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

NCT ID: NCT05719584

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-08-01

Brief Summary

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

Detailed Description

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In this randomized controlled trial multigravida, postmenopausal females with stage 1 and 2 pelvic organ prolapse will be taken (exclusion criteria includes cesarean section females, ovarian cysts ,UTIs and neoplasm). This study will be conducted in Jinnah hospital , Lahore. Sample size of 36 will be taken according to inclusion criteria. Study will be completed in 10 months after approval of synopsis. Non-Probability convenient sampling will be used. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lottery method, to either the Pelvic floor muscle training group or group with combined pelvic floor muscle exercise and hypopressive exercise. Treatment period will be 12 weeks 3 days per week. The participants will be advised not to use other forms of treatment during the trial (pharmacologic or non pharmacologic treatment). All subjects will be assessed before and after treatment by POP-Q, pelvic floor impact questionnaire and P-QOL. Data will be analyzed by using SPSS 25 statistical software.

Conditions

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Pelvic Organ Prolapse

Keywords

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pelvic organ prolapse postmenopausal females exercises

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hypopressive exercises

pelvic floor muscle exercises along with hypopressive exercises

Group Type EXPERIMENTAL

hypopressive exercises

Intervention Type 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

pelvic floor muscle training

Intervention Type 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

pelvic floor muscle training

pelvic floor muscle exercises alone

Group Type ACTIVE_COMPARATOR

pelvic floor muscle training

Intervention Type 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

Interventions

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hypopressive exercises

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

Intervention Type OTHER

pelvic floor muscle training

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* History of cesarean section
* History of ovarian cysts
* History of UTIs
* History of neoplasm
* Instrumental deliveries
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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hina gul, MS-OMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Jinnah hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 33918633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25862491 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 27439423 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 30311680 (View on PubMed)

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).

Reference Type BACKGROUND

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

Reference Type BACKGROUND
PMID: 32627701 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32316686 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31985114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31297874 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/36482844/

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.

Other Identifiers

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REC/RCR & AHS/23/0502

Identifier Type: -

Identifier Source: org_study_id