NCT06265896

Brief Summary

This study will be conducted to evaluate the effect of kinesiotaping on activation of abdominopelvic cavity for management of stress urinary incontinence females' patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

February 10, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

February 10, 2024

Last Update Submit

February 16, 2024

Conditions

Keywords

KinesiotapingAbdominal MusclesFemale PatientsStress Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

  • Pelvic floor impact questionnaire- short form 7 (PFIQ-7)

    It will be used to evaluate the efficacy of a particular therapy, and to compare bladder, bowel or vaginal symptoms severity for all females in both groups (A\&B) before and after treatment. All of the items use the following response scale: 0, Not at all; 1, somewhat; 2, moderately; 3, quite a bit PFIQ-7 Score, Obtain the mean value for all of the answered items within the corresponding scale (possible value 0- 3) and then multiply by (100/3) to obtain the scale score (range 0-100). The final score is the sum of the scores from the 3 scales together to obtain the summary score (range 0-300).

    4 weeks

  • King's Health Questionnaire (KHQ)

    The KHQ is a validated instrument for measuring the quality of life of women with urinary incontinence. This questionnaire consists of two parts and 32 items. The first part (21 items) contains two single-item questions that address General Health Perception and Incontinence Impact and the following seven multi-item domains: Role, Physical, and Social Limitations, Limitations in Personal Relationship, Emotional Problems, Sleep and Energy Disturbances associated with SUI, and Severity Measures for UI. The second part has an 11-item Symptom Severity Scale (SSS) that assesses the presence and severity of urinary symptoms. While the entire SSS is scored from 0 (best) to 30 (worst), the minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health) for all other KHQ domains.

    4 weeks

Secondary Outcomes (1)

  • Assessment of pelvic floor muscle strength

    4 weeks

Study Arms (2)

Kinesio taping +Pelvic floor exercise training

EXPERIMENTAL

They will be treated by Elastic Kinesio-tape of (K-Active) brand which will be applied over abdomen, which will be changed every 3 days and this will be maintained along four weeks, plus conventional pelvic floor exercises; 30 minutes, 3 times/week for 12 sessions.

Other: Kinesio tapingOther: Pelvic floor exercise training

Pelvic floor exercise training

ACTIVE COMPARATOR

They will be treated by conventional pelvic floor exercises; 30 minutes, 3 times/week for 12 sessions.

Other: Pelvic floor exercise training

Interventions

Tape will be applied on rectus abdominis muscles using muscles facilitation technique from origin to insertion of muscle with a tension between 15-35%. Band will start on symphysis pubis with no tension and then women make stretch on the abdominal region by deep abdominal inspiration and will end at xiphoid process. Tape will be applied on the right and left external oblique muscles; the procedure will start without tension from bottom and of 6-12 ribs, then the hip will be placed in flexion and rotation to opposite direction and the tape will be attached to pubic bone with tension between 15-35%. Finally, the tape will be performed on the right and left internal oblique muscles; the procedure will start without tension from anterior superior iliac spine and then the hip will be placed in extension position and the tape will be attached to lower 4 ribs and linea alba with tension between 15-35%.

Kinesio taping +Pelvic floor exercise training

The intervention will be applied by a trained physical therapist. First of all, each participant will be instructed to relax thighs, bottom and abdomen musculature, then squeeze pelvic floor muscles 'focus on tightening without flexing abdomen, thighs or buttocks- avoid holding breath' 10 repetitions, 3 to 5 times a day (morning, afternoon, and night). Rest for 4 seconds and then repeat each contraction. Build up pelvic floor musculatures strength until each participant be able to do 10 slow contractions each time, holding them for 10 seconds each with rests of 4 seconds in between. Then do not hold your breath or tighten your stomach, bottom or thigh muscles at the same time. Will instruct participants to try holding each squeeze for a few seconds.

Kinesio taping +Pelvic floor exercise trainingPelvic floor exercise training

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women suffering from mild to moderate stress urinary incontinence, clinically diagnosed by the gynecologist.
  • Their ages will be ranged from 30-50 years old.
  • Their body mass index (BMI) will be ranged from (20-25 kg/m2).
  • They shouldn't have any musculoskeletal or neurological disorders.

You may not qualify if:

  • Current pregnancy.
  • Malignant condition
  • History of acute infection
  • Neurological problem
  • Mental problem to prevent evaluation and cooperation
  • Having allergies to kinesiotaping
  • Having uncontrolled metabolic diseases like diabetes and thyroid disease.
  • Athletic females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dalia M. Kamel, Prof.

    Department of Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

    STUDY CHAIR

Central Study Contacts

Mai N Mamdouh, M.Sc. student

CONTACT

Dalia M. Kamel, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (M.Sc. student)

Study Record Dates

First Submitted

February 10, 2024

First Posted

February 20, 2024

Study Start

March 1, 2024

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations