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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Dietary supplement: Incoxil food supplement and pelvic floor muscle exercise; Other: Pelvic floor muscle exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • HB
    • Debrecen, HB, Hungary, 4032
      • Dr. Secret Private Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Incoxil supplement group; Incoxil supplement-group: receive daily oral Incoxil supplementation and perform pelvic floor muscle exercise (PFME) for 6 weeks.	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.
Active Comparator: Control group; Control group: receive placebo oral daily supplementation and perform pelvic floor muscle exercise (PFME) for 6 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: FEMPHARMA Kft.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): September 9, 2022

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: 2022INCOXIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No