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

NCT05358769 | Completed

• 1 other identifier: 2022INCOXIL
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incontinence Impact Questionnaire (IIQ-7) score

  6 weeks

• Patient's Global Impression of Severity (PGI-S)

  6 weeks

• Patient's Global Impression of Improvement (PGI-I)

  6 weeks

• Vaginal Tactile Imager (VTI) score

  6 weeks

• Vaginal squeeze pressure

  6 weeks

Study Arms (2)

Incoxil supplement group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Other: Pelvic floor muscle exercise

Interventions

Incoxil food supplement and pelvic floor muscle exercise DIETARY_SUPPLEMENT

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.

Incoxil supplement group

Pelvic floor muscle exercise OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• FEMPHARMA Kft.: lead

Study Sites (1)

Dr. Secret Private Clinic

Debrecen, HB, 4032, Hungary

Location

Related Publications (1)

• Takacs P, Pakozdy K, Koroknai E, Erdodi B, Krasznai Z, Kozma B. A randomized controlled pilot trial to assess the effectiveness of a specially formulated food supplement and pelvic floor muscle training in women with stress-predominant urinary incontinence. BMC Womens Health. 2023 Jun 20;23(1):321. doi: 10.1186/s12905-023-02476-z.

  PMID: 37340306 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bence Kozma, MD PhD

  Dr. Secret Private Clinic Debrecen Hungary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 3, 2022
• Study Start: April 27, 2022
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)