Clinical trial NCT05719584: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
postmenopausal
females
exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 36
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pelvic organ prolapse quantification (POP-Q)
timeFrame: 12th week
measure: Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
timeFrame: 12th week
measure: Prolapse Quality of life questionnaire(P-QOL)
timeFrame: 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: hina gul, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.