Clinical trial NCT05293886: Comparison of Two Different Pelvic Floor Muscle Training Programs in Stress Urinary Incontinence
Official title: Comparison of The Effects of Two Different Pelvic Floor Muscle Training Programs in Women With Stress Urinary İncontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pelvic floor muscle training (PFMT) is indicated as a first-line treatment for stress urinary incontinence. PFMT aims to improve pelvic floor muscle strength, endurance and relaxation ability or a combination of these. PFMT is a structured and customized exercise program. Pelvic floor muscles work in synchronization with many muscles and pelvic floor muscle function is supported by synergistic muscles. Relationships between the functions of pelvic floor muscles and synergistic muscle groups have been reported in the literature. However, studies comparing the efficacy of PFMT and combined training of these muscles are limited and more studies are needed.

Therefore the aim of this study is to compare the effects of isolated PFMT and functional PFMT in women with stress urinary incontinence.

Detailed description: Our study is designed as a parallel group, randomized clinical trial. Participants who meet the inclusion criteria will be assigned randomly to one of the study groups. The participants in the 1st group will be given classical PFMT, and the participants in the 2nd group will be given functional PFMT. The study period is 8 weeks for each individual participating in the study. All participants will be called for control every 2 weeks and progress will be made in exercise programs in accordance with the protocol.

At the beginning of the study, demographic information, physical characteristics, smoking habit, primary and secondary urinary symptoms and their duration, obstetric history, menstrual and menopausal status, comorbidities, drugs used and, if any, the effects of these drugs on the urinary system, previous UI treatments and their duration will be recorded.

For individuals over 65 years of age, Mini Mental Test will be applied in terms of cooperation suitability for the research.

The objective severity of incontinence will be assessed with the 1-hour pad test. The subjective severity of incontinence and its impact on life will be evaluated with the International Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF). The King's Health Questionnaire (KHQ) will be used to investigate the effects of interventions on the sub-dimensions of quality of life. With the Patient Global Impression of Severity Scale and the Patient Global Impression of Change Scale, the individual's perception of severity and recovery of UI will be evaluated. Vaginal palpation will be performed to determine whether individuals can voluntarily contract their pelvic floor muscles and to teach correct contraction before pelvic floor muscle training. Outcome measurements will be recorded at the beginning of the study, at the end of the 4th week and at the end of the 8th week. Participants will be given an exercise diary to increase motivation and exercise adherence.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from stress urinary incontinence or SUI predominant Mixed Urinary Incontinence according to the 3 Incontinence Questionnaire (3IQ)
* Body mass index \<35 kg/m²
* Individuals over the age of 18 (with a Mini Mental Test score ≥ 24 for individuals over the age of 65)

Exclusion Criteria:

* Patients with pure urge incontinence, urge predominant mixed urinary incontinence or neurogenic bladder
* Pregnancy or suspected of pregnancy
* Those who have given birth in the last 1 year
* Being virgin
* Those who have had abdomino-pelvic surgery in the last 6 months, and/or those who have received abdomino-pelvic radiotherapy
* Those with urinary tract infection, recurrent urinary tract infection, diagnosis of interstitial cystitis
* Any orthopedic problem that will hinder exercise
* Patients over 65 years of age with a mini mental test score \< 24
* Patients with Pelvic Organ Prolapse grade ≥ Stage 2
* Those who have received treatment for urinary incontinence in the last 6 months
* Those who have uncontrolled diabetes and hypertension, severe systemic disease
* Those who have a neurological disease that will affect the urinary system
* Those who have started a new drug that will affect bladder functions in the last 1 month
* The strength of the pelvic floor muscles in digital examination is \<2 according to the Modified Oxford Scale score.

Primary outcomes:
measure: Change in Symptom Severity and Impact of Incontinence on Life by International Urinary Incontinence Consultation Questionnaire Short Form
timeFrame: Change in International Urinary Incontinence Consultation Questionnaire Short Form score from baseline to end of 8th week
Secondary outcomes:
measure: Incontinence Severity by 1-hour pad test
timeFrame: Change in incontinence severity from baseline to end of 8th week.
measure: The Impact of Incontinence on Quality of Life by King Health Questionnaire
timeFrame: Change in King Health Questionnaire score from baseline to end of 8th week.
measure: Participant's Perception of Symptom Severity by Patient Global Impression of Severity Scale
timeFrame: Change in Patient Global Impression of Severity Scale score from baseline to end of 8th week.
measure: Participant's Perception of Recovery by Patient Global Impression of Change Scale
timeFrame: Change in Patient Global Impression of Change Scale score from baseline to end of 8th week.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Berna Tokmak
Study officials:
affiliation: Hacettepe University
name: Serap Özgül, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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