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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04950556
• Other study ID #: 2021/06/27
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: August 2022

Study information

• Verified date: June 2021
• Source: Ataturk Training and Research Hospital
• Contact: Seyda Toprak Celenay
• Phone: +90312 906 1000
• Email: sydtoprak[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Other:
• Exercise
Pelvic floor muscle exercise will be given to the exercise group
• Control
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Urinary frequency, nocturia and the number of urinary incontinence	Patients will be also instructed to keep voiding diary	change from baseline at 6 weeks
Secondary	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