Clinical trial NCT06204718: Preventing Pelvic Floor Dysfunction With Pelvic Floor Exercises
Official title: Preventing Pelvic Floor Dysfunction With Standard and Reflexive Pelvic Floor Exercises in Addition to Global Postural Re-education
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prevention Pelvic Muscle Dysfunction
Keywords: Global postural re-education
Reflexive Pelvic Floor Exercises
Prevention pelvic floor dysfunction
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
Collaborators: name: Ebru Kaya Mutlu
First posted: 2024-01-12
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study participants will be randomised into 2 groups. Group 1: 1st assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 3rd assessment 2nd Group: 1st assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 3rd assessment

Detailed description: Voluntary participants who agreed to participate in the study will be randomised into 2 groups of 36 people each (standard pelvic floor exercises and involuntary reflexive pelvic floor exercises) with the "Research Randomizer" programme (https://www.randomizer.org/). Group 1 (36 people) will receive Global Postural Reeducation training plus standard pelvic floor exercises for 12 weeks, 7 days a week (Total 84 sessions, 15 sessions face to face, 69 sessions home programme). Even numbers will be included in the 2nd group (36 people) and involuntary reflexive pelvic floor exercises will be given in addition to Global Postural Reeducation training for 12 weeks, 7 days a week (Total 84 sessions, 15 sessions face-to-face, 69 sessions home programme). In the study, detailed pelvic floor training will be given to both groups and the same assessments will be made on the pelvic floor muscles. After the initial assessments are completed, both groups will be given a total of 42 sessions of standard and involuntary reflexive pelvic floor exercises for 6 weeks (7 days a week). Participants in both groups will be evaluated at the end of 6 weeks and the remaining 6 weeks exercise programme will be given according to the arranged programme. At the end of the 12th week, the participants will be evaluated again.

Group 1: 1st assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 3rd assessment 2nd Group: 1st assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 3rd assessment

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Being a desk worker between the ages of 18-65
* No pelvic floor dysfunction
* Being a woman

Exclusion Criteria:

* Systemic diseases such as hypertension and diabetes mellitus
* Presence of respiratory disease (asthma, COPD, etc...)
* Hormone replacement therapy
* History of neurogenic bladder
* Gynaecological cancer or collagen disease
* Breastfeeding
* Pregnancy
* Early postnatal period (less than one year)
* Pelvic organ prolapse (POP) or gynecological surgery
* Menopause
* Psychiatric comorbidities and/or cognitive impairment
* Impossibility of intra-vaginal physiotherapeutic examination due to untreated active or recurrent urinary infection, haematuria, or vaginal pain during physiotherapy assessment

Primary outcomes:
measure: Pelvic Floor Distress Inventory-PFDI-20
timeFrame: Baseline
measure: Pelvic Floor Distress Inventory-PFDI-20
timeFrame: 6 Weeks Later
measure: Pelvic Floor Distress Inventory-PFDI-20
timeFrame: 12 Weeks Later
measure: The female sexual function index (FSFI)
timeFrame: Baseline
measure: The female sexual function index (FSFI)
timeFrame: 6 Weeks Later
measure: The female sexual function index (FSFI)
timeFrame: 12 Weeks Later
measure: Global Pelvic Floor Bother Questionnaire
timeFrame: Baseline
measure: Global Pelvic Floor Bother Questionnaire
timeFrame: 6 Weeks Later
measure: Global Pelvic Floor Bother Questionnaire
timeFrame: 12 Weeks Later
measure: Overactive Bladder Questionnaire (OAB-V8)
timeFrame: Baseline
measure: Overactive Bladder Questionnaire (OAB-V8)
timeFrame: 6 Weeks Later
measure: Overactive Bladder Questionnaire (OAB-V8)
timeFrame: 12 Weeks Later
measure: Pelvic Muscle Assessment
timeFrame: Baseline
measure: Pelvic Muscle Assessment
timeFrame: 6 Weeks Later
measure: Pelvic Muscle Assessment
timeFrame: 12 Weeks Later
Secondary outcomes:
measure: Waist/ Hip Ratio
timeFrame: Baseline
measure: Waist/ Hip Ratio
timeFrame: 6 Weeks Later
measure: Waist/ Hip Ratio
timeFrame: 12 Weeks Later
measure: Estimating body fat
timeFrame: Baseline
measure: Estimating body fat
timeFrame: 6 Weeks Later
measure: Estimating body fat
timeFrame: 12 Weeks Later
measure: ICIQ-SF: International Consultation on Incontinence Questionnaire-Short Form
timeFrame: Baseline
measure: ICIQ-SF: International Consultation on Incontinence Questionnaire-Short Form
timeFrame: 6 Weeks Later
measure: ICIQ-SF: International Consultation on Incontinence Questionnaire-Short Form
timeFrame: 12 Weeks Later
Other outcomes:
Locations:
city: Bandırma
country: Turkey
facility: Bandırma Onyedi Eylül University
state: Balıkesir
Study officials:
affiliation: Bandırma Onyedi Eylül University
name: Ebru Kaya Mutlu, Professor, PhD
role: STUDY_DIRECTOR
References: