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

Pelvic Organ Prolapse Clinical Trial

Official title:

Effects of Pelvic Floor Muscle Training With and Without Hypopressive Exercises on Pelvic Organ Prolapse in Postmenopausal Females.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05719584
• Other study ID #: REC/RCR & AHS/23/0502
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
Pakistan	Jinnah hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

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. — View Citation

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

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.

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

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. — View Citation

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. — View Citation

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. — View Citation

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).

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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