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

Not Applicable

• Conditions: Overactive Bladder
• Interventions: Other: Control; Other: Exercise

• Registration Number: NCT04950556
• Lead Sponsor: Ataturk Training and Research Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-06-27
• Last Update Submitted: 2021-06-27
• Study Start: 2021-07
• Study First Posted: 2021-07-06
• Last Update Posted: 2021-07-06
• Primary Completion: 2022-07
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control	Waiting list will included in control group.
Exercise group	Exercise	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.

Primary Outcome Measures

Name	Time	Method
Pelvic floor muscle strength	change from baseline at 6 weeks	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
Sexual Function	change from baseline at 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Urinary frequency, nocturia and the number of urinary incontinence	change from baseline at 6 weeks	Patients will be also instructed to keep voiding diary
Life quality	change from baseline at 6 weeks	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).
OAB symptoms	change from baseline at 6 weeks	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.