A Study of Incoxil Food Supplement in Female Patients With Stress Dominant Urinary Incontinence.

Fempharma

Status: Completed

Conditions: Urinary Incontinence

Treatments: Dietary Supplement: Incoxil food supplement and pelvic floor muscle exercise; Other: Pelvic floor muscle exercise

Study type: Interventional

Funder types: Industry

Identifiers

NCT05358769

2022INCOXIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stress UI or stress-dominant mixed UI (stress percent score more than urge percent score)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Incoxil supplement group

Experimental group

Description:

Incoxil supplement-group: receive daily oral Incoxil supplementation and perform pelvic floor muscle exercise (PFME) for 6 weeks.

Treatment:

Dietary Supplement: Incoxil food supplement and pelvic floor muscle exercise

Control group

Active Comparator group

Description:

Control group: receive placebo oral daily supplementation and perform pelvic floor muscle exercise (PFME) for 6 weeks.

Treatment:

Other: Pelvic floor muscle exercise