Effects of the Hypopressive Exercises in Women With Pelvic Organ Prolapse

NCT06352112 | Completed

• 1 other identifier: 02.04.2024 - POP
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Floor Disorders; Prolapse; Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Severity of pelvic floor dysfunction

  at baseline and at week 8

Study Arms (2)

Pelvic Floor Muscle Training

EXPERIMENTAL

Participants received pelvic floor muscle training only.

Other: Pelvic Floor Muscle Training

Pelvic Floor Muscle Training combined with Hypopressive Exercises

EXPERIMENTAL

Participants received hypopressive exercise in addition to pelvic floor muscle training.

Other: Pelvic Floor Muscle Training; Other: Hypopressive Exercises

Interventions

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.

Pelvic Floor Muscle Training; Pelvic Floor Muscle Training combined with Hypopressive 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.

Pelvic Floor Muscle Training combined with Hypopressive Exercises

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Only women with POP were included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead
• Istanbul Training and Research Hospital: collaborator

Study Sites (1)

Istanbul Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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: 10.1002/nau.21149. Epub 2011 Oct 28.

  PMID: 22038880 RESULT

• 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;130(1):5-9. doi: 10.1590/s1516-31802012000100002.

  PMID: 22344353 RESULT

• 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. 2019 Jan;38(1):171-179. doi: 10.1002/nau.23819. Epub 2018 Oct 12.

  PMID: 30311680 RESULT

• 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/s00192-022-05407-y. Epub 2022 Nov 23.

  PMID: 36418569 RESULT

• 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 randomized controlled trial. Neurourol Urodyn. 2023 Feb;42(2):500-509. doi: 10.1002/nau.25110. Epub 2022 Dec 8.

  PMID: 36482844 RESULT

MeSH Terms

Conditions

Pelvic Floor Disorders; Prolapse

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Türkan Akbayrak, Prof. Dr.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: March 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: February 15, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)