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

NCT07859241 | Not Yet Recruiting

• 1 other identifier: 2026INCOXIL
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stress Incontinence Female

Outcome Measures

Primary Outcomes (1)

• UDI-6

  Change in urinary incontinence symptom burden as measured by the Urinary Distress Inventory-6 (UDI-6). 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

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Intervention group

EXPERIMENTAL

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

Interventions

Incoxil DIETARY_SUPPLEMENT

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.

Intervention group

Placebo Control OTHER

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.

Control group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FEMPHARMA Kft.: lead

Central Study Contacts

Barbara Kozma, MD

CONTACT

+36202633069; kozma.barbara@med.unideb.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2026
• First Posted: October 5, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 5, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share