NCT07212478 Pelvic Floor Muscle Training vs. Pilates Exercises for Urinary Incontinence
| NCT ID | NCT07212478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidade Estadual do Norte do Parana |
| Condition | Urinary Incontinence , Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-09-29 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-09-29 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Urinary incontinence (UI) affects approximately 40% of postmenopausal women and is therefore considered a public health problem. Conservative treatment is recommended, and pelvic floor muscle training (PFMT) is considered the gold standard for this condition. However, other exercise options have been studied, such as Pilates exercises, which focus on stabilizing muscles and require voluntary contraction of the pelvic floor muscles. The literature remains inconclusive regarding the effects of Pilates exercises on urinary incontinence and pelvic floor muscle function. Objective: To compare the effects of 3 months of muscle training, through PFMT and Pilates exercises, on improving UI in postmenopausal women. Methods: Twenty-four postmenopausal women with urinary incontinence will be randomized into two intervention groups: pelvic floor muscle training and mat Pilates exercises. Assessments will be conducted before and after three months of intervention and will include the following instruments: urinary incontinence and quality of life, assessed using the International Consultation of Urinary Incontinence Short Form (ICIQ-UI-SF) questionnaire; a 7-day voiding diary to identify potential modifiable factors related to urination and its frequency; a Pad test to identify and quantify UI; the Female Sexual Function Index to assess female sexual function; and pelvic floor muscle strength and endurance by bidigital palpation using the PERFECT test. Shapiro-Wilk tests will be used to assess normality, Student's t-test or Mann-Whitney U test according to parametric or nonparametric distribution, and ANCOVA will be used to compare groups post-intervention, considering a 95% confidence interval (p\<0.05). Data will be processed using SPSS 25.0.
Eligibility Criteria
Inclusion Criteria: * Being naturally post-menopause (at least one year without menstruating); * Demonstrate independence to carry out activities of daily living; * Have a report of urinary loss when performing physical exertion. Exclusion Criteria: * Women who have had hysterectomy or oophorectomy surgery; * Women who underwent cancer treatment with hormone therapy; * Present cognitive deficits or neurological diseases; * Practice any type of physical activity regularly in the last six months; Present inability to hire PFM (Oxford Scale \< 1); * Report pain or discomfort in the vulva or vagina; * Present dyspareunia, vaginismus or pelvic organ prolapse greater than grade II in the Baden-Walker classification; * Present symptoms of urinary infection at the time of evaluation; * Have participated in previous pelvic floor reeducation programs.
Contact & Investigator
Laís Campos de Oliveira, PhD
PRINCIPAL INVESTIGATOR
Universidade Estadual do Norte do Paraná
Frequently Asked Questions
Who can join the NCT07212478 clinical trial?
This trial is open to female participants only, aged 50 Years or older, up to 70 Years, studying Urinary Incontinence , Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07212478 currently recruiting?
Yes, NCT07212478 is actively recruiting participants. Contact the research team at oliveiralc@uenp.edu.br for enrollment information.
Where is the NCT07212478 trial being conducted?
This trial is being conducted at Jacarezinho, Brazil.
Who is sponsoring the NCT07212478 clinical trial?
NCT07212478 is sponsored by Universidade Estadual do Norte do Parana. The principal investigator is Laís Campos de Oliveira, PhD at Universidade Estadual do Norte do Paraná. The trial plans to enroll 24 participants.