Effect of TECAR in Treating Stress Urinary Incontinence

NCT ID: NCT04612205

Last Updated: 2020-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-31
• Study Completion Date: 2021-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group A

females complain from SUI treated by TECAR and pelvic floor exercises

Group Type: EXPERIMENTAL

TECAR followed by pelvic floor exercises

Intervention Type: DEVICE

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

group B

females treated by pelvic floor exercises only

Group Type: ACTIVE_COMPARATOR

pelvic floor exercises

Intervention Type: 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.

Interventions

TECAR followed by pelvic floor exercises

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

Intervention Type: DEVICE

pelvic floor exercises

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

eman elhosary

OTHER

Sponsor Role: lead

Responsible Party

eman elhosary

assist .Prof.of women health department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

eman elhosary

Role: PRINCIPAL_INVESTIGATOR

kafr elshekh university

Central Contacts

eman elhosary

Role: CONTACT

emanabdelfatah123@yahoo.com

0021276754277

References

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.

Reference Type: DERIVED

PMID: 36687887 (View on PubMed)

Other Identifiers

tecar & stress incontinence

Identifier Type: -

Identifier Source: org_study_id