Effect of Pelvic Floor Muscle Training Combined With Dietary Supplementation on Urinary Incontinence and Pelvic Floor Muscle Function in Women

Pelvic floor muscle training (PFMT) is commonly used in the conservative management of urinary incontinence. The aim of the study is to investigate changes in urinary incontinence symptoms and pelvic floor muscle function during a treatment program involving pelvic floor muscle exercises and the use of a dietary supplement.

The study includes women suffering from stress, urge, or mixed urinary incontinence. Participants undergo a baseline assessment followed by follow-up visits after 4 weeks and 12 weeks.

At the baseline visit, demographic and medical information is collected, including age, chronic diseases, regularly used medications, height, weight, pregnancy and delivery history, menopausal status, and previous surgical procedures.

Urinary incontinence symptoms are assessed using the Medical, Epidemiologic and Social Aspects of Aging (MESA) questionnaire. Participants also complete the Patient Global Impression of Severity (PGI-S), the Incontinence Impact Questionnaire short form (IIQ-7), the Urinary Distress Inventory short form (UDI-6), and the SF-12 Health Survey.

Pelvic floor and pelvic organ status are evaluated using Vaginal Tactile Imaging (VTI), the Pelvic Organ Prolapse Quantification (POP-Q) system, perineometer measurements, and manual assessment of pelvic floor muscle strength using the Oxford scale. Three perineometer measurements are recorded.

Participants receive the dietary supplement as well as a urinary diary and instructions and a diary for pelvic floor muscle exercises.

At the second visit, performed after 4 weeks, participants complete the Patient Global Impression of Improvement (PGI-I), IIQ-7, and UDI-6 questionnaires to assess changes in symptoms and their impact on daily activities and quality of life.

The third visit is performed after 12 weeks. Participants again complete the PGI-I, IIQ-7, and UDI-6 questionnaires. Pelvic floor and pelvic organ assessments are repeated, including Vaginal Tactile Imaging, POP-Q assessment, three perineometer measurements, and manual evaluation of pelvic floor muscle strength using the Oxford scale.

Changes in urinary incontinence symptoms, quality of life, patient-reported improvement, and objective pelvic floor muscle parameters are evaluated over the 12-week study period.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress Incontinence Female
• Intervention / Treatment: Other: Placebo Control; Dietary supplement: Incoxil

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbara Kozma, MD; Phone Number: +36202633069; Email: kozma.barbara@med.unideb.hu

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:

• Female participants aged 18 years or older.
• Diagnosis of stress, urge, or mixed urinary incontinence.
• Residence geographically close enough to the study site to allow regular attendance at in-person study visits.
• Ability and willingness to provide written informed consent.

Exclusion Criteria:

• Pregnancy or postpartum status within 12 months after delivery.
• More than three vaginal deliveries or any previous operative delivery, including cesarean section, vacuum-assisted delivery, or forceps delivery.
• Symptomatic pelvic organ prolapse or POP-Q stage greater than II.
• Supervised pelvic floor muscle training within the previous 12 months.
• Current pharmacological treatment for urinary incontinence, including anticholinergic agents or β3-agonists.
• Known or suspected connective tissue disease, including Ehlers-Danlos syndrome or Marfan syndrome.
• Known zinc or copper deficiency, or hypersensitivity to these trace elements.
• Previous pelvic or gynecological surgery that may influence study outcomes.
• Active urogenital infection or acute inflammatory condition at the time of enrollment.
• Neurological disease that may affect pelvic floor muscle function or urinary continence, including multiple sclerosis or peripheral neuropathy.
• Severe psychiatric disease or cognitive impairment that may prevent reliable completion of study questionnaires.
• Inability or unwillingness to attend required study visits, including geographical limitations preventing regular in-person participation.
• Failure to provide written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants in this arm will perform pelvic floor muscle training (PFMT) daily and will receive the control/placebo dietary supplement daily for 12 weeks. Clinical symptoms, quality of life, and pelvic floor muscle function will be assessed at baseline and during follow-up visits.	Other: Placebo Control; Participants in the placebo group will receive a placebo dietary supplement designed to match the active dietary supplement in appearance and administration schedule but without the active ingredients. Participants will also follow the same pelvic floor muscle training (PFMT) program as the intervention group throughout the 12-week study period. Clinical symptoms, quality of life, and pelvic floor muscle function will be assessed at baseline and during follow-up visits.
Experimental: Incoxil; Participants in this arm will perform pelvic floor muscle training (PFMT) daily and will take the Incoxil dietary supplement daily for 12 weeks. Clinical symptoms, quality of life, and pelvic floor muscle function will be assessed at baseline and during follow-up visits.	Dietary supplement: Incoxil; Participants will receive a dietary supplement in combination with a structured pelvic floor muscle training (PFMT) program. The intervention is intended to support pelvic floor muscle function and improve symptoms of urinary incontinence. Participants will perform PFMT regularly throughout the 12-week study period and will use the dietary supplement according to the study protocol. Clinical symptoms, quality of life, and pelvic floor muscle function will be assessed at baseline and at follow-up visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UDI-6	Change in urinary incontinence symptom burden as measured by the Urinary Distress Inventory-6 (UDI-6). The UDI-6 scale ranges from a minimum of 0 to a maximum of 24, with higher scores indicating more severe symptoms. The primary outcome will be the change in total UDI-6 score from baseline to the end of the 12-week study period. A greater reduction in UDI-6 score indicates greater improvement in urinary symptoms.	12-weeks

Collaborators and Investigators

• Sponsor: FEMPHARMA Kft.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 29, 2026
• First Submitted That Met QC Criteria: September 29, 2026
• First Posted (Actual): October 5, 2026

Study Record Updates

• Last Update Posted (Actual): October 15, 2026
• Last Update Submitted That Met QC Criteria: October 10, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026INCOXIL

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