Clinical Trials Directory

Trials / Completed

CompletedNCT06595732

Contin-RUN Study: Urinary Incontinence in Female Runners

Contin-RUN Study: Prevalence and Conservative Treatment of Urinary Incontinence in Female Runners

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Federal University of Uberlandia · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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 40 participants will be required in each group to verify the superiority of one type of exercise over the others.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPelvic floor and abdominal trainingParticipants 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.
BEHAVIORALAbdominal Hypopressive Technique ExercisesParticipants 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.
OTHERPelvic floor muscle trainingParticipants 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.

Timeline

Start date
2024-09-20
Primary completion
2026-01-10
Completion
2026-03-10
First posted
2024-09-19
Last updated
2026-03-16

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT06595732. Inclusion in this directory is not an endorsement.