Clinical trial NCT05358769: A Study of Incoxil Food Supplement in Female Patients With Stress Dominant Urinary Incontinence.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: FEMPHARMA Kft.
Sponsor class: INDUSTRY
First posted: 2022-05-03
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: UDI-6 score
timeFrame: 6 weeks
Secondary outcomes:
measure: Incontinence Impact Questionnaire (IIQ-7) score
timeFrame: 6 weeks
measure: Patient's Global Impression of Severity (PGI-S)
timeFrame: 6 weeks
measure: Patient's Global Impression of Improvement (PGI-I)
timeFrame: 6 weeks
measure: Vaginal Tactile Imager (VTI) score
timeFrame: 6 weeks
measure: Vaginal squeeze pressure
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Debrecen
country: Hungary
facility: Dr. Secret Private Clinic
state: HB
Study officials:
affiliation: Dr. Secret Private Clinic Debrecen Hungary
name: Bence Kozma, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: