Physiotherapy Management in Women With Urinary Incontinence

NCT06581601 | Recruiting DMC

• 1 other identifier: 2024
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

the author's exercise program; urinary incontinence; physiotherapy

Outcome Measures

Primary Outcomes (13)

• 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.

  before start exercises and after six week finish exercises

• 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.

  before start exercises and after six week finish exercises

• 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.

  before start exercises and after six week finish exercises

• 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.

  before start exercises and after six week finish exercises

• 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.

  before start exercises and after six week finish exercises

• 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.

  before start exercises and after six week finish exercises

• 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.

  before start exercises and after six week finish exercises

• 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.

  before start exercises and after six week finish exercises

• 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.

  before start exercises and after six week finish exercises

• 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.

  before start exercises and after six week finish exercises

• 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.

  before start exercises and after six week finish exercises

• 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.

  before start exercises

• 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.

  before start exercises

Secondary Outcomes (1)

• Postural stability assessment, measurement in the form of a number, the manufacturer does not provide measurement units.

  before start exercises and after six week finish exercises

Study Arms (3)

Control group

NO INTERVENTION

1.Contorl group: healtyhy women.

Pre-menopausal group

EXPERIMENTAL

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

Other: physiotherapy, exercises

Post-menopausal group

EXPERIMENTAL

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

Other: physiotherapy, exercises

Interventions

physiotherapy, exercises 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.

Also known as: author's exercise program

Post-menopausal group; Pre-menopausal group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

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

Poznan, 61-871, Poland

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Physical Therapy Modalities; Exercise

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Agata Wojtczak

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Małgorzata Wójck, PhD PT

CONTACT

+489572 79 100; m.wojcik@awf-gorzow.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: Pre- and post-menopause group perform author's exercise program.

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: September 3, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): November 20, 2027
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)