Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595732
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-07
Brief Title:
Contin-RUN Study Urinary Incontinence in Female Runners
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Contin-RUN Study Prevalence and Conservative Treatment of Urinary Incontinence in Female Runners
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Contin-RUN
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None