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Comparison of Two Different Pelvic Floor Muscle Training Programs in Stress Urinary Incontinence

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ClinicalTrials.gov Identifier: NCT05293886
Recruitment Status : Not yet recruiting
First Posted : March 24, 2022
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
SERAP ÖZGÜL, Hacettepe University

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.


Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Other: Classical Pelvic Floor Muscle Training Other: Functional Pelvic Floor Muscle Training Not Applicable

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 informations, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of The Effects of Two Different Pelvic Floor Muscle Training Programs in Women With Stress Urinary İncontinence
Estimated Study Start Date : April 15, 2022
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Classical Pelvic Floor Muscle Training
In the first 2 weeks of classical pelvic floor muscle training, individuals will perform 3 sets of 10 maximal voluntary pelvic floor muscle contraction exercises and 20 submaximal voluntary pelvic floor muscle contraction exercises per day. In every 2-week control, the number of sets will be increased by one set.
Other: Classical Pelvic Floor Muscle Training
In the first 2 weeks of classical pelvic floor muscle training, individuals will perform 3 sets of 10 maximal voluntary pelvic floor muscle contraction exercises and 20 submaximal voluntary pelvic floor muscle contraction exercises per day. In every 2-week control, the number of sets will be increased by one set.

Experimental: Functional Pelvic Floor Muscle Training
Functional pelvic floor muscle training will be started with 3 exercises (toe tap, bridge and clamshall exercises), each exercise will be performed with 1 set and 30 repetitions. In every 2-week control, the number of exercises will be increased by one. Cat-cow exercise will be added at 3-4th weeks, squats will be added at 5-6th weeks, and lunges will be added at 7-8th weeks.
Other: Functional Pelvic Floor Muscle Training
Functional pelvic floor muscle training will be started with 3 exercises (toe tap, bridge and clamshall exercises), each exercise will be performed with 1 set and 30 repetitions. In every 2-week control, the number of exercises will be increased by one. Cat-cow exercise will be added at 3-4th weeks, squats will be added at 5-6th weeks, and lunges will be added at 7-8th weeks.




Primary Outcome Measures :
  1. Change in Symptom Severity and Impact of Incontinence on Life [ Time Frame: Change in International Urinary Incontinence Consultation Questionnaire Short Form score from baseline to end of 8th week ]
    International Urinary Incontinence Consultation Questionnaire Short Form (ICIQ-UI SF) will be used to evaluate the change in symptom severity and impact of incontinence on life


Secondary Outcome Measures :
  1. Incontinence Severity [ Time Frame: Change in incontinence severity from baseline to end of 8th week ]
    1-hour pad test will be used to evaluate the incontinence severity

  2. The Impact of Incontinence on Quality of Life [ Time Frame: Change in King Health Questionnaire score from baseline to end of 8th week ]
    King Health Questionnaire will be used to evaluate the effect of incontinence on quality of life

  3. Participant's Perception of Symptom Severity [ Time Frame: Change in Patient Global Impression of Severity Scale score from baseline to end of 8th week ]
    Patient Global Impression of Severity Scale will be used to evaluate the participant's perception of symptom severity

  4. Participant's Perception of Recovery [ Time Frame: Change in Patient Global Impression of Change Scale score from baseline to end of 8th week ]
    Patient Global Impression of Change Scale will be used to evaluate the participant's perception of recovery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05293886


Contacts
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Contact: Serap Özgül, PhD +905339390803 serapky@yahoo.com

Locations
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Turkey
Berna Tokmak
Ankara, Turkey, 06100
Contact: Berna Tokmak    +905549007869    bernatokmak06@gmail.com   
Sub-Investigator: Türkan Akbayrak         
Sub-Investigator: Nejat Özgül         
Sub-Investigator: Ceren Gürsen         
Sub-Investigator: Gamze N. Çinar         
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Serap Özgül, Assoc Prof Hacettepe University
Publications:

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Responsible Party: SERAP ÖZGÜL, Doc. Dr., Hacettepe University
ClinicalTrials.gov Identifier: NCT05293886    
Other Study ID Numbers: KA-21107
First Posted: March 24, 2022    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders