NCT05549193

Brief Summary

To investigate the effects of the pelvic floor and abdominal muscle training on the severity of incontinence in women with stress and mixed urinary incontinence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

September 12, 2022

Last Update Submit

September 21, 2022

Conditions

Keywords

Rectus AbdominusPelvic Floor Muscle TrainingStress Urinary IncontinenceQuality of LifeBiofeedbackHome Exercises

Outcome Measures

Primary Outcomes (1)

  • Urinary Incontinence Severity

    A 24-hour pad test was used to assess and standardize the severity of UI. The patients were informed before the test. The patients were told to change their pads every 4-6 hours and put the pads in an airtight locked bag to prevent the urine from evaporating. Since the pads should be weighed immediately after the evaluation, they were asked to do the test 1 day before the evaluation. Pads that were used for 24 hours were requested in a mouth-locked bag. 1 unused pad of the same type was requested. Urinary incontinence was determined by measuring the weight of the pad with precision scales (Isolab Laborgerate GMBH, Germany) before and after 24 hours. As a result of the 24-hour pad test, 4-20 grams were defined as mild, 21-74 grams as moderate, and \> 75 grams as severe UI.

    6 weeks

Secondary Outcomes (6)

  • Pelvic Floor Muscle Activity

    6 weeks

  • Abdominal Muscles Strength

    6 weeks

  • Quality of life about Urinary Incontinence

    6 weeks

  • Urinary Incontinence Symptom severity

    6 weeks

  • Existing pelvic floor dysfunction

    6 weeks

  • +1 more secondary outcomes

Study Arms (1)

Mild and Moderate-Severe Urinary Incontinence Group

EXPERIMENTAL

10 sets of pelvic floor muscle training and 2 sets of abdominal muscle strengthening training were given every day for 6 weeks. All analyzes were conducted at the beginning and end of the 6-week training. The same training program was applied to both groups ( Group 1 (mild urinary incontinence) and Group 2 (moderate-severe urinary incontinence), and the effects were compared according to the severity of incontinence.

Other: Exercises Training

Interventions

Pelvic Floor Muscle Training: For slow contractions, it was asked to contract in 5 seconds gradually, wait at a maximum of 5 seconds and gradually relax in 5 seconds. For fast contractions, it was asked to contract at a maximum of 2 seconds and then to relax. 10 fast + 10 slow contractions were accepted as 1 set exercise. (10 sets x Every Day x 6 weeks) Transversus Abdominus: Patients were in the crook lying position and were asked to contract their abdominal muscles strongly and statically. 15 repetitions were carried out, each consisting of contraction for 10 s and relaxation for 20 s. 2 sets of 15 repetitions were done. Internal Obliquus Abdominus: Patients were in the crook lying position and were asked to contract their abdominal muscles strongly and statically and then try to touch the furthest point of their legs with their fingertips for 15 repetitions consisting of contraction for 10 s followed by relaxation for 20 s. The sequence was then repeated on the other leg.

Mild and Moderate-Severe Urinary Incontinence Group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients with incontinence diagnoses were referred by the doctor. Gender identity is based on patients' self-representation and anatomical structures.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being female,
  • Being 18 years of age or older
  • Having been diagnosed of SUI and stress-predominant MUI after urodynamic evaluation by the urologist.

You may not qualify if:

  • Currently taking medications for UI,
  • Having urinary tract infection,
  • Neurological disorders,
  • Pelvic organ prolapse stage \>2,
  • Pregnancy,
  • a mental problem and/or
  • been applied prior to physiotherapy for UI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary IncontinenceUrinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 22, 2022

Study Start

November 28, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

September 23, 2022

Record last verified: 2022-09

Locations