Clinical trial NCT06595732: Contin-RUN Study: Urinary Incontinence in Female Runners
Official title: Contin-RUN Study: Prevalence and Conservative Treatment of Urinary Incontinence in Female Runners
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence
female runner
pelvic floor muscle training
Abdominal Hypopressive Technique
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 174
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Amount of urinary leakage during running
timeFrame: From enrollment to the end of the treatment at 12 weeks
Secondary outcomes:
measure: Frequency of urinary leakage
timeFrame: From enrollment to the end of the treatment at 12 weeks
measure: Other pelvic floor dysfunction symptoms
timeFrame: From enrollment to the end of the treatment at 12 weeks
measure: Pelvic floor muscle strength
timeFrame: From enrollment to the end of the treatment at 12 weeks
measure: Pelvic floor manometry
timeFrame: From enrollment to the end of the treatment at 12 weeks
measure: Impact of urinary incontinence in the quality of life
timeFrame: From enrollment to the end of the treatment at 12 weeks
Other outcomes:
Locations:
city: Uberlândia
country: Brazil
facility: Benjamin Constant St, 1286
state: Minas Gerais
Study officials:
References: