Urinary IncontinenceContin-RUNNCT06595732
Contin-RUN Study: Urinary Incontinence in Female Runners
A study testing Pelvic floor and abdominal training, Abdominal Hypopressive Technique Exercises and Pelvic floor muscle training in people with Urinary Incontinence, run by Federal University of Uberlandia at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Pelvic floor and abdominal training, Abdominal Hypopressive Technique Exercises and Pelvic floor muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Sep 2024to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contin-RUN Study: Prevalence and Conservative Treatment of Urinary Incontinence in Female Runners
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.
Read the 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
- Urinary Incontinence
- Being tested
- Pelvic floor and abdominal training, Abdominal Hypopressive Technique Exercises, Pelvic floor muscle training
- Keywords
- urinary incontinence, female runner, pelvic floor muscle training, Abdominal Hypopressive Technique
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor and abdominal trainingBehavioural
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.
Abdominal Hypopressive Technique ExercisesBehavioural
Also called Hypopressive 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.
Pelvic floor muscle trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1PFMT + Abd Group | Experimental | 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. Receives: Behavioral: Pelvic floor and abdominal training |
| AHG Group | Experimental | 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. Receives: Behavioral: Abdominal Hypopressive Technique Exercises |
| PFMT Group | Active comparator | 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. Receives: Other: Pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of urinary leakage during running
The 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.
Measured: From enrollment to the end of the treatment at 12 weeks
Secondary outcomes (5)
Frequency of urinary leakage
The 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.
Measured: From enrollment to the end of the treatment at 12 weeks
Other pelvic floor dysfunction symptoms
In 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.
Measured: From enrollment to the end of the treatment at 12 weeks
Pelvic floor muscle strength
Pelvic 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.
Measured: From enrollment to the end of the treatment at 12 weeks
Pelvic floor manometry
The 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.
Measured: From enrollment to the end of the treatment at 12 weeks
Impact of urinary incontinence in the quality of life
The 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.
Measured: From enrollment to the end of the treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2024
- Primary completion10 Jan 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Paula Magalhães Resende, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595732
- Sponsor's protocol ID
- 75069623.3.0000.5152
- Acronym
- Contin-RUN
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After data collection, the research team will meet to decide whether to share individual evaluation data, while ensuring that participants are not identified for ethical reasons. Spreadsheets containing data on outcomes for each individual, as well as other information such as age, body mass index, menopause status, etc., may be shared to facilitate the development of systematic reviews and meta-analyses on the topic. This would benefit the entire scientific and academic community, and ultimately the general population, as understanding the best treatment evidence helps individuals receive more targeted and effective treatment.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contin-RUN Study: Prevalence and Conservative Treatment of Urinary Incontinence in Female Runners
- ClinicalTrials.gov ID
- NCT06595732
- Acronym / sponsor ID
- Contin-RUN / 75069623.3.0000.5152
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, female runner, pelvic floor muscle training, Abdominal Hypopressive Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1PFMT + Abd Group | Experimental | Behavioral: Pelvic floor and abdominal trainingParticipants 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. |
| AHG Group | Experimental | Behavioral: Abdominal Hypopressive Technique ExercisesParticipants 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. |
| PFMT Group | Active comparator | Other: Pelvic floor muscle trainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic 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. | Behavioural | 1PFMT + Abd Group |
| Abdominal Hypopressive Technique ExercisesAlso: Hypopressive 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. | Behavioural | AHG Group |
| Pelvic 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. | Other | PFMT Group |
Primary outcome
Amount of urinary leakage during running
Time frame: From enrollment to the end of the treatment at 12 weeks
The 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.
5 secondary outcomes
Frequency of urinary leakage
Time frame: From enrollment to the end of the treatment at 12 weeks
Other pelvic floor dysfunction symptoms
Time frame: From enrollment to the end of the treatment at 12 weeks
Pelvic floor muscle strength
Time frame: From enrollment to the end of the treatment at 12 weeks
Pelvic floor manometry
Time frame: From enrollment to the end of the treatment at 12 weeks
Impact of urinary incontinence in the quality of life
Time frame: From enrollment to the end of the treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Undecided. After data collection, the research team will meet to decide whether to share individual evaluation data, while ensuring that participants are not identified for ethical reasons. Spreadsheets containing data on outcomes for each individual, as well as other information such as age, body mass index, menopause status, etc., may be shared to facilitate the development of systematic reviews and meta-analyses on the topic. This would benefit the entire scientific and academic community, and ultimately the general population, as understanding the best treatment evidence helps individuals receive more targeted and effective treatment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor and abdominal training, Abdominal Hypopressive Technique Exercises and Pelvic floor muscle training in people with Urinary Incontinence, run by Federal University of Uberlandia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of urinary leakage during running (time frame: From enrollment to the end of the treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.