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

Primary Purpose

Stress Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Classical Pelvic Floor Muscle Training
Functional Pelvic Floor Muscle Training
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Berna TokmakRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Classical Pelvic Floor Muscle Training

Functional Pelvic Floor Muscle Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Symptom Severity and Impact of Incontinence on Life by International Urinary Incontinence Consultation Questionnaire Short Form
International Urinary Incontinence Consultation Questionnaire Short Form will be used to evaluate the change in symptom severity and impact of incontinence on life. Score ranges are 1-5 (slight), 6- 2 (moderate), 13-18 (severe) and 19-21 (very severe). Lower scores mean a better outcome for this questionnaire form.

Secondary Outcome Measures

Incontinence Severity by 1-hour pad test
1-hour pad test will be used to evaluate the incontinence severity. There is no minimum and maximum values. Lower scores mean a better outcome.
The Impact of Incontinence on Quality of Life by King Health Questionnaire
King Health Questionnaire will be used to evaluate the effect of incontinence on quality of life. Minimum value is 0 and maximum value is 130. Lower scores mean a better outcome.
Participant's Perception of Symptom Severity by Patient Global Impression of Severity Scale
Patient Global Impression of Severity Scale will be used to evaluate the participant's perception of symptom severity. Score ranges are 1 to 4. Lower scores mean a better outcome.
Participant's Perception of Recovery by Patient Global Impression of Change Scale
Patient Global Impression of Change Scale will be used to evaluate the participant's perception of recovery. Score ranges are 1 to 7. Lower scores mean a better outcome.

Full Information

First Posted
March 15, 2022
Last Updated
September 7, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05293886
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Classical Pelvic Floor Muscle Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Functional Pelvic Floor Muscle Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Classical Pelvic Floor Muscle Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Functional Pelvic Floor Muscle Training
Intervention Description
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 Measure Information:
Title
Change in Symptom Severity and Impact of Incontinence on Life by International Urinary Incontinence Consultation Questionnaire Short Form
Description
International Urinary Incontinence Consultation Questionnaire Short Form will be used to evaluate the change in symptom severity and impact of incontinence on life. Score ranges are 1-5 (slight), 6- 2 (moderate), 13-18 (severe) and 19-21 (very severe). Lower scores mean a better outcome for this questionnaire form.
Time Frame
Change in International Urinary Incontinence Consultation Questionnaire Short Form score from baseline to end of 8th week
Secondary Outcome Measure Information:
Title
Incontinence Severity by 1-hour pad test
Description
1-hour pad test will be used to evaluate the incontinence severity. There is no minimum and maximum values. Lower scores mean a better outcome.
Time Frame
Change in incontinence severity from baseline to end of 8th week.
Title
The Impact of Incontinence on Quality of Life by King Health Questionnaire
Description
King Health Questionnaire will be used to evaluate the effect of incontinence on quality of life. Minimum value is 0 and maximum value is 130. Lower scores mean a better outcome.
Time Frame
Change in King Health Questionnaire score from baseline to end of 8th week.
Title
Participant's Perception of Symptom Severity by Patient Global Impression of Severity Scale
Description
Patient Global Impression of Severity Scale will be used to evaluate the participant's perception of symptom severity. Score ranges are 1 to 4. Lower scores mean a better outcome.
Time Frame
Change in Patient Global Impression of Severity Scale score from baseline to end of 8th week.
Title
Participant's Perception of Recovery by Patient Global Impression of Change Scale
Description
Patient Global Impression of Change Scale will be used to evaluate the participant's perception of recovery. Score ranges are 1 to 7. Lower scores mean a better outcome.
Time Frame
Change in Patient Global Impression of Change Scale score from baseline to end of 8th week.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serap Özgül, PhD
Phone
+905339390803
Email
serapky@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serap Özgül, Prof
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Berna Tokmak
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berna Tokmak
Phone
+905549007869
Email
bernatokmak06@gmail.com
First Name & Middle Initial & Last Name & Degree
Türkan Akbayrak
First Name & Middle Initial & Last Name & Degree
Nejat Özgül
First Name & Middle Initial & Last Name & Degree
Ceren Gürsen
First Name & Middle Initial & Last Name & Degree
Gamze N. Çinar

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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27918122
Citation
Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Neurourol Urodyn. 2017 Feb;36(2):221-244. doi: 10.1002/nau.23107. Epub 2016 Dec 5.
Results Reference
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1202204
Citation
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Results Reference
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Results Reference
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PubMed Identifier
3796918
Citation
Jorgensen L, Lose G, Andersen JT. One-hour pad-weighing test for objective assessment of female urinary incontinence. Obstet Gynecol. 1987 Jan;69(1):39-42.
Results Reference
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PubMed Identifier
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Citation
Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.
Results Reference
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9422015
Citation
Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1997 Dec;104(12):1374-9. doi: 10.1111/j.1471-0528.1997.tb11006.x.
Results Reference
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Kaya S, Akbayrak T, Toprak Celenay S, Dolgun A, Ekici G, Beksac S. Reliability and validity of the Turkish King's Health Questionnaire in women with urinary incontinence. Int Urogynecol J. 2015 Dec;26(12):1853-9. doi: 10.1007/s00192-015-2786-6. Epub 2015 Jul 26.
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Fischer MC, Huckabay C, Nitti VW. The male perineal sling: assessment and prediction of outcome. J Urol. 2007 Apr;177(4):1414-8. doi: 10.1016/j.juro.2006.11.061.
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Comparison of Two Different Pelvic Floor Muscle Training Programs in Stress Urinary Incontinence

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