Pelvic Floor Muscle Training vs. Pilates Exercises for Urinary Incontinence

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-70
SponsorUniversidade Estadual do Norte do Parana

About this trial

Urinary incontinence (UI) affects approximately 40% of postmenopausal women and is therefore considered a public health problem. Conservative treatment is recommended, and pelvic floor muscle training (PFMT) is considered the gold standard for this condition.

However, other exercise options have been studied, such as Pilates exercises, which focus on stabilizing muscles and require voluntary contraction of the pelvic floor muscles. The literature remains inconclusive regarding the effects of Pilates exercises on urinary incontinence and pelvic floor muscle function. Objective: To compare the effects of 3 months of muscle training, through PFMT and Pilates exercises, on improving UI in postmenopausal women. Methods: Twenty-four postmenopausal women with urinary incontinence will be randomized into two intervention groups: pelvic floor muscle training and mat Pilates exercises. Assessments will be conducted before and after three months of intervention and will include the following instruments: urinary incontinence and quality of life, assessed using the International Consultation of Urinary Incontinence Short Form (ICIQ-UI-SF) questionnaire; a 7-day voiding diary to identify potential modifiable factors related to urination and its frequency; a Pad test to identify and quantify UI; the Female Sexual Function Index to assess female sexual function; and pelvic floor muscle strength and endurance by bidigital palpation using the PERFECT test. Shapiro-Wilk tests will be used to assess normality, Student's t-test or Mann-Whitney U test according to parametric or nonparametric distribution, and ANCOVA will be used to compare groups post-intervention, considering a 95% confidence interval (p\<0.05). Data will be processed using SPSS 25.0.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being naturally post-menopause (at least one year without menstruating);

Demonstrate independence to carry out activities of daily living;

Have a report of urinary loss when performing physical exertion.

Disqualifiers

Women who have had hysterectomy or oophorectomy surgery;

Women who underwent cancer treatment with hormone therapy;

Present cognitive deficits or neurological diseases;

Practice any type of physical activity regularly in the last six months; Present inability to hire PFM (Oxford Scale < 1);

Trial design

Design model

Parallel

Treatments tested in this trial

  • PFMT

    Other intervention

    O PFMT consistirá em 10 contrações voluntárias máximas que devem ser mantidas por pelo menos 6 segundos. Os participantes serão incentivados a sustentar a contração máxima por um tempo maior a cada semana. O intervalo entre as contrações será de segundos. Os participantes realizarão 4 séries de 10 contrações e, ao final de cada série de 10 contrações, serão realizadas cinco contrações rápidas. Cada série será realizada em uma posição: deitado em decúbito lateral; sentado; de quatro apoios e em pé.

  • Pilates exercises

    Other intervention

    The Pilates group will perform 10 solo exercises, containing stretching and strengthening for the main muscle groups, with a single series of 10 repetitions.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Pelvic Floor Muscle TrainingActive comparator 1 intervention
Group B: Pilates exercises (PE)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Voiding diary

Identifies the frequency of urinary leakage. The participant will record, over the course of 7 days, at home, the number of episodes of urinary leakage during some effort, such as coughing, sneezing or jumping. If there are more than 3 urinary losses within a 7-day interval, the test is positive for UI.

Time frame
12 weeks
2

International Consultation of Urinary questionnaire Incontinence Short Form (ICIQ-UI-SF)

Specific quality of life questionnaire for each aspect related to UI. It consists of four questions; the sum of the first three questions gives the score, and the fourth describes the type of UI. The maximum total score is 21, and the higher the score, the worse the UI severity and disorder.

Time frame
12 weeks
3

PERFECT test

As a complement to the manometric evaluation, bidigital palpation will be performed. The PFM strength and resistance level will be classified using the modified Oxford scale, where 0 is the absence of muscle strength and 5 means a strong contraction with movement correct "squeeze" and "suction". Participants will attempt maximum contractions in terms of strength and endurance three times, with 30-second rest intervals between contractions. The closer to a score of 5, the better the MAP.

Time frame
12 weeks
4

FSFI Questionnaire (Female Sexual Function Index)

To assess women's sexual function, the domains: desire, arousal, lubrication, orgasm, satisfaction and pain are used. It has 19 items. Each question presents a possibility of response with a pattern from 0 to 5, where at the end you can have the result of the scores of each domain and also of the total score, where values below or equal to 26.55 indicate sexual dysfunction.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.