Comparing the effects of biofeedback and brain stimulation treatments on pelvic floor muscle function in women with urinary incontinence

Not Applicable

Recruiting

• Conditions: rinary incontinence.; Stress incontinence (female) (male); N39.3

• Registration Number: IRCT20230305057630N1
• Lead Sponsor: Semnan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

Women aged 35 to 70 years with urinary incontinence as the main clinical complaint, without urgent symptoms
Urine loss of more than 1 gram per hour should be confirmed by a one-hour test pad
The simultaneous presence of sexual disorders and impotence with urinary incontinence
Absence of chronic degenerative diseases that affect muscle and nerve tissues
Absence of any degree of pelvic organ prolapse (POP)
Absence of active or recurrent urinary tract infections (UTIs)
Absence of vulvovaginitis
Absence of atrophic vaginitis
Absence of copper IUD in the uterus
Absence of pregnancy or childbirth less than 6 months
Not suffering from diabetes, neurological disease, mental illness, and debilitating chronic diseases such as kidney failure and heart pacemakers.
Absence of taking drugs that affect urination
No history of surgical or drug treatment of SUI
No history of abdominal and inguinal hernia
No history of any surgery in the abdomen and pelvis (due to adhesions in the area and impact on the bladder)
Absence of constipation
No history of seizures

Exclusion Criteria

Having a urinary infection
History of cesarean section
Unwillingness to cooperate
Suffering from chronic degenerative diseases that affect muscle and nerve tissues
Presence of any degree of pelvic organ prolapse (POP)
Presence of active or recurrent urinary tract infections (UTIs)
Presence of vulvovaginitis
Presence of atrophic vaginitis
Presence of a copper IUD in the uterus
Pregnancy or childbirth less than 6 months
Having diabetes, neurological disease, mental illness and debilitating chronic diseases such as kidney failure and heart pacemaker
Presence of drugs that affect urination
History of surgical or drug treatment of SUI
History of abdominal and inguinal hernia
Having a history of any surgery in the abdomen and pelvis (due to adhesions in the area and impact on the bladder)
Presence of constipation
History of seizures

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of urinary incontinence and vaginal symptoms. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: International Consultation on Incontinence Questionnaire Vaginal Symptoms Module questionnaire.;The volume of urine loss. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: One hour pad test.

Secondary Outcome Measures

Name	Time	Method
Bladder displacement amount. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: Ultrasonography.;Strength and endurance of pelvic floor muscles. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: Perineometer.;Strength and endurance of pelvic floor muscles. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: Manual assessment with the Oxford scale.;Strength and endurance of pelvic floor muscles. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: Biofeedback.