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

NCT06209333 | Unknown

• 1 other identifier: KA-23003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overactive Bladder Syndrome (OABS)

Keywords

pelvic floor exercise; bladder training; standard patient education; botulinum toxin-A; BTx-A

Outcome Measures

Primary Outcomes (2)

• International Incontinence Consultation Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)

  Storage symptoms are scored as 0-16 points, urination symptoms are scored as 0-12, incontinence symptoms are scored as 0-20 points. The effect of the patient's symptoms on their daily activities has 5 options, including "0-Never", "4-Always".The highest possible score is 48. A higher score means a worse outcome.

  the change in the symptoms of the lower urinary tract from the beginning to the end of 12 weeks and the effects of symptoms on quality of life

• International Incontinence Consultation Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)

  This scale aims to evaluate male lower urinary tract symptoms in the last 4 weeks and the effects of symptoms on quality of life with 13 questions. The effect of the patient's symptoms on their daily activities has 5 options, including "0-Never", "4-Always".The highest possible score is 52. A higher score means a worse outcome.

  the change in the symptoms of the lower urinary tract from the beginning to the end of 12 weeks and the effects of symptoms on quality of life

Secondary Outcomes (7)

• International Incontinence Consultation Bladder Diary (ICIQ-Bladder Diary):

  change in the severity of urinary incontinence from the beginning to the end of 12 weeks

• 1-Hour Ped Test

  change in the severity of urinary incontinence from the beginning to the end of 12 weeks

• International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS):

  Change in quality of life from baseline at 12 weeks

• Global Perception of Improvement Scale

  Change from baseline patient global change at 12 weeks

• Compliance with Standard Patient Education

  compliance with Standard Patient Education at the end of 12 weeks

Study Arms (2)

pelvic physiotherapy

EXPERIMENTAL

Other: bladder training; Other: pelvic floor exercise

standard patient education

ACTIVE COMPARATOR

Other: Standard Patient Education

Interventions

Standard Patient Education OTHER

Standard Patient Education will take approximately 20 minutes. Within the scope of standard patient education, some recommendations will be made to the patient to lose weight, drink sufficient water, avoid consuming caffeinated foods and beverages, acidic/carbonated or alcoholic beverages, spicy/acidic foods, and quit smoking. Patients will be evaluated on the day they receive standard patient training (before receiving this training) and 10 weeks after the training.

standard patient education

bladder training OTHER

Interval urination in bladder training in bladder training will be determined according to the bladder diaries filled in by the patients. If the patient is able to do it, bladder education will be improved by increasing the interval urination in bladder training. A total of 5 sessions of bladder training will be applied to patients, the first session of which will be face-to-face. Within the scope of Bladder Training, the patient will be given information about bladder, pelvic floor, incontinence and relaxation techniques. The patient will be asked to fill out a 3-day bladder diary before starting bladder training, and an appropriate progressive timed voiding program will be drawn according to the bladder diaries, and the patient will be given a training brochure to implement this program.

pelvic physiotherapy

pelvic floor exercise OTHER

This training will take between 45 and 60 minutes.Within the scope of exercise training, patients will be taught 3 types of contractions: maximal (fast), slow and submaximal contractions. The patient will be asked to continue the maximum and submaximal contraction for 1-2 seconds, and to continue the Deceleration contraction for 3-10 seconds. These contractions will be performed in different positions such as supine, lying on the side, sitting, crawling, squatting and standing, specifically for the pelvic floor November muscle strength of the patient. These exercises will be performed every day and each type of contraction (maximal, slow and submaximal contraction) will be performed 8-12 repetitions, 3 sets per day. Progress will be achieved with follow-ups.

pelvic physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Aslı Aslan

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• The Overactive Bladder: From Basic Science to Clinical Management Consensus Conference. Proceedings. London, England, June 29, 1997. Urology. 1997 Dec;50(6A Suppl):1-114. No abstract available.

  PMID: 9446279 BACKGROUND

• Orasanu B, Mahajan ST. The use of botulinum toxin for the treatment of overactive bladder syndrome. Indian J Urol. 2013 Jan;29(1):2-11. doi: 10.4103/0970-1591.109975.

  PMID: 23671356 BACKGROUND

• Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.

  PMID: 12559262 BACKGROUND

• Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.

  PMID: 12794644 BACKGROUND

• Mertoglu O, Ucer O, Ceylan Y, Bozkurt O, Gunlusoy B, Albaz AC, Demir O; Aegean Study Group of Society of Urological Surgery. Reliability and Validity of the Turkish Language Version of the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms. Int Neurourol J. 2016 Jun;20(2):159-63. doi: 10.5213/inj.1630460.230. Epub 2016 Jun 24.

  PMID: 27377949 BACKGROUND

• Shen L, Hou L, Li B, Jin X, Han F, Wang Y. Translation of the ICIQ-bladder diary and its validation among Chinese females with lower urinary tract symptoms. Int Urogynecol J. 2020 Dec;31(12):2535-2542. doi: 10.1007/s00192-020-04339-9. Epub 2020 May 28.

  PMID: 32468173 BACKGROUND

• Castellani D, Saldutto P, Galica V, Pace G, Biferi D, Paradiso Galatioto G, Vicentini C. Low-Dose Intravaginal Estriol and Pelvic Floor Rehabilitation in Post-Menopausal Stress Urinary Incontinence. Urol Int. 2015;95(4):417-21. doi: 10.1159/000381989. Epub 2015 May 30.

  PMID: 26043913 BACKGROUND

• Ptak M, Ciecwiez S, Brodowska A, Starczewski A, Nawrocka-Rutkowska J, Diaz-Mohedo E, Rotter I. The Effect of Pelvic Floor Muscles Exercise on Quality of Life in Women with Stress Urinary Incontinence and Its Relationship with Vaginal Deliveries: A Randomized Trial. Biomed Res Int. 2019 Jan 6;2019:5321864. doi: 10.1155/2019/5321864. eCollection 2019.

  PMID: 30723739 BACKGROUND

Central Study Contacts

Ceren Gursen, associate professor

CONTACT

+905380644120; cerengursen@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: January 17, 2024
• Study Start: October 15, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)