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

Not Applicable

Completed

• Conditions: Overactive Bladder
• Interventions: Other: Stabilization exercise+lifestyle recommendation; Other: lifestyle recommendations

• Registration Number: NCT05677841
• Lead Sponsor: Ankara Yildirim Beyazıt University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-12-29
• Study First Submitted QC: 2022-12-29
• Study First Posted: 2023-01-10
• Study Start: 2023-01-15
• Primary Completion: 2023-03-15
• Study Completion: 2023-05-25
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise group	Stabilization exercise+lifestyle recommendation	Exercise group will be given spinal stabilization exercises focusing on the pelvic floor and lifestyle reccommendations
Control group	lifestyle recommendations	Control group will be given lifestyle recommendations

Primary Outcome Measures

Name	Time	Method
Overactive bladder symptoms	change from baseline at 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Urgency severity	change from baseline at 8 weeks	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.
Spinal stability	change from baseline at 8 weeks	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.
Bladder function	change from baseline at 8 weeks	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.
Perception of Recovery	after treatment (8th week)	A 4-item Likert-type scale (worse, same, better, cured) will be used to evaluate perception of recovery
Compliance with recommendation	after treatment (8th week)	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).
Life Quality	change from baseline at 8 weeks	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
Pelvic floor muscle function	change from baseline at 8 weeks	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.

Trial Locations

Locations (1)

Ankara Yıldırım Beyazıt University; 🇹🇷 Ankara, Esenboğa Külliyesi, Turkey