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NCT Number: NCT07440875

Effects of Pelvic Floor Muscle Training With & Without Hypopressive Exercises

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.

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Key information

Conditions

Pelvic Organ Prolapse Behavior Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Motor Activity Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Qasim Sandhu Hospital

Lahore, Punjab Province, 6400, Pakistan

Location status: Recruiting

Location contact

mehar un nisa UN NISA, MS

CONTACT

[email protected]

03344563221

saweba irfan, MSPT-WH

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypopressive excercises

Other

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 each exercise repeated three times per session.

No voluntary contraction of pelvic floor or abdominal muscles was permitted during performance.

pelvic training excercises

Other

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 30-35 minutes to enhance dynamic postural stability.

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS) for assessment of pain

    Time frame: 4 week

    the test-retest reliability for the NPRS has been demonstrated to be moderate to high, varying from 0.67 to 0.96. Criterion validity has not been established for the NPRS as there are no 'gold standards' for pain measurement; however, when correlated with the VAS, the NPRS is determined to have 0.79 to 0.95 convergent validity.

  2. Modified Oxford Scale for assessment of muscle strength

    Time frame: 4 weeks

    The modified Oxford scale is a practical tool for use in clinical studies and can provide an adequate measure of PFM strength, provided a study is sufficiently powered. The Icc value r=0.97 and Cronbach @ is 0.845. The scale demonstrates high intra-rater reliability, meaning that the same clinician tends to produce consistent results when re-assessing the same patient

  3. PFIQ7 for assessment of quality of life

    Time frame: 4 weeks

    Pelvic Floor Impact Questionnaire-7 is valid, reliable, and responsive short forms of condition-specific quality-of-life questionnaires for women with pelvic floor disorders.Construct validity of the tool demonstrated by many fold higher scores among patients with POP compared with women without POP (p<0.0001)

Study contacts

Contact information is provided by the study sponsor or research team.

imran amjad, PhD

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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