Effect of TECAR in Treating Stress Urinary Incontinence

NCT04612205 | Unknown

• 1 other identifier: tecar & stress incontinence
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Stress urinary incontinence (SUI) is the defined as a leakage of urine with physical exertion, most commonly from coughing, laughing, or sneezing. It has a profound psychosocial impact not only to patients but also on their families and caregivers, resulting in loss of self stem, sexual dysfunction.Because of the higher incidence of stress urinary incontinence that reach 30% of women during childbearing period, 50% in elderly women, and its social embarrassing condition causing socio-psychological problems, disability and dependency with higher economic impact and based on TECAR therapy had better recovery of muscle strength and function in addition to there is no study has evaluated the impact of TECAR treatment on stress urinary incontinence, our study aim to assess the effectiveness of TECAR in treatment of such cases to decrease time of treatment and provide good results to patients.

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence, TECAR

Outcome Measures

Primary Outcomes (1)

• strength of pelvic floor

  strength of pelvic floor muscles measured by perineometer before treatment and after 4 weeks

  after 4 week

Secondary Outcomes (1)

• severity of SUI

  after 4 weeks

Study Arms (2)

group A

EXPERIMENTAL

females complain from SUI treated by TECAR and pelvic floor exercises

Device: TECAR followed by pelvic floor exercises

group B

ACTIVE COMPARATOR

females treated by pelvic floor exercises only

Other: pelvic floor exercises

Interventions

TECAR followed by pelvic floor exercises DEVICE

The signal generator was an INDIBA® 448 kHz RF device (vagina/rectum) (INDIBA SA, Barcelona, Spain).

group A

pelvic floor exercises OTHER

The patients will instructed to contract their pelvic floor muscles without contracting adjacent muscles, such as the abdomen, glutei and hip adductors muscles twenty repletion consisted of contraction and squeezing of the muscle ten seconds followed by relaxation for twenty second then rested for two minutes. The exercises program lasted for lasting 45 min. divided into 5 min. warming up, 35 min. actual treatment and 5 min. cooling down, three times a week for eight consecutive weeks. The patient will teach to contract their pelvic floor muscles before coughing or sneezing thus to prevent leakage. Home exercises through continuing practicing these contractions as frequent as possible according to her ability, at early morning before getting from bed from crock lying position, at afternoon from sitting and standing positions, at evening from sitting and standing positions and finally at night at bed time from crock lying position.

group B

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Those with neurological diseases, diabetic neuropathy, congenital urologic disease, bladder cancer and neurogenic bladder, detrusor hyperactivity and bladder or urethra previous surgery

Sponsors & Collaborators

• eman elhosary: lead

Related Publications (1)

• Elhosary EA, Ahmed Hamada H, Ali AlMubali F, Lopez Sanchez GF, Ahmed SM. Effect of monopolar capacitive resistive radiofrequency in treating stress urinary incontinence: A pilot randomized control trial. Front Psychol. 2023 Jan 5;13:1062363. doi: 10.3389/fpsyg.2022.1062363. eCollection 2022.

  PMID: 36687887 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• eman elhosary

  kafr elshekh university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

eman elhosary

CONTACT

0021276754277; emanabdelfatah123@yahoo.com

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: SPONSOR INVESTIGATOR
• PI Title: assist .Prof.of women health department

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 2, 2020
• Study Start: December 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share