NCT06780657

Brief Summary

Overactive Bladder Syndrome (OAB) is a condition characterized by a sudden and urgent need to urinate, with or without urge incontinence, accompanied by increased urinary frequency. This syndrome significantly impacts individuals' social and economic lives, psychological well-being, work productivity, daily activities, and overall quality of life. The Abdominal Hypopressive Technique (AHT) was suggested by Caufriez for the treatment of pelvic floor disorders in women. It has been utilized in the treatment of pelvic floor dysfunctions, such as Urinary Incontinence (UI), particularly in postpartum women. A review of the existing literature reveals a lack of studies examining the relationship between overactive bladder syndrome and hypopressive exercises. Current research predominantly focuses on the effects of hypopressive exercises on pelvic organ prolapse, pelvic floor muscle tone, urinary incontinence, and stress urinary incontinence. Although AHT was initially developed for the treatment of pelvic floor disorders, it is now recommended for all women, regardless of the presence of UI. However, studies on AHT remain limited, which poses challenges for its broader scientific application. This highlights the need for robust scientific studies to strengthen the evidence base. The present study aims to evaluate the impact of an online hypopressive exercise training program on overactive bladder syndrome symptoms and quality of life. The main questions it aims to answer are:

  • Does online hypopressive exercise training effectively reduce the symptoms of overactive bladder syndrome?
  • Does online hypopressive exercise training effective in improving the quality of life among women with overactive bladder syndrome?

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 17, 2025

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

January 8, 2025

Last Update Submit

January 16, 2025

Conditions

Keywords

Overactive Bladder SyndromeOveractive BladderHypopressive ExerciseQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Overactive Bladder Evaluation Form (OAB-V8)

    It is a scale consisting of 8 questions, each with 6 options on a Likert type scale (Not at all-0, very little-1, a little-2, a lot-3, a lot-4, a lot-5) to question the presence of Overactive Bladder Syndrome. The total score is between 0-40. Accordingly, those with a total score of \>11 are classified as Overactive Bladder Syndrome patients.

    At the end of 8 weeks

Secondary Outcomes (1)

  • Overactive Bladder Quality of Life Scale (OAB-q)

    At the end of 8 weeks

Other Outcomes (1)

  • Personal information form

    Baseline

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group will receive an online hypopressive exercise training program for 8 weeks.

Behavioral: Online hypopressive exercise training program

Control Group

NO INTERVENTION

No special intervention.

Interventions

The hypopressive exercises were based on recommendations from the literature and consultation with an expert in the field. Each session will be held twice a week for 20-25 minutes. Participants will perform each exercise 10 times during these sessions.

Experimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No contraindications to performing hypopressive exercises,
  • Voluntary participation in the study,
  • Being between 18 and 65 years of age,
  • Having access to the internet,
  • Ability to speak and understand Turkish.

You may not qualify if:

  • Individuals with lower back pain,
  • Those with uncontrolled hypertension,
  • Individuals with hiatal hernia,
  • Those with a history of inguinal hernia,
  • Pregnant individuals,
  • Those diagnosed with COPD,
  • Individuals with neuromuscular disorders,
  • Those who have undergone abdominal or pelvic surgery,
  • Prior experience with hypopressive exercises.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Denizli, 20160, Turkey (Türkiye)

Location

Related Publications (6)

  • Resende APM, Bernardes BT, Stupp L, Oliveira E, Castro RA, Girao MJBC, Sartori MGF. Pelvic floor muscle training is better than hypopressive exercises in pelvic organ prolapse treatment: An assessor-blinded randomized controlled trial. Neurourol Urodyn. 2019 Jan;38(1):171-179. doi: 10.1002/nau.23819. Epub 2018 Oct 12.

    PMID: 30311680BACKGROUND
  • Navarro Brazalez B, Sanchez Sanchez B, Prieto Gomez V, De La Villa Polo P, McLean L, Torres Lacomba M. Pelvic floor and abdominal muscle responses during hypopressive exercises in women with pelvic floor dysfunction. Neurourol Urodyn. 2020 Feb;39(2):793-803. doi: 10.1002/nau.24284. Epub 2020 Jan 27.

    PMID: 31985114BACKGROUND
  • Soriano L, Gonzalez-Millan C, Alvarez Saez MM, Curbelo R, Carmona L. Effect of an abdominal hypopressive technique programme on pelvic floor muscle tone and urinary incontinence in women: a randomised crossover trial. Physiotherapy. 2020 Sep;108:37-44. doi: 10.1016/j.physio.2020.02.004. Epub 2020 Feb 19.

    PMID: 32707289BACKGROUND
  • Molina-Torres G, Moreno-Munoz M, Rebullido TR, Castellote-Caballero Y, Bergamin M, Gobbo S, Hita-Contreras F, Cruz-Diaz D. The effects of an 8-week hypopressive exercise training program on urinary incontinence and pelvic floor muscle activation: A randomized controlled trial. Neurourol Urodyn. 2023 Feb;42(2):500-509. doi: 10.1002/nau.25110. Epub 2022 Dec 8.

    PMID: 36482844BACKGROUND
  • Jose-Vaz LA, Andrade CL, Cardoso LC, Bernardes BT, Pereira-Baldon VS, Resende APM. Can abdominal hypropressive technique improve stress urinary incontinence? an assessor-blinded randomized controlled trial. Neurourol Urodyn. 2020 Nov;39(8):2314-2321. doi: 10.1002/nau.24489. Epub 2020 Aug 19.

    PMID: 32813928BACKGROUND
  • Ithamar L, de Moura Filho AG, Benedetti Rodrigues MA, Duque Cortez KC, Machado VG, de Paiva Lima CRO, Moretti E, Lemos A. Abdominal and pelvic floor electromyographic analysis during abdominal hypopressive gymnastics. J Bodyw Mov Ther. 2018 Jan;22(1):159-165. doi: 10.1016/j.jbmt.2017.06.011. Epub 2017 Jun 21.

    PMID: 29332741BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Women who meet the inclusion criteria will be distributed to the experimental and control groups in a randomized controlled manner.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of Health Sciences, Professor

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 17, 2025

Study Start

August 30, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

January 17, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations