Menu
Recruiting NCT06581601

Physiotherapy Management in Women With Urinary Incontinence

No phase Interventional Urinary Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: physiotherapy, exercises.
Who it may be relevant to
Registry conditions: Urinary Incontinence. Basic parameters: 20 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Physiotherapy Management in Women With Urinary Incontinence Considering Postural Stability, Postural Pattern, Pelvic Type, Quality of Life, and Sexual Aspect

Overview

Main objective: The primary aim of the study is to assess whether the author's exercise programme has an effect on reducing urinary incontinence and pelvic floor dysfunction after childbirth, considering vacuum extractor, forceps and caesarean section deliveries. Secondary objective: The secondary objective is to determine whether the duration of the author's exercise programme is sufficient to achieve positive changes in women.

Detailed description

The study will involve women with stress urinary incontinence, urge urinary incontinence, and mixed urinary incontinence. Participants will be women aged 20-80 years (meeting inclusion criteria: urinary incontinence, regular menstrual cycles, pre-and post menopausal period, natural childbirth or cesarean section, and deliveries using forceps and vacuum extractors; exclusion criteria: no urinary incontinence, irregular menstrual cycles, no childbirth, abdominal surgeries/procedures, active cancer, no gynecological check-up in the last 12 months, recurrent urogenital infections, joint hypermobility). A total of 300 women will be examined, including 100 women meeting the inclusion criteria, 100 women meeting the inclusion criteria but not interested in exercising, and 100 healthy women. Participants can withdraw from the study at any stage.Study Group Division

Based on the evaluation of posture type, pelvic pattern, and postural stability, participants will be divided into three groups:

1. Women meeting inclusion criteria performing the author's exercise program - experimental group. 2. Women meeting inclusion criteria but not interested in performing the author's exercise program - control group. 3. Healthy women - control group. The experimental group will perform the author's pelvic floor muscle exercise program daily for six weeks, at a fixed time each day, under weekly physiotherapist supervision and independently on other days (after proper instruction by the physiotherapist).

Interventions

  • Other physiotherapy, exercises
    An author's questionnaire will be used for participant selection, asking about the number and course of deliveries. Additionally, participants will log daily activities to calculate the physical activity level coefficient. Weight and height will be measured using a Tanita device to calculate BMI. The posture type and pelvic type will be assessed. Participants will be asked to complete the following questionnaires before and after the intervention: Pelvic Floor Disability Index (PFDI-20), Pelvic

Primary outcome measures

  • Modified 1-Hour Pad Test, measurement in grams [Time frame: before start exercises and after six week finish exercises]
  • Floor Disability Index [Time frame: before start exercises and after six week finish exercises]
  • Pelvic Floor Impact Questionnaire Short Form [Time frame: before start exercises and after six week finish exercises]
  • Sexual Satisfaction Scale [Time frame: before start exercises and after six week finish exercises]
  • Neck Disability Pain Index [Time frame: before start exercises and after six week finish exercises]
  • Revised Oswestry Low Back Pain Disability Scale [Time frame: before start exercises and after six week finish exercises]
  • Migraine Disability Assessment [Time frame: before start exercises and after six week finish exercises]
  • Hospital Anxiety and Depression Scale [Time frame: before start exercises and after six week finish exercises]
  • Short Form McGill Pain Questionnaire [Time frame: before start exercises and after six week finish exercises]
  • CRANIA (Integrated Approach to Cranio Mandibular Neuroscience) questionnaire [Time frame: before start exercises and after six week finish exercises]
Secondary outcome measures (1)
  • Postural stability assessment, measurement in the form of a number, the manufacturer does not provide measurement units. [Time frame: before start exercises and after six week finish exercises]

Eligibility criteria

Inclusion criteria

  • Urinary incontinence
  • Regular menstrual cycles
  • Pre and post-menopausal period
  • Natural childbirth or cesarean section
  • Deliveries using forceps and vacuum extractors

Exclusion criteria

  • No urinary incontinence
  • Irregular menstrual cycles
  • No childbirth
  • Abdominal surgeries/procedures Active cancer No gynecological check-up in the last 12 months Recurrent urogenital infections Joint hypermobility

Contorl group will be healthy women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Factorial
Masking
Open label
Primary purpose
Prevention

Study locations

Poland · 1 center
  • 1Department of Physiotherapy, Poznan University of Physical Education, Faculty of Sport Sc — Poznan

Identifiers

NCT: NCT06581601 · 2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗