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

NCT05358769 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-02-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • FEMPHARMA Kft.

    lead INDUSTRY

Principal Investigators

  • Bence Kozma, MD PhD · Dr. Secret Private Clinic Debrecen Hungary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2022-09-09
Completion
2022-09-09

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05358769 on ClinicalTrials.gov