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Contin-RUN Study: Urinary Incontinence in Female Runners

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06595732
Acronym
Contin-RUN
Enrollment
120
Registered
2024-09-19
Start date
2024-09-20
Completion date
2026-03-10
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

urinary incontinence, female runner, pelvic floor muscle training, Abdominal Hypopressive Technique

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

Interventions

BEHAVIORALPelvic 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.

BEHAVIORALAbdominal 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.

OTHERPelvic 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.

Sponsors

Federal University of Uberlandia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Amount of urinary leakage during runningFrom enrollment to the end of the treatment at 12 weeksThe severity of urinary incontinence is the primary outcome of interest. The amount of urinary leakage will be assessed using a modified 1-hour pad test. The pad test will be performed on a treadmill. The participant will drink 500 ml of water in 15 minutes, wait another 15 minutes in rest, place a pre-weighed pad in her underwear, and then run continuously for 40 minutes on the treadmill at a comfortable speed of her choice. After the running period, the pad will be removed and weighed to determine the amount of urinary leakage in grams.

Secondary

MeasureTime frameDescription
Frequency of urinary leakageFrom enrollment to the end of the treatment at 12 weeksThe frequency of urinary leakage will be evaluated through a bladder diary. The bladder diary will be completed over three days, during which the participant will record daytime urinary frequency, nighttime urinary frequency, the number of urinary leakage episodes, and the number of pad changes (if that\'s the case). The information will be logged for three consecutive days, and the participant will be required to run on at least two of those days.
Other pelvic floor dysfunction symptomsFrom enrollment to the end of the treatment at 12 weeksIn order to achieve this outcome, The Pelvic Floor Distress Inventory (PFDI-20) will be used. This is a self-administered quality of life questionnaire containing 20 questions that assess whether the individual has specific symptoms related to the bowel, bladder, or pelvis. If they do, they must rate how bothersome these symptoms are. Scores range from 0 to 100, the higher the score, the greater the discomfort in woman\'s life.
Pelvic floor muscle strengthFrom enrollment to the end of the treatment at 12 weeksPelvic floor muscle strength will be assessed through vaginal palpation. Palpation will be performed to measure the strength of the pelvic floor muscles using the modified 0-5 Oxford scale.
Pelvic floor manometryFrom enrollment to the end of the treatment at 12 weeksThe vaginal squeeze pressure of the pelvic floor muscles will be assessed through manometry. The Peritron manometer will be used to measure peak pressure and the average pressure exerted by the contraction of the pelvic floor muscles.
Impact of urinary incontinence in the quality of lifeFrom enrollment to the end of the treatment at 12 weeksThe impact of urinary incontinence on quality of life will be the secondary outcome of interest. To assess this impact, the authors are going to use the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). It is a self-administered tool consisting of four questions that evaluate the frequency, severity, and impact of urinary incontinence, in addition to a set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by women. The overall score is obtained by summing the scores from questions 3, 4, and 5, and the higher the value, the worse the quality of life and the more the symptom affects the individual\'s life.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026