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

NCT05719584 | Completed

• 1 other identifier: REC/RCR & AHS/23/0502
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse; postmenopausal; females; exercises

Outcome Measures

Primary Outcomes (3)

• pelvic organ prolapse quantification (POP-Q)

  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.

  12th week

• Pelvic Floor Impact Questionnaire-7 (PFIQ-7)

  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.

  12th week

• Prolapse Quality of life questionnaire(P-QOL)

  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.

  12th week

Study Arms (2)

hypopressive exercises

EXPERIMENTAL

pelvic floor muscle exercises along with hypopressive exercises

Other: hypopressive exercises; Other: pelvic floor muscle training

pelvic floor muscle training

ACTIVE COMPARATOR

pelvic floor muscle exercises alone

Other: pelvic floor muscle training

Interventions

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

hypopressive exercises

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

hypopressive exercises; pelvic floor muscle training

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: postmenopausal females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Jinnah hospital

Lahore, Punjab Province, 64000, Pakistan

Location

Related Publications (10)

• Nam G, Lee SR, Choi S. Clitoromegaly, Vulvovaginal Hemangioma Mimicking Pelvic Organ Prolapse, and Heavy Menstrual Bleeding: Gynecologic Manifestations of Klippel-Trenaunay Syndrome. Medicina (Kaunas). 2021 Apr 9;57(4):366. doi: 10.3390/medicina57040366.

  PMID: 33918633 BACKGROUND

• Alves FK, Riccetto C, Adami DB, Marques J, Pereira LC, Palma P, Botelho S. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas. 2015 Jun;81(2):300-5. doi: 10.1016/j.maturitas.2015.03.006. Epub 2015 Mar 14.

  PMID: 25862491 BACKGROUND

• Barber MD. Pelvic organ prolapse. BMJ. 2016 Jul 20;354:i3853. doi: 10.1136/bmj.i3853. No abstract available.

  PMID: 27439423 BACKGROUND

• Fatima Q, Razzaqe H, Kashif M, Aslam F. Association of parity and pelvic organ prolapse. Journal of Rawalpindi Medical College Students Supplement. 2016;20:104-8.

  BACKGROUND

• 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 BACKGROUND

• Parle J, Shahmalak S, Irkar D. Effect of Hypopressive exercise in women with Pelvic Organ Prolapse. Nepal Journal of Obstetrics and Gynaecology. 2021;16(1).

  BACKGROUND

• Fleischer K, Thiagamoorthy G. Pelvic organ prolapse management. Post Reprod Health. 2020 Jun;26(2):79-85. doi: 10.1177/2053369120937594.

  PMID: 32627701 BACKGROUND

• Navarro-Brazalez B, Prieto-Gomez V, Prieto-Merino D, Sanchez-Sanchez B, McLean L, Torres-Lacomba M. Effectiveness of Hypopressive Exercises in Women with Pelvic Floor Dysfunction: A Randomised Controlled Trial. J Clin Med. 2020 Apr 17;9(4):1149. doi: 10.3390/jcm9041149.

  PMID: 32316686 BACKGROUND

• Navarro Brazalez B, Sanchez Sanchez B, Prieto Gomez V, De La Villa Polo P, McLean L, Torres Lacomba M. Pelvic floor and abdominal muscle responses during hypopressive exercises in women with pelvic floor dysfunction. Neurourol Urodyn. 2020 Feb;39(2):793-803. doi: 10.1002/nau.24284. Epub 2020 Jan 27.

  PMID: 31985114 BACKGROUND

• Juez L, Nunez-Cordoba JM, Couso N, Auba M, Alcazar JL, Minguez JA. Hypopressive technique versus pelvic floor muscle training for postpartum pelvic floor rehabilitation: A prospective cohort study. Neurourol Urodyn. 2019 Sep;38(7):1924-1931. doi: 10.1002/nau.24094. Epub 2019 Jul 11.

  PMID: 31297874 BACKGROUND

Related Links

• A study conducted in 2023 by Guadalupe Molina-Torres et al, was to assess the effects of an 8-week, highly supervised programme of hypopressive exercises on the strength of the pelvic floor muscles and the signs and symptoms of urinary incontinence.

MeSH Terms

Conditions

Pelvic Organ Prolapse; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• hina gul, MS-OMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: September 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)