Pelvic Floor Muscle Training and Hypopressive Exercises for Pelvic Organ Prolapse

NCT01196598 | Unknown

• 1 other identifier: 1978/07
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

To verify if pelvic floor muscle training program and/or a hypopressive exercise program could improve women with stage II of pelvic organ prolapse, their symptoms or pelvic floor muscle strength.

Conditions

Pelvic Organ Prolapse

Keywords

pelvic floor; pelvic organ prolapse

Outcome Measures

Primary Outcomes (1)

• Pelvic floor muscle changes

  Digital palpation - Evaluates the pelvic floor muscle contraction and assign values according to scales: Oxford (previously validated) and muscular endurance (measured in seconds) Surface electromyography - evaluates the electrical activity generated by activation of motor units of pelvic floor muscles - during the rest and during the maximum voluntary contraction 2D perineal ultrasound - evaluates the cross sectional area of levator ani muscle.

  3 months after the begining of treatment

Secondary Outcomes (1)

• Pelvic Organ Prolapse changes

  3 months after the begining of treatment

Study Arms (4)

PFMT group

ACTIVE COMPARATOR

Women who undergo to three months of a pelvic floor muscle training program.

Other: Exercises

HE + PFM group

ACTIVE COMPARATOR

Women who undergo to three months of a hypopressive exercises plus pelvic floor muscle contraction program.

Other: Exercises

HE group

ACTIVE COMPARATOR

Women who undergo to three months of a hypopressive exercises program.

Other: Exercises

Control

ACTIVE COMPARATOR

Women who undergo to a session for lifestyle advice.

Other: Exercises

Interventions

Exercises OTHER

Three individual initial sessions for learn about pelvic floor muscle localization and function; receive lifestyle advice and practice the exercises correctly. The control group receive only lifestyle advice. Followed by three months of home training with appointments each two weeks with physiotherapist.

Control; HE + PFM group; HE group; PFMT group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women with stage II of pelvic organ prolapse, preferably symptomatic and not to be submitted to surgery to correct pelvic organ prolapse during the study

You may not qualify if:

• Neuromuscular diseases and use of hormonal therapy

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Exercise

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ana Paula M. Resende

  Post graduate student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 8, 2010
• Study Start: January 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2011
• Last Updated: September 8, 2010

Record last verified: 2010-08

Locations

BR (1)