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

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Other: hypopressive exercises; Other: pelvic floor muscle training

• Registration Number: NCT05719584
• Lead Sponsor: Riphah International University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-09
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hypopressive exercises	hypopressive exercises	pelvic floor muscle exercises along with hypopressive exercises
hypopressive exercises	pelvic floor muscle training	pelvic floor muscle exercises along with hypopressive exercises
pelvic floor muscle training	pelvic floor muscle training	pelvic floor muscle exercises alone

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Jinnah hospital; 🇵🇰 Lahore, Punjab, Pakistan