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Completed

NCT Number: NCT05719584

Pelvic Floor Muscle Training With and Without Hypopressive Exercises in Postmenopausal Females.

To compare the effects of pelvic floor muscle training with and without hypopressive exercises on pelvic organ prolapse in postmenopausal females

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Key information

Conditions

Pelvic Organ Prolapse Behavior Motor Activity Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jinnah hospital

Lahore, Punjab Province, 64000, Pakistan

About this study

In this randomized controlled trial multigravida, postmenopausal females with stage 1 and 2 pelvic organ prolapse will be taken (exclusion criteria includes cesarean section females, ovarian cysts ,UTIs and neoplasm). This study will be conducted in Jinnah hospital , Lahore. Sample size of 36 will be taken according to inclusion criteria. Study will be completed in 10 months after approval of synopsis. Non-Probability convenient sampling will be used. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lottery method, to either the Pelvic floor muscle training group or group with combined pelvic floor muscle exercise and hypopressive exercise. Treatment period will be 12 weeks 3 days per week. The participants will be advised not to use other forms of treatment during the trial (pharmacologic or non pharmacologic treatment). All subjects will be assessed before and after treatment by POP-Q, pelvic floor impact questionnaire and P-QOL. Data will be analyzed by using SPSS 25 statistical software.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Multigravida
  • Previous spontaneous vaginal deliveries
  • Diagnosed Stage 1 and 2 pelvic organ prolapse
  • Post-menopausal females

Exclusion criteria

  • History of cesarean section
  • History of ovarian cysts
  • History of UTIs
  • History of neoplasm
  • Instrumental deliveries

Treatment and study plan

Hypopressive exercises

Other

patients will receive pelvic floor muscle training with hypopressive exercises at outpatient department. Treatment will continue for 12 weeks 3 days per week. They will receive information about the localization and function of the PFM and transversus abdominis (TrA) muscles. Next, lying in a supine position with flexed knees and hips, they will localize their own pelvic floor with the help of touching their perineum. Then they will be instructed how to contract the PFM correctly, then they will directed to contract PFMs and in the end participants will be taught how to voluntarily contract the PFM simultaneously with diaphragmatic Aspiration(8-10 repetitions daily

Pelvic Floor Muscle training

Other

patients will receive only pelvic floor muscle training exercises(pelvic floor muscle contractions) at the outpatient department and treatment will continue for 12 weeks 3 days per week. PFMT will be performed in the lying, sitting and standing positions. The patients will be instructed to perform three sets of 8-12 maximum voluntary contractions held for 6 sec, with 12 sec of rest between each contraction, followed by three fast contractions in a row

Primary outcomes

  1. pelvic organ prolapse quantification (POP-Q)

    Time frame: 12th week

    POP-Q can be seen in Many clinical settings & published researches and it is used to grade and measure of pelvic organ prolapse during its assessment.

  2. Pelvic Floor Impact Questionnaire-7 (PFIQ-7)

    Time frame: 12th week

    It is a short and less comprehensive version of Pelvic Floor Impact Questionnaire (PFIQ). It is a health related questionnaire for women with pelvic floor conditions.

    consists of 7 questions that need to be answered 3 times each.

  3. Prolapse Quality of life questionnaire(P-QOL)

    Time frame: 12th week

    A simple, valid, reliable questionnaire to assess the severity of symptoms and their impact on the quality of life in women with Pelvic organ prolapse. There are several questions which a participant needs to answer.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Pelvic Floor Muscle Training With and Without Hypopressive Exercises on Pelvic Organ Prolapse in Postmenopausal Females.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2023
Registry last updated
Dec 27, 2024

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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