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CompletedNCT05677841Updated Jul 19, 2023

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

An interventional study of Stabilization exercise+lifestyle recommendation and lifestyle recommendations in Overactive Bladder, sponsored by Ankara Yildirim Beyazıt University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-19.

Sponsored by Ankara Yildirim Beyazıt University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

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Conditions studied

  • Overactive Bladder
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In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 40 is below the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Ankara Yildirim Beyazıt University is the lead sponsor of 228 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Exercise group

    Exercise group will be given spinal stabilization exercises focusing on the pelvic floor and lifestyle reccommendations

    Other: Stabilization exercise+lifestyle recommendation

  • Active comparator
    Control group

    Control group will be given lifestyle recommendations

    Other: lifestyle recommendations

Interventions

  • OtherStabilization 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. )

  • Otherlifestyle 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. )

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: change from baseline at 8 weeks

Secondary outcomes

  1. 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.

    Time frame: change from baseline at 8 weeks

  2. 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.

    Time frame: change from baseline at 8 weeks

  3. 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.

    Time frame: change from baseline at 8 weeks

  4. 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.

    Time frame: change from baseline at 8 weeks

  5. 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

    Time frame: change from baseline at 8 weeks

  6. Perception of Recovery

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

    Time frame: after treatment (8th week)

  7. 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).

    Time frame: after treatment (8th week)

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Study locations

1 site
  • Ankara Yıldırım Beyazıt University
    Ankara, Esenboğa Külliyesi 06760, Turkey
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05677841
Lead sponsor
Ankara Yildirim Beyazıt University
Responsible party
seyda toprak celenay (associate professor, Ankara Yildirim Beyazıt University) — Principal investigator
First posted
Jan 10, 2023
Start date
Jan 15, 2023
Primary completion
Mar 15, 2023
Completion
May 25, 2023
Last update
Jul 19, 2023

Study contacts

Seyda Toprak Celenay
principal investigator · Ankara Yildirim Beyazıt University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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