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RecruitingNCT06581601Updated Sep 24, 2026

Physiotherapy Management in Women With Urinary Incontinence

An interventional study of physiotherapy, exercises in Urinary Incontinence, sponsored by Poznan University of Physical Education. Recruiting at 1 site in Poland. Open to female participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Poznan University of Physical Education · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
20 Years to 80 Years
Sex
Female
01

Study 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.

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).
02

Conditions studied

  • Urinary Incontinence

Keywords

  • the author's exercise program
  • urinary incontinence
  • physiotherapy
03

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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

04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • No intervention
    Control group

    1.Contorl group: healtyhy women.

  • Experimental
    Pre-menopausal group

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

    Other: physiotherapy, exercises

  • Experimental
    Post-menopausal group

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

    Other: physiotherapy, exercises

Interventions

  • Otherphysiotherapy, 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.

    Also known as: author's exercise program

05

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: before start exercises

Secondary outcomes

  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

    Time frame: before start exercises and after six week finish exercises

06

Study locations

1 of 1 sites recruiting
  • 1Department of Physiotherapy, Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow Wlkp., 61-871 Poznan
    Poznan, 61-871, Poland
    Recruiting
07

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06581601
Lead sponsor
Poznan University of Physical Education
Responsible party
Małgorzata Wójcik (doctor, Poznan University of Physical Education) — Principal investigator
First posted
Sep 3, 2024
Start date
Aug 21, 2024
Primary completion
Nov 20, 2027 (estimated)
Completion
Nov 20, 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

Małgorzata Wójck, PhD PT
Contact
m.wojcik@awf-gorzow.edu.pl
+489572 79 100 ext. 121
Agata Wojtczak
principal investigator · Student Research Centre Conocimiento, Faculty of Sport Sciences in Gorzow Wielkopolski

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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