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Completed

NCT Number: NCT05677841

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

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Yıldırım Beyazıt University

Ankara, Esenboğa Külliyesi, 06760, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stabilization exercise+lifestyle recommendation

Other

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

Other

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. )

Primary outcomes

  1. Overactive bladder symptoms

    Time frame: 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 outcomes

  1. Bladder function

    Time frame: 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.

  2. Urgency severity

    Time frame: 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.

  3. Spinal stability

    Time frame: 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.

  4. Pelvic floor muscle function

    Time frame: 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.

  5. Life Quality

    Time frame: 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

  6. Perception of Recovery

    Time frame: after treatment (8th week)

    A 4-item Likert-type scale (worse, same, better, cured) will be used to evaluate perception of recovery

  7. Compliance with recommendation

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2023
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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