Physiotherapy Management in Women With Urinary Incontinence

NCT ID: NCT06581601

Last Updated: 2024-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2027-11-20

Brief Summary

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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

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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).

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Pre- and post-menopause group perform author's exercise program.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

1.Contorl group: healtyhy women.

Group Type NO_INTERVENTION

No interventions assigned to this group

Pre-menopausal group

2.Pre-menopasal group: experimental group - exercise's group

Group Type EXPERIMENTAL

physiotherapy, exercises

Intervention Type OTHER

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 Floor Impact Questionnaire Short Form (PFIQ-7 SF), Sexual Satisfaction Scale (SSS-W-R15), Neck Disability Pain Index, Revised Oswestry Low Back Pain Disability Scale, Migraine Disability Assessment (MIDAS), Hospital Anxiety and Depression Scale (HADS), Short Form McGill Pain Questionnaire, CRANIA (Integrated Approach to Cranio Mandibular Neuroscience) questionnaire, IPAQ (International Physical Activity Questionnaire). Modified 1-Hour Pad Test. Execution of the Author's Training Program.

Post-menopausal group

3.Post-menopausal group: experimental group - exercise's group

Group Type EXPERIMENTAL

physiotherapy, exercises

Intervention Type OTHER

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 Floor Impact Questionnaire Short Form (PFIQ-7 SF), Sexual Satisfaction Scale (SSS-W-R15), Neck Disability Pain Index, Revised Oswestry Low Back Pain Disability Scale, Migraine Disability Assessment (MIDAS), Hospital Anxiety and Depression Scale (HADS), Short Form McGill Pain Questionnaire, CRANIA (Integrated Approach to Cranio Mandibular Neuroscience) questionnaire, IPAQ (International Physical Activity Questionnaire). Modified 1-Hour Pad Test. Execution of the Author's Training Program.

Interventions

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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 Floor Impact Questionnaire Short Form (PFIQ-7 SF), Sexual Satisfaction Scale (SSS-W-R15), Neck Disability Pain Index, Revised Oswestry Low Back Pain Disability Scale, Migraine Disability Assessment (MIDAS), Hospital Anxiety and Depression Scale (HADS), Short Form McGill Pain Questionnaire, CRANIA (Integrated Approach to Cranio Mandibular Neuroscience) questionnaire, IPAQ (International Physical Activity Questionnaire). Modified 1-Hour Pad Test. Execution of the Author's Training Program.

Intervention Type OTHER

Other Intervention Names

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author's exercise program

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Poznan University of Physical Education

OTHER

Sponsor Role lead

Responsible Party

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Małgorzata Wójcik

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Agata Wojtczak

Role: PRINCIPAL_INVESTIGATOR

Student Research Centre Conocimiento, Faculty of Sport Sciences in Gorzow Wielkopolski

Locations

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1Department of Physiotherapy, Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow Wlkp., 61-871 Poznan

Poznan, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Małgorzata Wójck, PhD PT

Role: CONTACT

+489572 79 100 ext. 121

Facility Contacts

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Małgorzata Wójcik, PhD

Role: primary

Other Identifiers

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2024

Identifier Type: -

Identifier Source: org_study_id

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