A Study of Incoxil Food Supplement in Female Patients With Stress Dominant Urinary Incontinence.
- Conditions
- Urinary Incontinence
- Interventions
- Other: Pelvic floor muscle exerciseDietary Supplement: Incoxil food supplement and pelvic floor muscle exercise
- Registration Number
- NCT05358769
- Lead Sponsor
- FEMPHARMA Kft.
- Brief Summary
The purpose of this study is compare the effectiveness of Incoxil food supplement and pelvic floor muscle training with pelvic floor muscle training alone in the treatment of women with stress dominant urinary incontinence.
- Detailed Description
Pelvic floor muscle training (PFMT) is the first line therapy recommended for the treatment of stress urinary incontinence. The study aims to investigate how poor pelvic floor muscle function can be strengthened by performing pelvic floor exercise and using a special dietary supplement at the same time, and if stress urinary incontinence can be improved more effectively than by performing pelvic floor exercise alone.
The study aims to compare the clinical improvement in the symptoms of stress urinary incontinence in women who do pelvic floor muscle training exercise (PFMT) or who do PFMT exercise and use a dietary supplement. Incoxil dietary supplement contains ingredients that are specifically designed to help strengthen muscles (creatine, l-leucine, zinc, calcium and magnesium).
The randomized controlled clinical trial is proposed involving 34 women diagnosed with stress dominant urinary incontinence and randomized into two groups: 1) treatment with Incoxil dietary supplement and PFMT; 2) treatment with placebo dietary supplement and PFMT. All women will perform PFMT daily and women in group 1 take Incoxil every day, while women in the control group will take daily placebo dietary supplement for 6 weeks.
At baseline assessment, patients shall undergo anamnesis, general gynecological exam, assessments of the pelvic floor based on the modified Oxford scale, the presence of prolapse using the Pelvic Organ Prolapse Quantification (POP-Q) system, pelvic muscle contraction will be measured using a pelvic Perineometer and Vaginal Tactile Imaging will be used for evaluation of vaginal and pelvic floor conditions. We also assess the general health of the vagina with Vaginal Health Index scores. Participants shall complete UDI-6, PGI-S/I and IIQ-7 questionnaires.
After 6 weeks treatment the same assessments will be done to compare treatment and control group results.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 36
- stress UI or stress-dominant mixed UI (stress percent score more than urge percent score)
- pregnancy or less than 12-month postpartum
- more than three vaginal deliveries or any prior operative delivery
- self-reported symptoms of pelvic organ prolapse or POP-Q stage >2
- history of supervised PFMT within 12 months
- current medications for UI
- known zinc or copper deficiency or sensitivity
- connective tissue disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Pelvic floor muscle exercise Control group: receive placebo oral daily supplementation and perform pelvic floor muscle exercise (PFME) for 6 weeks. Incoxil supplement group Incoxil food supplement and pelvic floor muscle exercise Incoxil supplement-group: receive daily oral Incoxil supplementation and perform pelvic floor muscle exercise (PFME) for 6 weeks.
- Primary Outcome Measures
Name Time Method UDI-6 score 6 weeks Comparison of Urogenital Distress Inventory-6 (UDI-6) questionnaire final scores before and after treatment in the two arms.
- Secondary Outcome Measures
Name Time Method Incontinence Impact Questionnaire (IIQ-7) score 6 weeks Comparison of Incontinence Impact Questionnaire (IIQ-7) questionnaire final scores before and after treatment in the two arms.
Patient's Global Impression of Improvement (PGI-I) 6 weeks Patients will be asked answer the PGI-I questionnaire after the 6 week course of therapy.
Vaginal squeeze pressure 6 weeks Pelvic muscle contraction will be measured at week 0 and week 6 using a pelvic perineometer to assess any improvement in pelvic muscle strength.
Vaginal Tactile Imager (VTI) score 6 weeks VTI is used for evaluation of vaginal and pelvic floor conditions at week 0 and week 6, before and after treatment. VTI allows assessment of tissue elasticity, pelvic floor support and function.
Patient's Global Impression of Severity (PGI-S) 6 weeks Comparison of Patient's Global Impression of Severity (PGI-S) questionnaire final scores before and after treatment in the two arms.
Trial Locations
- Locations (1)
Dr. Secret Private Clinic
🇭🇺Debrecen, HB, Hungary