Effects of Spinal Stabilization Exercises Focusing on the Pelvic Floor in Women With Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

Investigation of the Effects of Spinal Stabilization Exercises Focusing on the Pelvic Floor in Women With Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05677841
• Other study ID #: 2022/12/23
• Status: Completed
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: May 25, 2023

Study information

• Verified date: July 2023
• Source: Ankara Yildirim Beyazit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to examine the effects of spinal stabilization exercises focusing on the pelvic floor on urinary symptoms, spinal stability, pelvic floor muscle functions, quality of life and perception of recovery in women with overactive bladder.

Description:

Overactive bladder (OAB) is defined by the International Continence Society and the International Society of Urogynecology as urinary urgency with or without urinary incontinence, usually accompanied by frequency and nocturia. Among the treatment options of OAB; first-line treatments include lifestyle recommendations, exercise approaches, and bladder training. Lifestyle recommendations; healthy lifestyle includes behavioral changes. Spinal stabilization exercise also aims to improve the neuromuscular control, strength and endurance of the muscles that are important in maintaining trunk stability. In recent years, it has been stated that trunk stability is impaired in women with OAB. However, no study was found on spinal stabilization exercises in patients with OAB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 25, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Being between the ages of 18-65

• Women with a diagnosis of overactive bladder

• Women who volunteered to participate in the study

Exclusion Criteria:

• Women with only stress urinary incontinence

• Presence of advanced pelvic organ prolapse

• Having a mental problem that will prevent cooperation in assessment and/or practices

• Women with the presence of a malignant condition

• Concomitant neurological disease and/or neurogenic bladder

• Presence of infection

• Pregnancy

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Other:
• Stabilization exercise+lifestyle recommendation
Exercise program was given both spinal stabilization exercises focusing on the pelvic floor 3 days a week for eight weeks and a booklet related to the lower urinary system symptoms, the structure of the pelvic floor and healthy behavioral strategies recommendations (fluid intake, diet, weight control etc. )
• lifestyle recommendations
The control group will be given a booklet related to the lower urinary system symptoms, the structure of the pelvic floor and healthy behavioral strategies recommendations (fluid intake, diet, weight control etc. )

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University	Ankara	Esenboga Külliyesi

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overactive bladder symptoms	The Overactive Bladder Questionnaire -V8 will be used for the overactive bladder symptoms severity. It has 8 items and the total score can range from 0 to 40. As the score increases, the severity of symptoms increases.	change from baseline at 8 weeks
Secondary	Bladder function	Voiding dairy will be used to evaluate the bladder function. In the diary, women will be asked to record some parameters such as voiding time and volume, number of UI, and the amount and type of fluid intake.	change from baseline at 8 weeks
Secondary	Urgency severity	Patients' Perception of Intensity of Urgency Scale will be used to evaluate urgency severity.; According to this scale, "0" means no sense of urgency, "1" means mild urge to urinate, "2" means moderate urge to urinate, "3" means severe urge to urinate, and "4" means urge type incontinence.	change from baseline at 8 weeks
Secondary	Spinal stability	The Sharman test will be used to evaluate spinal stability. In this test, the inflatable pad of a pressure biofeedback unit was placed in the natural lordotic curve of the back and was inflated to 40mmHg whilst the subject is lying supine. The subject will be activated the stabilising musculature via the abdominal bracing technique and then the participants will be asked to bring their leg to different positions. The test consists of five levels with each level increasing in difficulty.	change from baseline at 8 weeks
Secondary	Pelvic floor muscle function	Digital palpation will be used to evaluate pelvic floor muscle function while woman will be in the lithotomy position. Index + middle fingers will be inserted into the vagina.The women will be asked to squeeze these fingers in her vagina. force, endurance and speed parameters will be recorded.	change from baseline at 8 weeks
Secondary	Life Quality	King's Health Questionnaire will be used to evaluate life quality. It includes 9 sub-dimensions (General Health Perception, Incontinence Impact, Role Limitation, Physical Limitation, Social Limitation, Personal Limitation, Sleep/Energy Disturbance, Emotional Problems, and Severity Measures related UI). These sub-domains scores range from 0 to 100, where higher scores of indicate greater impairment in life quality	change from baseline at 8 weeks
Secondary	Perception of Recovery	A 4-item Likert-type scale (worse, same, better, cured) will be used to evaluate perception of recovery	after treatment (8th week)
Secondary	Compliance with recommendation	Visual Analog Scale will be used to evaluate the compliance with recommendation.Participants were asked to rate compliance with recommendation on a 10 cm VAS line from 0 (not following recommendations at all) to 10 (completely following recommendations).	after treatment (8th week)