Contin-RUN Study: Urinary Incontinence in Female Runners

NCT ID: NCT06595732

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-03
• Study Completion Date: 2025-07-20

Brief Summary

This study comprises two phases, each with distinct objectives. The first phase aims to investigate the prevalence of urinary incontinence and other pelvic floor dysfunctions in Brazilian female runners through structured questionnaires. The second phase aims to evaluate and compare the effectiveness of three different exercise regimens for the treatment of urinary incontinence in female runners. The intervention groups include: a) pelvic floor muscle training combined with abdominal training, b) hypopressive abdominal exercises, and c) pelvic floor muscle training alone. The primary outcome measure is the severity of urinary incontinence, which will be assessed using the adapted 1-hour pad test and a 3-day bladder diary. Secondary outcomes include symptoms of pelvic floor dysfunction and pelvic floor muscle function. The intervention will last for 12 weeks, after which participants will be reassessed to determine which training regimen is most effective in treating urinary incontinence in female runners.

Detailed Description

This study has two stages with distinct objectives. The first stage aims to investigate the prevalence of urinary incontinence and other pelvic floor dysfunctions in Brazilian female runners. To achieve this goal, a survey will be conducted using a questionnaire, which will include questions about demographic data, general gynecological and obstetric health (menopause, pregnancies, deliveries), training specifics (weekly volume, time spent running, practice of other exercises, how the training is conducted), and questions related to pelvic floor dysfunctions (urinary incontinence, fecal incontinence, sexual dysfunctions, and symptoms of genital prolapse). For this study, it is estimated that at least 400 female runners will respond to the questionnaire.

The second stage aims to compare three types of exercise programs for the treatment of urinary incontinence in runners: (1) pelvic floor muscle training combined with abdominal training; (2) hypopressive abdominal gymnastics; or (3) pelvic floor muscle training. The primary outcome of interest is the severity of urinary loss, assessed by a 1-hour adapted pad test and a 3-day voiding diary. Secondary outcomes will include symptoms related to urinary incontinence and other dysfunctions. For this purpose, the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and Pelvic Floor Distress Inventory (PFDI-20) will be used. Lastly, pelvic floor muscle function will be assessed through vaginal palpation, quantified using the Oxford scale, and through vaginal manometry. After agreeing to participate and signing the informed consent form, the women will be evaluated and then randomized into one of the three previously described groups. The exercises will be performed over a 12-week period. The women will then be re-evaluated. A sample size calculation was performed, and 58 participants will be required in each group to verify the superiority of one type of exercise over the others.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1PFMT + Abd Group

Participants in this group will perform pelvic floor muscle training in conjunction with abdominal muscle training. It is believed that abdominal contraction will lead to an increase in abdominal pressure, which will serve as additional load for pelvic floor muscle training.

Group Type: EXPERIMENTAL

Pelvic floor and abdominal training

Intervention Type: BEHAVIORAL

Participants in this group will undergo 12 weeks of in-person training, with supervision by a specialist physical therapist, in groups of up to four women. The training will take place after an initial evaluation and will consist of 24 sessions, held twice a week. Exercises will target both the pelvic floor muscles and the abdominal muscles. The exercises will be divided into three phases, with progressively increasing difficulty each month. The progression will be achieved by increasing the load, the number of repetitions, and the complexity of the exercises.

AHG Group

Participants in this group will perform Hypopressive Abdominal Gymnastics exercises (Caufriez, 1997). It is believed that these exercises reduce the pressure on the pelvic floor muscles and help tone this musculature without causing harm.

Group Type: EXPERIMENTAL

Abdominal Hypopressive Technique Exercises

Intervention Type: BEHAVIORAL

Participants in this group will perform Hypopressive Abdominal Gymnastics exercises as proposed by Marcel Caufriez (1997). The training will last 12 weeks and be conducted in person, with supervision by a specialist physical therapist, in groups of up to four women. The training will take place after an initial evaluation and will consist of 24 sessions, held twice a week. The exercises will be divided into three phases, with progressively increasing difficulty each month. Progression will be achieved by changing body positions, increasing the number of repetitions, and extending the duration of inspiratory apnea.

PFMT Group

Participants of PFMT group will perform specific exercises for the pelvic floor muscles, with maximum contraction and without involvement of other muscle groups. This arm is considered the control group because it is the treatment that has been proven to effectively treat urinary incontinence, as demonstrated in over 50 clinical trials.

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle training

Intervention Type: OTHER

Participants in this group will undergo 12 weeks of in-person training, supervised by a specialist physical therapist, in groups of up to four women. Specific exercises targeting the pelvic floor muscles will be performed, with voluntary and maximal contractions, without involving other muscle groups. The exercises will be divided into three phases, with progressively increasing difficulty each month. Progression will be achieved by increasing the load (transitioning from gravitational to antigravitational positions), increasing the number of repetitions, and combining sustained and rapid contractions to enhance the difficulty of execution.

Interventions

Pelvic floor and abdominal training

Participants in this group will undergo 12 weeks of in-person training, with supervision by a specialist physical therapist, in groups of up to four women. The training will take place after an initial evaluation and will consist of 24 sessions, held twice a week. Exercises will target both the pelvic floor muscles and the abdominal muscles. The exercises will be divided into three phases, with progressively increasing difficulty each month. The progression will be achieved by increasing the load, the number of repetitions, and the complexity of the exercises.

Intervention Type: BEHAVIORAL

Abdominal Hypopressive Technique Exercises

Participants in this group will perform Hypopressive Abdominal Gymnastics exercises as proposed by Marcel Caufriez (1997). The training will last 12 weeks and be conducted in person, with supervision by a specialist physical therapist, in groups of up to four women. The training will take place after an initial evaluation and will consist of 24 sessions, held twice a week. The exercises will be divided into three phases, with progressively increasing difficulty each month. Progression will be achieved by changing body positions, increasing the number of repetitions, and extending the duration of inspiratory apnea.

Intervention Type: BEHAVIORAL

Pelvic floor muscle training

Participants in this group will undergo 12 weeks of in-person training, supervised by a specialist physical therapist, in groups of up to four women. Specific exercises targeting the pelvic floor muscles will be performed, with voluntary and maximal contractions, without involving other muscle groups. The exercises will be divided into three phases, with progressively increasing difficulty each month. Progression will be achieved by increasing the load (transitioning from gravitational to antigravitational positions), increasing the number of repetitions, and combining sustained and rapid contractions to enhance the difficulty of execution.

Intervention Type: OTHER

Other Intervention Names

Hypopressive Exercises

Eligibility Criteria

Inclusion Criteria

• Participants must have been running for at least six months
• Run at least 15 kilometers per week,
• Have no injuries that have prevented them from running for more than three weeks in the past six months
• Experience involuntary urinary leakage during running
• The women must have a pelvic floor muscle strength of ≥ 2 on the modified Oxford scale

Exclusion Criteria

• Having a diagnosed neuromuscular disease that affects bladder function
• Having undergone previous pelvic or perineal surgeries for the correction of pelvic floor dysfunctions
• Having previously received physical therapy for the treatment of pelvic floor dysfunctions

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Uberlandia

OTHER

Sponsor Role: lead

Responsible Party

Ana Paula Magalhães Resende

Clinical Professor Ana Paula M. Resende, PT, PhD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benjamin Constant St, 1286

Uberlândia, Minas Gerais, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Ana Paula M Resende, PhD

Role: CONTACT

anapaulamrb@ufu.br

55+34998197161

Facility Contacts

Ana Paula M Resende, PT, PhD

Role: primary

anapaulamrb@ufu.br

55+34998197161

Wanessa S Oliveira, Masters Degree Student

Role: backup

55+34997340282

Other Identifiers

75069623.3.0000.5152

Identifier Type: -

Identifier Source: org_study_id