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

2026年10月10日 更新者：FEMPHARMA Kft.

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：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.
其他：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.
实验性的：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.
膳食补充剂：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
UDI-6
大体时间：12-weeks

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

FEMPHARMA Kft.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年9月29日

首先提交符合 QC 标准的

2026年9月29日

首次发布 (实际的)

2026年10月5日

研究记录更新

最后更新发布 (实际的)

2026年10月15日

上次提交的符合 QC 标准的更新

2026年10月10日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2026INCOXIL

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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