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Urinary IncontinenceNCT06581601

Physiotherapy Management in Women With Urinary Incontinence

A study testing physiotherapy, exercises in people with Urinary Incontinence, run by Poznan University of Physical Education at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for
Urinary Incontinence
What is being tested?
physiotherapy, exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 sitePoland
Study dates
21 Aug 2024to 20 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Małgorzata Wójck, PhD PT contact

+489572 79 100 ext. 121

m.wojcik@awf-gorzow.edu.pl

Poland1 site, 1 recruiting
  • 1Department of Physiotherapy, Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow Wlkp., 61-871 Poznan

    Poznan, 61-871

    Małgorzata Wójcik, PhD, m.wojcik@awf-gorzow.edu.pl

    Recruiting

Other trials in Poland

About this study

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

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.

Read the 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).
Being tested
physiotherapy, exercises
Keywords
the author's exercise program, urinary incontinence, physiotherapy
Medical subject headings
Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • physiotherapy, exercisesOther

    Also called author's exercise program

    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.

Study groups in NCT06581601
Study groupRoleWhat they receive
Control groupNo intervention1.Contorl group: healtyhy women.
Pre-menopausal groupExperimental2.Pre-menopasal group: experimental group - exercise's group
Receives: Other: physiotherapy, exercises
Post-menopausal groupExperimental3.Post-menopausal group: experimental group - exercise's group
Receives: Other: physiotherapy, exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified 1-Hour Pad Test, measurement in grams

    Before starting the author's six-week exercise program and after its completion, a modified 1-hour PAD Test will be conducted, which involves checking the amount of urine lost, during strictly defined activities. The test follows the guidelines in the literature. The test subject puts on a pre-weighed pad and, after emptying the bladder, drinks 500ml of water over 15 minutes. The test subject then waits 30 minutes. After this time, the test begins with 15 minutes of walking and climbing stairs. The test subject then performs a special training program: 10 times she stands up and sits down on a chair, 10 times she coughs vigorously, 10 times she picks up a bottle of water from the ground, runs in place for 1 minute, and for

    1 minute he holds his hands under running water. After the test is completed, the pad is weighed again and the amount of urine lost during the test is assessed.

    Measured: before start exercises and after six week finish exercises

  2. Floor Disability Index

    Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score.

    Measured: before start exercises and after six week finish exercises

  3. Pelvic Floor Impact Questionnaire Short Form

    Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score.

    Measured: before start exercises and after six week finish exercises

  4. Sexual Satisfaction Scale

    Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score.

    Measured: before start exercises and after six week finish exercises

  5. Neck Disability Pain Index

    Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score.

    Measured: before start exercises and after six week finish exercises

  6. Revised Oswestry Low Back Pain Disability Scale

    Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score.

    Measured: before start exercises and after six week finish exercises

  7. Migraine Disability Assessment

    Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score.

    Measured: before start exercises and after six week finish exercises

  8. Hospital Anxiety and Depression Scale

    Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score.

    Measured: before start exercises and after six week finish exercises

  9. Short Form McGill Pain Questionnaire

    Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score.

    Measured: before start exercises and after six week finish exercises

  10. CRANIA (Integrated Approach to Cranio Mandibular Neuroscience) questionnaire

    Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score.

    Measured: before start exercises and after six week finish exercises

  11. International Physical Activity Questionnaire

    Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The higher the value of the points received, the better the score.

    Measured: before start exercises and after six week finish exercises

  12. 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.

    Type I correct: The examinee stands sideways, the plumb line is applied to the mastoid process of the temporal bone, correctly the plumb line runs along the cervical segment, through the middle of the shoulder, knee joint. For the front type II, the measurement is taken as before but the head is extended forward, the vertical course.Anterior pelvic tilt is still observed. With the rear type III, measurement as before. The vertical does not go through the center of the shoulder and knee. A posterior tilt of the pelvis, a rounded back and a receding head are observed.

    Measured: before start exercises

  13. 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.

    The subject is standing and the examiner must identify the fourth and fifth lumbar vertebrae. Pelvic assessment is carried out according to Lewitt. Pelvis normal: If the iliac crests are at the height of the fourth and fifth lumbar vertebrae.The pelvis is highly assimilated when the iliac crests fall above the fourth and fifth lumbar vertebrae.Pelvic overload when the iliac crests fall below the fourth and fifth lumbar vertebrae.

    Measured: before start exercises

Secondary outcomes (1)
  1. Postural stability assessment, measurement in the form of a number, the manufacturer does not provide measurement units.

    Posturomed stablometric platform will be used to assess postural stability. Posturomed stablometric platform will be used to assess postural stability

    Measured: before start exercises and after six week finish exercises

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2024
  2. Study start21 Aug 2024
  3. Primary completion20 Nov 2027 (estimated)
  4. Study completion20 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Factorial
Model description
Pre- and post-menopause group perform author's exercise program.
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06581601
Sponsor's protocol ID
2024
Status last verified
Sep 2026
First submitted
18 Aug 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 1. gathered groups. 2. pre-exercise evaluation. 3. exercises. 4. post-exercise evaluation. 5. Statistical compilation of data. 6. Presentation of results at scientific conferences and in a scientific journal as a publication.

Questions about this trial

What is this clinical trial studying?

A study testing physiotherapy, exercises in people with Urinary Incontinence, run by Poznan University of Physical Education at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Małgorzata Wójck, PhD PT (+489572 79 100 ext. 121, m.wojcik@awf-gorzow.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified 1-Hour Pad Test, measurement in grams (time frame: before start exercises and after six week finish exercises). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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