]>
IRCT20230228057560N1 IRCT 2023-05-06 Ahvaz University of Medical Sciences Treatment of women with constipation and urinary incontinence Comparison of biofeedback therapy and posterior tibial nerve stimulation alone versus combined treatment on improving pelvic floor muscle activity, sign and quality of life in femals with chronic dyssynergic constipation and stress urinary incontinence: asingle blind randomized controlled trial 2023-05-10 anticipated 87 Complete https://irct.ir/trial/68960 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Health service research, Blinding description: In order to select the participants in this study, we will conduct subsequent sampling through sorting through background variables. We divide people into three groups based on the randomization table. One group receives biofeedback treatment alone, one group receives tibial nerve electrical stimulation treatment alone, and the other group receives combined biofeedback and tibial nerve electrical stimulation treatment. N/A Constipation. Intervention 1: Intervention group: Biofeedback. Intervention 2: Intervention group: Electrical stimulation. Intervention 3: Intervention group: Combination. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because pelvic floor disorders are taboo
public fatemeh oraki koohshoori
No. 81,6 West Ave., Kyanpars Blvd
ahwaz Iran (Islamic Republic of) 6155844474 +98 61 3391 1287 fatemehorakii@yahoo.com Ahvaz University of Medical Sciences scientific fatemeh oraki koohshoori
No. 81,6 West Ave,, Kyanpars Blvd
Ahwaz Iran (Islamic Republic of) 6155844474 +98 61 3391 1287 fatemehorakii@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 60 Concomitant presence of constipation and stress urinary incontinence At least 12 months have passed since symptoms Have not responded to standard medical treatments for constipation and adherence to diet not receiveing treatment regarding these two disorders. Having at least two Criterion of the Rome IV criteria 18 years 60 years Female Unsuccessful history of biofeedback therapy Uncontrolled cardiovascular, kidney and liver diseases Back, hip and/or hip joint dysfunction Diabetes Chronic obstructive pulmonary disease Sexual problems Use of medications (diuretics, sympathomimetics/sympatholytic), parasympathomimetic / parasympatholytic) Spinal cord injury Patients with a history of mental illness Drug-induced constipation Metabolic, endocrine, neurological disorders History of pelvic surgery Pregnancy Active intestinal disease and fissure Neurological diseases (such as multiple sclerosis, stroke) Urine test and positive urine culture History of radiation therapy or hormone therapy in the last six months Prolapse of the pelvic organs more than grade 2 (more than 1 cm below Hyman's membrane during the examination in the stretched state of the pelvic floor. Grading will be done through the quantitative system of pelvic organ prolapse and by a gynecologist or pelvic floor physiotherapist. This The method has 5 grades from grade 0 to 4, grade 0 indicates the absence of prolapse, grade 1 is less than 1 cm below Hyman's curtain, grade 2 is more than 1 cm below Hyman's curtain, grade 3 is more than 1 cm. below the hymen, but does not protrude more than 2 cm from the entire length of the vagina, and in grade 4, the lower genital system is completely deviated They were not able to contract the pelvic floor muscles during finger examination Active or recurrent urinary tract infection Rehabilitation Rehabilitation Rehabilitation Intervention group: Biofeedback Intervention group: Electrical stimulation Intervention group: Combination Quality of life. Timepoint: At the beginning of treatment, every five sessions, at the end of treatment and three months after treatment. Method of measurement: Questionnaires. Treatment time. Timepoint: At the beginning of treatment, every five sessions, at the end of treatment and three months after treatment. Method of measurement: GEE model. Frequency of incontinence. Timepoint: At the beginning of treatment, every five sessions, at the end of treatment and three months after treatment. Method of measurement: Three day bladder diary. Activity of pelvicfloor muscles. Timepoint: At the beginning of treatment, every five sessions, at the end of treatment and three months after treatment. Method of measurement: Examining the strength, resting tone, resting activity and sneezing or coughing pelvic floor muscles through electromyography. Quality of life. Timepoint: First session, every five sessions, end of treatment and three months after treatment. Method of measurement: Questionnaires. Pelvic floor muscle activity. Timepoint: First session, every five sessions, end of treatment and three months after treatment. Method of measurement: Electromyography. Treatment time. Timepoint: First session, every five sessions, end of treatment and three months after treatment. Method of measurement: GEE model. Frequency of incontinence. Timepoint: First session, every five sessions, end of treatment and three months after treatment. Method of measurement: Three day bladder diary. Ahvaz University of Medical Sciences Approved 2023-04-08 Ethics committee of Ahwaz Jundi shapoor univercity of medical sciences No 81, 6 West Ave, Kyan pars Blvd Ahwaz Khouzestan Iran (Islamic Republic of)