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

Urinary Incontinence Clinical Trial

Official title:

Randomized Clinical Trial to Assess the Effectiveness of Incoxil Food Supplement and Pelvic Floor Muscle Training in Women With Stress Dominant Urinary Incontinence.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05358769
• Other study ID #: 2022INCOXIL
• Status: Completed
• Phase: N/A
• Start date: April 27, 2022
• Est. completion date: September 9, 2022

Study information

• Verified date: February 2023
• Source: FEMPHARMA Kft.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 9, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Dietary Supplement:
• Incoxil food supplement and pelvic floor muscle exercise
Incoxil supplement group receives standardized written and verbal instructions on how to perform PFME and are asked to perform the pelvic floor muscle exercises 3 times per day, with 15 repetitions per set, daily for 6 weeks. Women perform PFME at an intensity of at least 65-75% of one repetition maximum. (Repetition maximum load is the maximum weight or force an individual can exert in a single lift.) In addition participants receive Incoxil food supplement and take the supplement once a day. Incoxil composition: creatine, l-leucine, zinc, calcium and magnesium. Incoxil is specifically designed to contain ingredients that help strengthen muscles during regular resistance training of moderate intensity.

Other:
• Pelvic floor muscle exercise
Group receives standardized written and verbal instructions on how to perform PFME and are asked to perform the pelvic floor muscle exercises 3 times per day, with 15 repetitions per set, daily for 6 weeks. Women perform PFME at an intensity of at least 65-75% of one repetition maximum. (Repetition maximum load is the maximum weight or force an individual can exert in a single lift.) In addition participants receive placebo food supplement to take once a day.

Locations

Country	Name	City	State
Hungary	Dr. Secret Private Clinic	Debrecen	HB

Sponsors (1)

Lead Sponsor	Collaborator
FEMPHARMA Kft.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UDI-6 score	Comparison of Urogenital Distress Inventory-6 (UDI-6) questionnaire final scores before and after treatment in the two arms.	6 weeks
Secondary	Incontinence Impact Questionnaire (IIQ-7) score	Comparison of Incontinence Impact Questionnaire (IIQ-7) questionnaire final scores before and after treatment in the two arms.	6 weeks
Secondary	Patient's Global Impression of Severity (PGI-S)	Comparison of Patient's Global Impression of Severity (PGI-S) questionnaire final scores before and after treatment in the two arms.	6 weeks
Secondary	Patient's Global Impression of Improvement (PGI-I)	Patients will be asked answer the PGI-I questionnaire after the 6 week course of therapy.	6 weeks
Secondary	Vaginal Tactile Imager (VTI) score	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.	6 weeks
Secondary	Vaginal squeeze pressure	Pelvic muscle contraction will be measured at week 0 and week 6 using a pelvic perineometer to assess any improvement in pelvic muscle strength.	6 weeks