Protocol summary

Study aim
The aim of this study is to provide an effective treatment method to reduce symptoms, reduce treatment duration, increase quality of life and thus reduce treatment costs in patients with simultaneous disorder of chronic dyssynergic constipation and stress urinary incontinence.
Design
In this clinical trial study, 87 people will be selected according to the entry criteria and data will be collected. we will conduct subsequent sampling through sorting through background variables. We divide people into three groups based on the randomization table.
Settings and conduct
Biofeedback:coordination between abdominal muscles and the pelvic floor.From the 7 session, the treatment goes to computer games, the treatment will be 15 sessions and 3 sessions every week for 20 minutes in each session. In the Ectrical stimulation method, it is a bilateral method with a frequency of 10-14 and a diversion of 200-220 , for 15 sessions, 3 sessions of 30 minutes each week. The Combination group will receive both treatments. Ahvaz Rehabilitation Faculty.
Participants/Inclusion and exclusion criteria
Women with the simultaneous disorder of chronic dyssynergic constipation and stress urinary incontinence are included in the study, People with diseases and interfering drugs are excluded.
Intervention groups
Biofeedback group therapy alone Tibial nerve electrical stimulation treatment group alone The other group combined treatment of biofeedback and electrical stimulation of the tibial nerve
Main outcome variables
Determining and comparing the effect of electrical stimulation, biofeedback and combined treatment on the quality of life, the amount of urine output, the level of pelvic floor muscle activity and the duration of treatment in women with simultaneous disorders of chronic dyssynergic constipation and stress urinary incontinence.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230228057560N1
Registration date: 2023-05-06, 1402/02/16
Registration timing: prospective

Last update: 2023-05-06, 1402/02/16
Update count: 0
Registration date
2023-05-06, 1402/02/16
Registrant information
Name
FATEMEH oraki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 1287
Email address
fatemehorakii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-10, 1402/02/20
Expected recruitment end date
2024-03-10, 1402/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Treatment of women with constipation and urinary incontinence
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 87
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahwaz Jundi shapoor univercity of medical sciences
Street address
No 81, 6 West Ave, Kyan pars Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6155844474
Approval date
2023-04-08, 1402/01/19
Ethics committee reference number
IR.AJUMS.REC.1402.006

Health conditions studied

1

Description of health condition studied
Constipation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
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

Secondary outcomes

1

Description
Quality of life
Timepoint
First session, every five sessions, end of treatment and three months after treatment
Method of measurement
Questionnaires

2

Description
Pelvic floor muscle activity
Timepoint
First session, every five sessions, end of treatment and three months after treatment
Method of measurement
Electromyography

3

Description
Treatment time
Timepoint
First session, every five sessions, end of treatment and three months after treatment
Method of measurement
GEE model

4

Description
Frequency of incontinence
Timepoint
First session, every five sessions, end of treatment and three months after treatment
Method of measurement
Three day bladder diary

Intervention groups

1

Description
Intervention group: Biofeedback
Category
Rehabilitation

2

Description
Intervention group: Electrical stimulation
Category
Rehabilitation

3

Description
Intervention group: Combination
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Musculoskeletal Research Center, Jundishapur Rehabilitation Faculty, Ahvaz
Full name of responsible person
Fatemeh Oraki koohshoori
Street address
N0. 81, 6 West Ave, Kyanpars Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6155844474
Phone
+98 61 3391 1287
Email
fatemehorakii@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Vice President of Research and Technologyجم
Street address
farvardin blvd, holesta , jundishapoor university
City
ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
fatemehoraki@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
fatemeh oraki koohshoori
Position
PHD physiotherapy student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 81,6 West Ave., Kyanpars Blvd
City
ahwaz
Province
Khouzestan
Postal code
6155844474
Phone
+98 61 3391 1287
Email
fatemehorakii@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
fatemeh oraki koohshoori
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 81,6 West Ave,, Kyanpars Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6155844474
Phone
+98 61 3391 1287
Email
fatemehorakii@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh oraki koohshoori
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 81, 6 West Ave, Kyanpars Blvd
City
ahwaz
Province
Khouzestan
Postal code
6155844474
Phone
098 61 33911287
Email
fatemehorakii@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because pelvic floor disorders are taboo
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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