Pelvic Floor Muscle Training With and Without Hypopressive Exercises in Postmenopausal Females.
Primary Purpose
Pelvic Organ Prolapse
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
hypopressive exercises
pelvic floor muscle training
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse, postmenopausal, females, exercises
Eligibility Criteria
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
Sites / Locations
- Jinnah hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hypopressive exercises
pelvic floor muscle training
Arm Description
pelvic floor muscle exercises along with hypopressive exercises
pelvic floor muscle exercises alone
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05719584
First Posted
January 31, 2023
Last Updated
July 31, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05719584
Brief Title
Pelvic Floor Muscle Training With and Without Hypopressive Exercises in Postmenopausal Females.
Official Title
Effects of Pelvic Floor Muscle Training With and Without Hypopressive Exercises on Pelvic Organ Prolapse in Postmenopausal Females.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the effects of pelvic floor muscle training with and without hypopressive exercises on pelvic organ prolapse in postmenopausal females
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
pelvic organ prolapse, postmenopausal, females, exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hypopressive exercises
Arm Type
Experimental
Arm Description
pelvic floor muscle exercises along with hypopressive exercises
Arm Title
pelvic floor muscle training
Arm Type
Active Comparator
Arm Description
pelvic floor muscle exercises alone
Intervention Type
Other
Intervention Name(s)
hypopressive exercises
Intervention Description
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
Intervention Name(s)
pelvic floor muscle training
Intervention Description
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
Primary Outcome Measure Information:
Title
pelvic organ prolapse quantification (POP-Q)
Description
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.
Time Frame
12th week
Title
Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
Description
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.
Time Frame
12th week
Title
Prolapse Quality of life questionnaire(P-QOL)
Description
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.
Time Frame
12th week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
postmenopausal females
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
imran amjad, PhD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hina gul, MS-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
64000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hina gul, t-DPT
Phone
03214979172
Email
hina.gul@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
rabia iqbal, MSWHPT
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25862491
Citation
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.
Results Reference
background
PubMed Identifier
27439423
Citation
Barber MD. Pelvic organ prolapse. BMJ. 2016 Jul 20;354:i3853. doi: 10.1136/bmj.i3853. No abstract available.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
30311680
Citation
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.
Results Reference
background
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).
Results Reference
background
PubMed Identifier
32627701
Citation
Fleischer K, Thiagamoorthy G. Pelvic organ prolapse management. Post Reprod Health. 2020 Jun;26(2):79-85. doi: 10.1177/2053369120937594.
Results Reference
background
PubMed Identifier
32316686
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.
Results Reference
background
PubMed Identifier
31985114
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.
Results Reference
background
PubMed Identifier
31297874
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.
Results Reference
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Pelvic Floor Muscle Training With and Without Hypopressive Exercises in Postmenopausal Females.
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