Effect of Bilateral Transcutaneous Tibial Nerve Stimulation on Postpartum Constipation

Cairo University (CU)

Status

Not yet enrolling

Conditions

Constipation

Treatments

Other: Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices

Study type

Interventional

Funder types

Other

Identifiers

NCT05455853

P.T.Rec/012/003728

Details and patient eligibility

About

This study will be conduct to determine the effect of bilateral transcutaneous tibial nerve stimulation on treating postpartum constipation

Full description

TTNS was effective in treating constipation .It was believed that re-establishment of normal colonic function may be possible with neuromodulation of sacral nerve stimulation (SNS) that may improve constipation symptoms but it is expensive and invasive . Percutaneous tibial nerve stimulation (PTNS) is an alternative method of neuromodulation that has shown efficacy in constipation and it stimulates L4-S3 nerve roots of sacral plexus that supply the pelvic floor and lower gastrointestinal tract, Transcutaneous tibial nerve stimulation (TTNS) targets the tibial nerve in a similar fashion to PTNS but it is cheaper and does not require needle puncture .There were few studies showed that TTNS has been used and shown to be effective for treating constipation, but till now, there is no previous study illustrating it's effect specifically on postpartum constipation. So, this study will be the first one in this issue.

Enrollment

60 estimated patients

Sex

Female

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:•Postpartum women, delivered by caesarean section suffering from constipation after delivery.

Their ages will range from 20 to 35 years old.
Their body mass index (BMI) will range from 25 to 33 kg/m2.
All participating women should have at least two criteria of Rome III diagnostic criteria for constipation.

They should stop laxatives intake during treatment program

Exclusion Criteria:

Postpartum women will be excluded if they have:

History of inflammatory bowel disease, and irritable bowel syndrome.
Endocrine disease or digestive tract disease.
History of genital prolapse and anal fissure.
Congental anorectal malformation, stoma in situ.
Diabtes mellitus and sever distal venous insuffiency.
Skin eruption at the site of stimulation.
Implanted pacemaker or defibrillator.
Metalic implant in lower limb.
Recent surgery at the lower limb.
Peripheral neuropathy and neurological disorders. Psychological distress.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

bilateral transcutaneous tibial nerve stimulation,exercise and advices

Experimental group

Description:

•They will receive bilateral transcutaneous tibial nerve stimulation three times per week for 4 weeks, in addition to abdominal muscle training and breathing exercise and bowel care advices.

Treatment:

Other: Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices

Exercises and advices

Experimental group

Description:

They will perform abdominal muscle training and breathing exercise three times per week, for 4 weeks in addition to bowel care advices.

Treatment:

Other: Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices