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Effect of BT and PFET on Urinary Symptoms and Quality of Life in Patients With OABS (OABS/BT/PFET)

H

Hacettepe University

Status

Enrolling

Conditions

Overactive Bladder Syndrome (OABS)

Treatments

Other: pelvic floor exercise
Other: bladder training
Other: Standard Patient Education

Study type

Interventional

Funder types

Other

Identifiers

NCT06209333
KA-23003

Details and patient eligibility

About

The aim of this study was to examine the effects of bladder training and pelvic floor exercise training programs given in addition to Botulinum Toxin-A (BTx-A) application on urinary symptoms and quality of life in patients with Overactive Bladder Syndrome (AAMS) who do not respond to conservative treatments.

Individuals who meet the criteria for inclusion in the study and agree to participate in the study will be divided into 2 separate research branches.The patients to be included in the study will be divided into two groups as "Group 1=Botox + physiotherapy " or "Group 2=Botox group ". In addition to the BTx-A application, bladder training and pelvic floor exercise training will be applied to patients in the first group, while standard patient training will be provided to patients in the second group.

Severity of urinary symptoms, quality of life and subjective perception of improvement Before BTx-A application, 2 weeks and 12 weeks after BTX-A application, International Incontinence Consultation Questionnaire - Women's Lower Urinary Tract Symptoms (ICIQ-FLUTS), 1-hour ped test, International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS) and Global Perception of Improvement will be evaluated.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • over the age of 18 (those with a Mini Mental Test score of 24 and above for individuals over the age of 65),
  • Who has Non-Neurogenic Overactive Bladder Syndrome,
  • Patients who received Routine Botulinum Toxin-A administration because they did not respond to conservative treatment,
  • Patients who volunteer to participate in the study will be included.

Exclusion criteria

  • Patients with Neurogenic Overactive Bladder Syndrome,
  • Pregnant Women,
  • Lack of cooperation in evaluation and/or treatment and lack of literacy status,
  • Patients with urogynocological/anatomical abnormalities,
  • Patients receiving pelvic radiation therapy,
  • Patients with psychiatric or neurogenic disorders and
  • Patients who have not given consent to the study and do not have an informed consent form (BGOF).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

pelvic physiotherapy
Experimental group
Treatment:
Other: pelvic floor exercise
Other: bladder training
standard patient education
Active Comparator group
Treatment:
Other: Standard Patient Education

Trial contacts and locations

1

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Central trial contact

Ceren Gursen, associate professor

Data sourced from clinicaltrials.gov

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