Clinical trial NCT06581601: Physiotherapy Management in Women With Urinary Incontinence
Official title: Physiotherapy Management in Women With Urinary Incontinence Considering Postural Stability, Postural Pattern, Pelvic Type, Quality of Life, and Sexual Aspect
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Keywords: the author's exercise program
urinary incontinence
physiotherapy
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Pre- and post-menopause group perform author's exercise program.
Primary purpose: PREVENTION

Brief summary: 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).

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

Primary outcomes:
measure: Modified 1-Hour Pad Test, measurement in grams
timeFrame: before start exercises and after six week finish exercises
measure: Floor Disability Index
timeFrame: before start exercises and after six week finish exercises
measure: Pelvic Floor Impact Questionnaire Short Form
timeFrame: before start exercises and after six week finish exercises
measure: Sexual Satisfaction Scale
timeFrame: before start exercises and after six week finish exercises
measure: Neck Disability Pain Index
timeFrame: before start exercises and after six week finish exercises
measure: Revised Oswestry Low Back Pain Disability Scale
timeFrame: before start exercises and after six week finish exercises
measure: Migraine Disability Assessment
timeFrame: before start exercises and after six week finish exercises
measure: Hospital Anxiety and Depression Scale
timeFrame: before start exercises and after six week finish exercises
measure: Short Form McGill Pain Questionnaire
timeFrame: before start exercises and after six week finish exercises
measure: CRANIA (Integrated Approach to Cranio Mandibular Neuroscience) questionnaire
timeFrame: before start exercises and after six week finish exercises
measure: International Physical Activity Questionnaire
timeFrame: before start exercises and after six week finish exercises
measure: Posture type Assessment by Hall-Wernham-Littlejohn, The result based on the observation of the posture with the use of the vertical, there is no measure or unit here.
timeFrame: before start exercises
measure: Pelvic Type Assessment, result based on the evaluation of the height of the hip plates relative to the L4/L5 vertebra, there is no measure or unit here.
timeFrame: before start exercises
Secondary outcomes:
measure: Postural stability assessment, measurement in the form of a number, the manufacturer does not provide measurement units.
timeFrame: before start exercises and after six week finish exercises
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: 1Department of Physiotherapy, Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow Wlkp., 61-871 Poznan
Study officials:
affiliation: Student Research Centre Conocimiento, Faculty of Sport Sciences in Gorzow Wielkopolski
name: Agata Wojtczak
role: PRINCIPAL_INVESTIGATOR
References: