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

NCT05446792 | Completed DMC

• 1 other identifier: TMAP X Pilates in the UI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence

Keywords

Post-menopause; Pilates; Muscle training of pelvic floor

Outcome Measures

Primary Outcomes (5)

• 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.

  3 months

• Pad-test

  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 months

• 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.

  3 months

• Manometric assessment of muscle strength and PFM endurance

  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.

  3 months

• 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.

  3 months

Secondary Outcomes (2)

• FSFI Questionnaire (Female Sexual Function Index)

  3 months

• Feeling Scale - Pleasure and displeasure during exercise

  3 months

Study Arms (2)

Pelvic floor muscle training (PFMT)

ACTIVE COMPARATOR

For the intervention of the PFMT group, which is non-invasive, a physical therapist experienced in this type of training will carry out the sessions, which will be individualized, in a specific room for care ocused on pelvic physiotherapy, with a stretcher, air conditioning and a lock on the door, for the patient to feel safe.

Other: PFMT

Pilates exercises (PE)

EXPERIMENTAL

For the intervention of the PE group, in the first week the protocol will be used to familiarize the participants with the exercises, where the correct execution of the movements will be demonstrated and each principle of the method will be explained: concentration, centralization, precision, breathing, control and fluidity; and for familiarization with the correct voluntary contraction of the PFM. Participants in the PE group will be instructed and reminded to voluntarily contract the PFM during each repetition of the Pilates strengthening exercises. During the stretching exercises, the participant will be instructed not to perform the contraction. The springs will be changed according to the evolution of the participants, by replacing them with a spring of greater resistance. Basic equipment such as: Cadillac Trapezio, Combo Chair, Universal Reformer, Ladder Barrel and Wall Unit will be used.

Other: PE

Interventions

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.

Pelvic floor muscle training (PFMT)

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.

Pilates exercises (PE)

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Estadual do Norte do Parana: lead

Study Sites (1)

Universidade Estadual do Norte do Paraná

Jacarezinho, Paraná, 86400000, Brazil

Location

Related Publications (2)

• de Andrade RL, Bo K, Antonio FI, Driusso P, Mateus-Vasconcelos ECL, Ramos S, Julio MP, Ferreira CHJ. An education program about pelvic floor muscles improved women's knowledge but not pelvic floor muscle function, urinary incontinence or sexual function: a randomised trial. J Physiother. 2018 Apr;64(2):91-96. doi: 10.1016/j.jphys.2018.02.010. Epub 2018 Mar 21.

  PMID: 29574170 BACKGROUND

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

• Laís C Oliveira, PhD

  Universidade Estadual do Norte do Paraná

  PRINCIPAL INVESTIGATOR

• Raphael G Oliveira, PhD

  Universidade Estadual do Norte do Paraná

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization of the sample will be confidential. A professional in the field who is unaware of the study and the participants will perform the draw through random numbers that will distribute the participants into two groups: Pelvic Floor Muscle Training Group (TMAP) (n= 20) and Pilates Exercise Group (PE) (n= 20). This same professional will deliver the answers in opaque envelopes, which will be sealed and contain the answer. Participants will be duly informed that they can be allocated to either of the two groups at the time of recruitment and selection and, in addition, the participants and the responsible researchers will know in which group each woman will participate at the time of delivery of the envelopes. The evaluations will be carried out before and after three months of interventions, by the same professionals, experienced in these evaluations, who will be blind to the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Teacher Laís Campos de Oliveira

Model Details: The interventions will last for twelve weeks, three times a week, for one hour, on non days consecutive. The Pilates exercises group will perform stretching and strengthening exercises in a single series of 10 repetitions, totaling 10 exercises aimed at the main muscle groups. The Pelvic floor muscle training group will consist of 10 maximal voluntary contractions that must be maintained for at least 6 seconds (participants will be encouraged to sustain the maximal 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: 1st lying in lateral decubitus, 2nd sitting, 3rd on all fours and 4th standing.

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 7, 2022
• Study Start: June 1, 2022
• Primary Completion: December 7, 2022
• Study Completion: February 14, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)