Clinical trial NCT05253898: Comparison of Pelvic Floor Therapy and Yoga on Stres Urinary Incontinence Incontinence
Official title: Comparison of Group-based Pelvic Floor Physical Therapy and Therapeutic Yoga for Postnatal Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Urinary Tract Disorders
Keywords: Urinary incontinence
Postnatal
Yoga
Pelvic floor muscle
Rehabilitation
Quality of life
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effectiveness of pelvic floor physical therapy (PFT) and therapeutic yoga training (TYT) for women who have postnatal stress urinary incontinence (SUI).

Detailed description: 32 subjects with postnatal stress urinary incontinence will be included in the study after a voluntary consent form will be filled out. Subjects will randomly be divided into two groups according to the order.

Pelvic floor physical therapy (PFT) (n=16) will be Group 1, and therapeutic yoga training (TYT) (n=16) will be the Group 2.

PFT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, pelvic floor muscle contractions in different positions, and abdominal breathing techniques. Each session is planned for 45 minutes.

TYT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, different asanas, and yogi breathing exercises. each session is planned for 45 minutes.

Eligibility criteria: Inclusion Criteria:

* Women ages between 18 and 50 years old,
* Women who have SUI 45 days and above after giving birth
* Patients who accept to join the group sessions and will participate regularly in the treatment program

Exclusion Criteria:

* Women who have pelvic organ prolapsus and fecal incontinence
* Women who have undergone surgery for the lower urinary system
* Those who receive medication treatment for incontinence in the last 3 months
* Those with acute infection and bladder stones or tumors will not be included in the study.

Primary outcomes:
measure: İncontinence Questionary at 8 weeks
timeFrame: Change from Baseline in incontinence questionary at 8 weeks
measure: Incontinence Severity Index
timeFrame: Change from Baseline in Incontinence Severity Index at 8 weeks
measure: Incontinence Quality of Life
timeFrame: Change from Baseline in Incontinence Quality of Life at 8 weeks
measure: Global Perception of Improvement
timeFrame: Change from Baseline in Global Perception of Improvement at 8 weeks
measure: Pelvic Floor Muscle Strength assessing with PERFECT
timeFrame: Change from Baseline in PERFECT degrees at 8 weeks
measure: 1 hour Pad Test
timeFrame: Change from Baseline in Pad Test at 8 weeks
measure: State-Trait Anxiety Inventory
timeFrame: Change from Baseline in State-Trait Anxiety Inventory at 8 weeks
measure: Bladder Diary
timeFrame: Change from Baseline in Bladder Diary at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Special Nova Therapy and Rehabilitation Center
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur Tuncer, PT, PhD
role: STUDY_DIRECTOR
References: