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

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05719584

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Other: hypopressive exercises Other: pelvic floor muscle training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hypopressive exercises pelvic floor muscle exercises along with hypopressive exercises	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 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
Active Comparator: pelvic floor muscle training pelvic floor muscle exercises alone	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

Arm

Intervention/Treatment

Experimental: hypopressive exercises

pelvic floor muscle exercises along with hypopressive exercises

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

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

Active Comparator: pelvic floor muscle training

pelvic floor muscle exercises alone

Other: pelvic floor muscle training

Outcome Measures

Primary Outcome Measures

pelvic organ prolapse quantification (POP-Q) [12th week]
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) [12th week]
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) [12th week]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jinnah hospital	Lahore	Punjab	Pakistan	64000

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: hina gul, MS-OMPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05719584

Other Study ID Numbers:

REC/RCR & AHS/23/0502

First Posted:

Feb 9, 2023

Last Update Posted:

Feb 9, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

pelvic organ prolapse

postmenopausal

females

exercises

Additional relevant MeSH terms:

Prolapse

Pelvic Organ Prolapse

Study Results

No Results Posted as of Feb 9, 2023