The Effects of Pelvic Floor Muscle Training in Women With Overactive Bladdder

Study Overview
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Brief Summary
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The aim of our study is to investigate the effects of pelvic floor muscle training (PFMT) on pelvic floor muscle strength, sexual functions, bladder symptoms and quality of life in women with overactive bladder (OAB).

Detailed Description
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Overactive bladder (OAB) is defined by the International Continence Association as an urgency with or without urge urinary incontinence, often accompanied by frequency and nocturia. Accordingly, pelvic floor muscle training (PFMT) plays an important role in the management of OAB. However, a recent systematic review suggests that PFMT is insufficient against OAB.

Official Title
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The Effects of Pelvic Floor Muscle Training in Women With Overactive Bladdder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Other: Exercise
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having a diagnosis of overactive bladder Being volunteer Exclusion Criteria: have a neurological disorder only those with stress urinary incontinence presence of advanced pelvic organ prolapse (stage 3-4) Having a mental problem that will prevent cooperation in evaluation and / or applications Women with the presence of malignant condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly divided into two groups (control and exercise) for treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>Fast and slow contractions will be taught in PFMT. For fast contractions, they will be asked to contract and relax the pelvic floor muscles quickly. For slow contractions, they will be asked to contract the pelvic floor muscles slowly, keep them at maximum contraction and relax slowly. Ten slow contractions in addition to 10 fast contractions will be considered as 1 set of exercises. For the first week, they will be asked to do 5 sets of exercises per day, every day. Then, the number of sets will be increased by 5 each week and the number of sets will reach 30 in the 6th week. PFMT will be applied by the patients as a home program every day of the week for 6 weeks. | Other: Exercise<br>* Pelvic floor muscle exercise will be given to the exercise group<br>|
| Other: Control group<br>Waiting list will included in control group. | Other: Control<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscle strength | The pelvic floor muscle strength of the patients will be evaluated by digital palpation. Change in pelvic floor muscle strength as measured with the Modified Oxford Scale, which ranges from 0 to 5 | change from baseline at 6 weeks | 
| Sexual Function | Female sexual function will be assessed using the Female Sexual Function Index. This 19-question questionnaire deals with the subject in a multidimensional way by questioning the states of desire, arousal, lubrication, orgasm, satisfaction and pain. The highest raw score that can be obtained from the questionnaire is 95, and the lowest raw score is 4. | change from baseline at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OAB symptoms | OAB symptoms will be evaluated OAB-V8. There are 8 questions in this form and the answers given to each question are scored between 0 and 5. The scores that can be obtained from the entire scale range from 0 to 40. | change from baseline at 6 weeks | 
| Urinary frequency, nocturia and the number of urinary incontinence | Patients will be also instructed to keep voiding diary | change from baseline at 6 weeks | 
| Life quality | Life quality will be assessed with King's Health Questionnaire (KHQ).This questionnaire consists of two parts and 32 items.. The minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health). | change from baseline at 6 weeks |