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Completed

NCT Number: NCT05446792

Comparison Between Pelvic Muscle Training and Pilates Exercises for UI in Postmenopausal Women

Introduction: Urinary incontinence (UI) is a condition that affects around 40% of postmenopausal women and is therefore considered a public health problem. Conservative treatment is recommended, and pelvic floor muscle training (PMT) is considered the gold standard for this type of condition. However, other possibilities of exercises have been studied to achieve continence, such as Pilates exercises, which focus on the stabilizing muscles and request a voluntary contraction of the muscles of the pelvic floor (PFM), it is believed that it can recruit fibers from these muscles, improving muscle function and episodes of urinary incontinence. However, the literature is still inconclusive regarding the effects of Pilates exercises on urinary incontinence and PFM function. Objective: To compare the effects of 3 months of muscle training, through TMAP and Pilates exercises on the improvement of UI in postmenopausal women. Methods: 40 postmenopausal women with urinary incontinence will be randomly assigned to two intervention groups: pelvic floor muscle training and Pilates exercises. The evaluations will be carried out before the interventions and after three months of them, and will involve the following instruments: urinary incontinence and aspects related to quality of life, assessed using the International Consultation of Urinary Incontinence questionnaire Short Form (ICIQ-UI-SF); 7-day voiding diary, used to identify possible modifiable factors related to urination and its frequency; Pad-test used to identify and quantify UI; Feeling Scale, to portray the affective valence of the exercises; Female Sexual Function Index, which will assess female sexual function; Manometric assessment of muscle strength and PFM endurance with Epi-no; and Manometric evaluation by bidigital palpation using the PERFECT test. Shapiro Wilk tests will be performed to verify normality, Student's t or Mann Whitney U test according to parametric or non-parametric distribution, ANCOVA for comparison between groups in the post-intervention, considering the 95% confidence interval (p<0.05) . The data will be processed in the SPSS 25.0 program.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Estadual do Norte do Paraná

Jacarezinho, Paraná, 86400000, Brazil

About this study

The sample will be composed of 40 women in the post-menopausal period, that is, who are at least one year without menstruating, and who are aged between 50 and 70 years. The sample size calculation for this study was performed using the Bioestat 5.3 program (Mamirauá Institute, Amazonas, Brazil), taking into account the values of the ICIQ_SF instrument (name in English), made available in a previous study (SCHRADER et al., 2017). In this case, the post-intervention mean and standard deviation between the Pilates group (1.0 ± 1.15) and TMAP (3.42 ± 3.4) were used, with test power at 80% and alpha value at 0.05, which generated the need for 17 participants in each group. In order to meet eventual sample losses, 15% of participants will be added in each group, thus totaling 20 women in the Pilates group and 20 in the TMAP group.

The descriptive analysis of the data will be expressed in the form of mean, standard deviation and percentage delta of the difference. The verification of normality will occur by the Shapiro Wilk test. To verify if there are differences between the groups regarding the initial characteristics (age, weight, height and BMI), at the pre-intervention moment, the Student's t test will be used for independent samples or the Mann Whitney U test, in case the data show parametric or nonparametric distribution, respectively. For comparison between groups in the post-intervention ANCOVA will be used, with baseline data being used as covariates. If the data present a non-parametric characteristic, the comparison between the groups will be made using the Mann-Whitney U test, considering the difference between pre and post-intervention. The admitted confidence interval will be 95% (p<0.05). The data will be processed in the SPSS 25.0 program. Effect sizes (Cohen's d) will be calculated and considered small (0.20), medium (0.50) or large (0.80). For effect size calculations, the program GPower 3.1 (Franz Faul, Universitat Kiel, Germany) will be used.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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);
  • Report pain or discomfort in the vulva or vagina;
  • Present dyspareunia, vaginismus or pelvic organ prolapse greater than grade II in the Baden-Walker classification;
  • Present symptoms of urinary infection at the time of evaluation;
  • Have participated in previous pelvic floor reeducation programs.

Treatment and study plan

PFMT

Other

The PFMT will consist of 10 maximum voluntary contractions that must be maintained for at least 6 seconds. Participants will be encouraged to sustain the maximum contraction for a longer time each week. The interval time between contractions will be the same seconds as the contraction. Participants will perform 4 sets of 10 contractions, and at the end of each set of 10 contractions, five fast contractions will be performed. Each series will be performed in one position: lying in lateral decubitus; seated; on all fours and standing.

PE

Other

The PE group will be instructed and reminded to voluntarily contract the PFMs during each repetition of the Pilates strengthening exercises. During the stretching exercises, the participant will be instructed not to perform the contraction.

The stretching and strengthening exercises will be performed in a single series of 10 repetitions, totaling 10 exercises aimed at the main muscle groups.

Primary outcomes

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

    Time frame: 3 months

    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.

  2. Pad-test

    Time frame: 3 months

    Identifies and quantifies UI. The participant will be instructed to empty the bladder and ingest 500 ml of water, then place a previously weighed absorbent. The participant performs provocative maneuvers that will increase intra-abdominal pressure such as coughing, jumping and crouching, lasting approximately one hour. Soon after, the absorbent will be weighed again. If the absorbent weight is greater than 2 grams, the result was positive, identifying the UI. The greater the final weight of the pad, the greater the amount of urinary loss.

  3. Voiding diary

    Time frame: 3 months

    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.

  4. Manometric assessment of muscle strength and PFM endurance

    Time frame: 3 months

    The manometer probe will be inserted and inflated in the participant's vaginal canal, until the participant feels the probe contacting the vaginal wall. The participant will be guided to contract the MAP. When the musculature contracts, an increase in pressure is observed on the device's display. You will be asked for three maximum contractions with 30 second rest intervals between contractions. The values will be recorded in mmHg and the duration of the contraction will be recorded in seconds. The higher the score, the stronger the MAPs are.

  5. PERFECT test

    Time frame: 3 months

    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.

Secondary outcomes

  1. FSFI Questionnaire (Female Sexual Function Index)

    Time frame: 3 months

    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.

  2. Feeling Scale - Pleasure and displeasure during exercise

    Time frame: 3 months

    The affective valence scale will be used to measure the participants' feelings of pleasure/affection in relation to the exercises. The score goes from +5 meaning pleasure during the exercise with a feeling of "very good"; down to -5, meaning displeasure, presenting the feeling of "very bad" during the execution of the exercise. The closer to +5, the more pleasure in performing the exercise.

Sponsors and collaborators

Lead sponsor

Universidade Estadual do Norte do Parana

Other

Registry information

Official study title

Comparison Between Pelvic Floor Muscle Training and Pilates Exercises on Urinary Incontinence in Postmenopausal Women: Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 7, 2022
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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