Urinary IncontinenceNCT05358769
A Study of Incoxil Food Supplement in Female Patients With Stress Dominant Urinary Incontinence.
A study testing Incoxil food supplement and pelvic floor muscle exercise and Pelvic floor muscle exercise in people with Urinary Incontinence, run by FEMPHARMA Kft. at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Incoxil food supplement and pelvic floor muscle exercise and Pelvic floor muscle exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteHungary
- Study dates
- 27 Apr 2022to 9 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stress UI or stress-dominant mixed UI (stress percent score more than urge percent score)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- Incoxil food supplement and pelvic floor muscle exercise, Pelvic floor muscle exercise
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incoxil food supplement and pelvic floor muscle exerciseDietary 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.
Pelvic floor muscle exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Incoxil supplement group | Experimental | Incoxil supplement-group: receive daily oral Incoxil supplementation and perform pelvic floor muscle exercise (PFME) for 6 weeks. Receives: 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. Receives: Other: Pelvic floor muscle exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
UDI-6 score
Comparison of Urogenital Distress Inventory-6 (UDI-6) questionnaire final scores before and after treatment in the two arms.
Measured: 6 weeks
Secondary outcomes (5)
Incontinence Impact Questionnaire (IIQ-7) score
Comparison of Incontinence Impact Questionnaire (IIQ-7) questionnaire final scores before and after treatment in the two arms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start27 Apr 2022
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- FEMPHARMA Kft.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bence Kozma, MD PhD, Principal investigator, Dr. Secret Private Clinic Debrecen Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358769
- Sponsor's protocol ID
- 2022INCOXIL
- Status last verified
- Feb 2023
- First submitted
- 28 Apr 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37340306
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05358769
- Acronym / sponsor ID
- 2022INCOXIL
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- FEMPHARMA Kft.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incoxil supplement group | Experimental | Dietary Supplement: Incoxil food supplement and pelvic floor muscle exerciseIncoxil supplement-group: receive daily oral Incoxil supplementation and perform pelvic floor muscle exercise (PFME) for 6 weeks. |
| Control group | Active comparator | Other: Pelvic floor muscle exerciseControl group: receive placebo oral daily supplementation and perform pelvic floor muscle exercise (PFME) for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stress UI or stress-dominant mixed UI (stress percent score more than urge percent score)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incoxil food supplement and pelvic floor muscle exerciseIncoxil 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. | Dietary supplement | Incoxil supplement group |
| Pelvic floor muscle exerciseGroup 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. | Other | Control group |
Primary outcome
UDI-6 score
Time frame: 6 weeks
Comparison of Urogenital Distress Inventory-6 (UDI-6) questionnaire final scores before and after treatment in the two arms.
5 secondary outcomes
Incontinence Impact Questionnaire (IIQ-7) score
Time frame: 6 weeks
Patient's Global Impression of Severity (PGI-S)
Time frame: 6 weeks
Patient's Global Impression of Improvement (PGI-I)
Time frame: 6 weeks
Vaginal Tactile Imager (VTI) score
Time frame: 6 weeks
Vaginal squeeze pressure
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Derived from this study: PubMed 37340306Takacs 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bence Kozma, MD PhD principal investigator
Dr. Secret Private Clinic Debrecen Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incoxil food supplement and pelvic floor muscle exercise and Pelvic floor muscle exercise in people with Urinary Incontinence, run by FEMPHARMA Kft. at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UDI-6 score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05358769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.