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Recruiting NCT07440875

Effects of Pelvic Floor Muscle Training With & Without Hypopressive Exercises

No phase Interventional Pelvic Organ Prolapse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hypopressive excercises, pelvic training excercises.
Who it may be relevant to
Registry conditions: Pelvic Organ Prolapse. Basic parameters: 45 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Pelvic Floor Muscle Training With & Without Hypopressive Exercises On Strength, Dyspareunia and Quality Of Life in Pelvic Organ Prolapse

Overview

Pelvic Organ Prolapse (POP) is a prevalent condition affecting women's quality of life due to the descent of pelvic organs caused by weak pelvic floor muscles (PFMs). This randomized controlled trial aims to compare the effects of pelvic floor muscle training (PFMT) alone and PFMT combined with hypopressive exercises in improving pelvic floor muscle strength, reducing dyspareunia, and enhancing overall quality of life in women aged 45-65 diagnosed with stage I-II POP.This study will be randomized controlled trial and will be conducted in Qasim Sandhu Hospital, Muhammadi Medical Trust and Clinic 1. This will undergo 4 sessions totaling 1 month of treatment. . Non-probability convenience sampling technique will be used and 46 participants will be recruited in study after randomization.The subjects will be divided into two groups. Group A will receive pelvic floor muscle training with hypopressive exercises and Group B will receive pelvic floor muscle training without hypopressive exercises receiving baseline treatment.

Detailed description

he study will utilize tools such as the Oxford Grading Scale for muscle strength, the Numeric Pain Rating Scale (VAS) for pain, and the Pelvic Floor Impact Questionnaire (PFIQ-7) for quality of life assessment.Data will be analyzed by using Statistical Package for Social Science SPSS version 25 software to get results of treatment strategies. Statistical significance will be set at P = 0.05.Use of statistical tests will be decided after normality tests.In parametric, independence t-test and paired t-test will be used. In non-parametric, Man-Whitney test will be used.

The purpose of this study is to provide effective data on whether the combination of PFMT and hypopressive exercises offers improvements in pelvic floor strength, dyspareunia, and enhances the quality of life compared to PFMT alone.

Key Words Female,Pelvic Floor, Quality of Life, Dyspareunia, Exercise, Therapy Pelvic Organ Prolapse

Interventions

  • Other hypopressive excercises
    The initial maneuver involved sustaining apnea with rib-cage expansion for approximately 10 seconds in supine, standing, and sitting positions. Participants progressed through hypopressive postures including standing, kneeling, four-point kneeling, sitting, and supine, with varied limb positions. Each hypopressive exercise consisted of 3 repetitions per posture, with a rest breath between repetitions. Sessions included 5-10 hypopressive exercises based on participant skill and readiness, with
  • Other pelvic training excercises
    Week 1: Foundational breathing and supine hypopressive exercises performed 3×/week for 15-20 minutes to establish basic apnea control and postural awareness. Week 2: Progression to seated and standing poses 4×/week for 20-25 minutes, increasing hold time and postural endurance. Week 3: Advanced kneeling and squat-based hypopressive activation 4-5×/week for 25-30 minutes to integrate functional core control. Week 4: Mastery phase with full squat, walking, and combination poses 5×/week for 30-3

Primary outcome measures

  • Numeric Pain Rating Scale (NPRS) for assessment of pain [Time frame: 4 week]
  • Modified Oxford Scale for assessment of muscle strength [Time frame: 4 weeks]
  • PFIQ7 for assessment of quality of life [Time frame: 4 weeks]

Eligibility criteria

Inclusion criteria

  • Married women
  • Age 45-65 years
  • Post menopausal
  • uterine prolapse
  • Stage I \& II

Exclusion criteria

  • Pregnancy or Postpartum (within last 6 months)
  • History of Pelvic floor surgery e.g.hysterectomy
  • Pts with other comorbidities e.g. neuromuscluar disease
  • Participating in other pelvic floor muscle program.e.g. pilates , yoga, Psychiatric disorders effecting compliance.e.g. schizopherenia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Qasim Sandhu Hospital — Lahore

Publications

  • Feigenbaum T. Physical Therapy in the Treatment and Prevention of Pelvic Floor Dysfunctions in Women. The Science Journal of the Lander College of Arts and Sciences. 2022;16(1)
  • Boraschi Gomes V, Fernandes Torres T, Merino D, Castiglione M, Pavione Rodrigues Pereira R, Tanaka C. (PM-05) EFFICACY OF PELVIC FLOOR MUSCLE TRAINING AND PERINEAL MASSAGE IN THE TREATMENT OF WOMEN WITH DYSPAREUNIA: NARRATIVE REVIEW OF THE LITERATURE. The Journal of Sexual Medicine. 2024;21
  • Wang T, Wen Z, Li M. The effect of pelvic floor muscle training for women with pelvic organ prolapse: a meta-analysis. Int Urogynecol J. 2022 Jul;33(7):1789-1801. doi: 10.1007/s00192-022-05139-z. Epub 2022 Mar 21. PMID 35312800
  • Guan Y, Han J. Quality-of-life improvements in patients after various surgical treatments for pelvic organ prolapse. Arch Gynecol Obstet. 2024 Mar;309(3):813-820. doi: 10.1007/s00404-023-07140-3. Epub 2023 Jul 19. PMID 37464172

Identifiers

NCT: NCT07440875 · REC/RCR&AHS/24/0541

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗