) will be recruited. This trial is actively recruiting participants and ongoing with recruitment continuing to August 2023. Women aged between 18 and 75 with predominant SUI symptoms and ≥ 2 g of leakage as measured by the pad test (n=73), as measured by a 1-h pad test; have not previously undergone physiotherapy for pelvic floor dysfunction; and have at least grade 1 muscle strength (flicker), as assessed by the two-finger assessment and rated according to the Oxford scale (3). Patients will not include if they are younger than 18 years old; have chronic degenerative diseases; have pelvic organ prolapse more severe than stage I, as determined by the POP-Q; have neurologic or psychiatric diseases; have a history of pelvic floor surgeries; or have any intolerance or discomfort in response to the PFM examination. Were recruited from 2017 through August 2020. The Experimental group (n=35) receive verbal instructions on the anatomy and function of the PFM using the principles of body awareness techniques along with vaginal palpation to learn to correctly perform PFM contractions; the Control group (n=38) received verbal instructions of PFM anatomy and function, after the end of the 4-week period, patients received the same protocol as the experimental group. The primary outcome includes the number of fast-twitch muscle fibres assessed by vaginal palpation and visual observation. Secondary outcomes include power and muscular endurance that was assessed by visual observation and vaginal palpation (Oxford scale), the use of accessory muscles during the voluntary contraction of PFM, and the self-efficacy and the expectations for the results using the self-efficacy scale of pelvic floor exercises. To analyze the differences between groups, the likelihood ratio test, Mann-Whitney test, and Fisher's Exact test were used. And to analyze the primary and secondary outcomes and their differences between the moments before and after the intervention the ANOVA with 5% cut for significance was used.
Results
No significant differences were identified between the groups in relation to the primary outcome: 7.4 (±2.3) in the Experimental group, and 7.0 (±2.2) in the Control group (p=0.556). There was a significant increase in the number of fast contractions in both groups after 1 month of intervention (p<0.000), shown in table 1. No statistical difference was detected in muscle performance (Oxford scale) and PFM endurance (Experimental group 3.5 (±0.8) and 3.4 (±1.1) Control group, (p=0.748). Regarding the use of gluteal, abdominal and adductor muscles associated to PFM contraction, it was observed a decrease in the use in both groups, with significant results for the adductor muscle in the Experimental group, from 37% initial to 16% after 1-month and in the Control group, from 81% initial to 44% after 1 month, (p=0.010). Both groups demonstrated self-perception of results, motivation and confidence regarding the benefits of PFM exercises (p=0,283); and in relation to performance expectations that were evaluated only after 1 month of intervention, both groups demonstrated felt able to perform PFM contraction, 71.2 (±18.2) in the Experimental group versus 78.5 (±10.7) in the Control group, (p=0.196).
Interpretation of results
The vaginal palpation technique does not promote a significant increase in the number of fast PFM contractions when compared to verbal instructions; both groups, Experimental and Control, showed improvement in PFM motor control. There was no difference in PFM function (Oxford) and Endurance in both groups after one month of intervention. The performance expectation of the PFM exercises evaluated after one month of intervention was similar in both groups, showed an increase in the score and demonstrated that the women felt able to perform the PFM contraction.