Effects of the Hypopressive Exercises in Women With Pelvic Organ Prolapse

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06352112
• Other study ID #: 02.04.2024 - POP
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: April 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Floor Disorders
• Pelvic Organ Prolapse
• Prolapse
• Prolapse; Female

Intervention

Other:
• Pelvic Floor Muscle Training
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
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.

Locations

Country	Name	City	State
Turkey	Istanbul Research and Training Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Bernardes BT, Resende AP, Stupp L, Oliveira E, Castro RA, Bella ZI, Girao MJ, Sartori MG. Efficacy of pelvic floor muscle training and hypopressive exercises for treating pelvic organ prolapse in women: randomized controlled trial. Sao Paulo Med J. 2012;1 — View Citation

Bo K, Angles-Acedo S, Batra A, Braekken IH, Chan YL, Jorge CH, Kruger J, Yadav M, Dumoulin C. Are hypopressive and other exercise programs effective for the treatment of pelvic organ prolapse? Int Urogynecol J. 2023 Jan;34(1):43-52. doi: 10.1007/s00192-02 — View Citation

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 random — View Citation

Resende AP, Stupp L, Bernardes BT, Oliveira E, Castro RA, Girao MJ, Sartori MG. Can hypopressive exercises provide additional benefits to pelvic floor muscle training in women with pelvic organ prolapse? Neurourol Urodyn. 2012 Jan;31(1):121-5. doi: 10.100 — View Citation

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic Floor Muscle Activation	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.	at baseline and at week 8
Secondary	Severity of pelvic floor dysfunction	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	at baseline and at week 8