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Completed

NCT Number: NCT06352112

Effects of the Hypopressive Exercises in Women With Pelvic Organ Prolapse

The aim of this study was compare home-based pelvic floor muscle training (PFMT) alone and home-based PFMT combined with hypopressive exercise (HE) in terms of pelvic floor muscle (PFM) activation and severity of pelvic floor dysfunction (PFD) in women with pelvic organ prolapse (POP) for eight weeks. For this purpose, the participants were randomly divided into two groups: [PFMT alone (n:15) and PFMT combined with HE(n:17)]. DuoBravo EMG device for evaluation of PFM activation and "Pelvic Floor Distress Inventory-20" was used to evaluate the severity of PFD. All evaluations were performed twice in total, at baseline and at week 8.

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pregnancy Complications Prolapse Prolapse; Female Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Research and Training Hospital

Istanbul, Turkey (Türkiye)

About this study

Pelvic floor muscle training (PFMT), which provides increased structural support of the pelvic organs by improving the functional strength, endurance and coordination of the pelvic floor muscles (PFM), has been a grade A recommendation based on Level 1 evidence to improve symptoms and stages of pelvic organ prolapse (POP). On the other hand, hypopressive exercises (HE) are a group of exercises that, when applied, relax the diaphragm, activate the abdominal muscles, activate the transversus abdominis muscle by reducing intra-abdominal pressure, thus providing reflex activation in the PFM, and are known to improve urinary incontinence and POP with these features. Although there are studies investigating the effects of both exercise groups on POP, the results of the studies are contradictory and more research is needed on this subject.For this reason, in this study, the investigators aimed to compare home-based PFMT alone and home-based PFMT combined with HE in terms of PFM activation and severity of pelvic floor dysfunction in women with POP for eight weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • having been diagnosed with POP according to Pelvic Organ Prolapse Quantification System by a gynecologist;
  • being literate
  • being between 20-50 years

Exclusion criteria

  • pregnancy;
  • having a cooperation problems;
  • history of active cancer;
  • finding an urinary infection during evaluation;
  • being in the menstrual period during the evaluation;
  • neurological, orthopedic or serious medical conditions that may affect the patient's pelvic floor functions.

Treatment and study plan

Pelvic Floor Muscle training

Other

PFMT consisted of both slow voluntary contractions lasting 15 seconds each (5-s contraction, 5-s hold and 5-s relaxation) and fast voluntary contractions lasting 2-s each. A set of exercises included 10 slow and 10 fast voluntary contractions. During the first week, women performed five sets of exercises a day, and the exercises were continued for eight weeks by increasing five sets each week. The exercises were performed as home exercises.

Hypopressive exercises

Other

HE program in which different placements of the upper and lower extremities were used in standing, sitting and supine positions, and the participants were asked to perform the exercises with a "hypopressive maneuver" to maintain apnea and rib cage expansion for approximately 10 seconds. Exercises were started with three repetitions a day, and then the number of repetitions was increased to five and/or 10, depending on the participant's tolerance. The exercises were performed as home exercises.

Primary outcomes

  1. Pelvic Floor Muscle Activation

    Time frame: at baseline and at week 8

    It was performed with the DuoBravo EMG device. Patients were asked to squeeze the PFM strongly for 5-s and at the end of the contraction, to relax completely by not pushing the perineum downwards for 5-s. This cycle was repeated five times in total, and the muscle activation responses at the end of the measurement were recorded in µV.

Secondary outcomes

  1. Severity of pelvic floor dysfunction

    Time frame: at baseline and at week 8

    It was performed with the "Pelvic Floor Distress inventory-20 (PFDI-20). The total score of the scale is between 0-300 and the higher the score obtained as a result of the survey, the greater the severity of pelvic floor dysfunction

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Istanbul Training and Research Hospital

Registry information

Official study title

Short-term Effects of the Home-Based Hypopressive Exercises in Women With Pelvic Organ Prolapse: A Retrospective Comparative Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Apr 10, 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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