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Effect of Pelvic Floor Muscle Training Combined With Dietary Supplementation on Urinary Incontinence and Pelvic Floor Muscle Function in Women
Sponsor: FEMPHARMA Kft.
Summary
Pelvic floor muscle training (PFMT) is commonly used in the conservative management of urinary incontinence. The aim of the study is to investigate changes in urinary incontinence symptoms and pelvic floor muscle function during a treatment program involving pelvic floor muscle exercises and the use of a dietary supplement. The study includes women suffering from stress, urge, or mixed urinary incontinence. Participants undergo a baseline assessment followed by follow-up visits after 4 weeks and 12 weeks. At the baseline visit, demographic and medical information is collected, including age, chronic diseases, regularly used medications, height, weight, pregnancy and delivery history, menopausal status, and previous surgical procedures. Urinary incontinence symptoms are assessed using the Medical, Epidemiologic and Social Aspects of Aging (MESA) questionnaire. Participants also complete the Patient Global Impression of Severity (PGI-S), the Incontinence Impact Questionnaire short form (IIQ-7), the Urinary Distress Inventory short form (UDI-6), and the SF-12 Health Survey. Pelvic floor and pelvic organ status are evaluated using Vaginal Tactile Imaging (VTI), the Pelvic Organ Prolapse Quantification (POP-Q) system, perineometer measurements, and manual assessment of pelvic floor muscle strength using the Oxford scale. Three perineometer measurements are recorded. Participants receive the dietary supplement as well as a urinary diary and instructions and a diary for pelvic floor muscle exercises. At the second visit, performed after 4 weeks, participants complete the Patient Global Impression of Improvement (PGI-I), IIQ-7, and UDI-6 questionnaires to assess changes in symptoms and their impact on daily activities and quality of life. The third visit is performed after 12 weeks. Participants again complete the PGI-I, IIQ-7, and UDI-6 questionnaires. Pelvic floor and pelvic organ assessments are repeated, including Vaginal Tactile Imaging, POP-Q assessment, three perineometer measurements, and manual evaluation of pelvic floor muscle strength using the Oxford scale. Changes in urinary incontinence symptoms, quality of life, patient-reported improvement, and objective pelvic floor muscle parameters are evaluated over the 12-week study period.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-10-01
Completion Date
2027-12-31
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
Incoxil
Participants will receive a dietary supplement in combination with a structured pelvic floor muscle training (PFMT) program. The intervention is intended to support pelvic floor muscle function and improve symptoms of urinary incontinence. Participants will perform PFMT regularly throughout the 12-week study period and will use the dietary supplement according to the study protocol. Clinical symptoms, quality of life, and pelvic floor muscle function will be assessed at baseline and at follow-up visits.
Placebo Control
Participants in the placebo group will receive a placebo dietary supplement designed to match the active dietary supplement in appearance and administration schedule but without the active ingredients. Participants will also follow the same pelvic floor muscle training (PFMT) program as the intervention group throughout the 12-week study period. Clinical symptoms, quality of life, and pelvic floor muscle function will be assessed at baseline and during follow-up visits.