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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230228057560N1
Enrollment
87
Registered
2023-05-06
Start date
2023-05-10
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation.

Interventions

Intervention 1: Intervention group: Biofeedback. Intervention 2: Intervention group: Electrical stimulation. Intervention 3: Intervention group: Combination.

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactfatemeh oraki koohshoori

Ahvaz University of Medical Sciences

fatemehorakii@yahoo.com+98 61 3391 1287

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026