ConstipationNCT05455853
Effect of Bilateral Transcutaneous Tibial Nerve Stimulation on Postpartum Constipation
A study testing Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices in people with Constipation, run by Cairo University.
Trial summary
This study will be conduct to determine the effect of bilateral transcutaneous tibial nerve stimulation on treating postpartum constipation Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 11Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
This study will be conduct to determine the effect of bilateral transcutaneous tibial nerve stimulation on treating postpartum constipation
Read the detailed 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.
- Conditions
- Constipation
- Being tested
- Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advicesOther
Also called Exercises and advices
- First group they will receive morning bilateral transcutaneous tibial nerve stimulation, for 30 minutes, three times per week for 4 weeks, in addition to abdominal muscle training and breathing exercise for 15 minutes three times per week, for 4 weeks and bowel care advices.•They will perform abdominal muscle training and breathing exercise, for 15 minutes three times per week, for 4 weeks in addition to bowel care advices.
Second group•They will perform abdominal muscle training and breathing exercise, for 15 minutes three times per week, for 4 weeks in addition to bowel care advices.
| Study group | Role | What they receive |
|---|---|---|
| bilateral transcutaneous tibial nerve stimulation,exercise and advices | Experimental | •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. Receives: Other: Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices |
| Exercises and advices | Experimental | They will perform abdominal muscle training and breathing exercise three times per week, for 4 weeks in addition to bowel care advices. Receives: Other: Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Bristol Stool Form Scale (BSFS)
It is a formal research tool used to assess stool consistency and intestinal transit rate. It is an ordinal scale used to rate and categorize stool into seven classifications, according to stool consistency It is also useful in evaluating the effectiveness of an intervention for gastrointestinal tract disease and clinical assessment. It helps people to report on stool consistency adequately, thus proving a guide in the diagnosis and treatment of gastrointestinal disorders.It classifies stool into seven categories ranging from hard lumps like nuts stool (type 1) to watery without solid pieces, entirely liquid (type 7). Types 1 and 2 are indicative of constipation, types 3 and 4 are considered normal stool consistency that is easy to defecate, while types 6 and 7 are considered abnormal consistency .
Measured: up to 4 weeks
Patient Assessment of Constipation -Symptom Questionnaire (PAC-SYM)
It is frequently used in clinical trials of constipation, it has emerged as an important tool for assessing the severity of patient-reported symptoms of constipation. It consists of 12-item questionnaire that divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden. Observational data have shown that PAC-SYM questionnaire has internal consistency, test-retest reliability and concurrent validity, and to be responsive to change over time .
Measured: up to 4 weeks
Patient Assessment of constipation quality of life questionnaire (PAC-QOL)
The validated PAC-QOL questionnaire consists of 28 items grouped into 4 subscales ; physical discomfort , psychosocial discomfort, in addition to worries and concerns, and satisfaction, investigating the effects of constipation on the patient's quality of life in the recent 2 weeks. The first three subscale comprise the patient dissatisfaction index (where higher great corresponding to worse quality of life) the satisfaction subscale include 4 items, (where higher great corresponding to improve quality of life .
Measured: up to 4 weeks
Rome III criteria: Rome III criteria: Rome III criteria
It will be used to confirm the diagnosis of constipation for all participating women in both groups A and B to ensure that they will meet the eligibility criteria . All women should have at least two of the following criteria:
Fewer than three spontaneous bowel movements per week. Straining during at least 25% of defecation attempts. Lumpy or hard stools for at least 25% of defecation attempts. Sensation of anorectal obstruction or blockage for at least 25% of defecation attempts.
Sensation of incomplete defecation for at least 25% of defecation attempts. Manual maneuvering required to defecate for at least 25% of defecation attempts (e.g., digital evacuation, support of the pelvic floor).
Loose stools are rarely present without the use of laxatives.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, walaa salah mohammed ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455853
- Sponsor's protocol ID
- P.T.Rec/012/003728
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Transcutaneous Tibial Nerve Stimulation on Postpartum Constipation
- ClinicalTrials.gov ID
- NCT05455853
- Acronym / sponsor ID
- P.T.Rec/012/003728
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conduct to determine the effect of bilateral transcutaneous tibial nerve stimulation on treating postpartum constipation
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bilateral transcutaneous tibial nerve stimulation,exercise and advices | Experimental | Other: Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices•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. |
| Exercises and advices | Experimental | Other: Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advicesThey will perform abdominal muscle training and breathing exercise three times per week, for 4 weeks in addition to bowel care advices. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advicesAlso: Exercises and advices• First group they will receive morning bilateral transcutaneous tibial nerve stimulation, for 30 minutes, three times per week for 4 weeks, in addition to abdominal muscle training and breathing exercise for 15 minutes three times per week, for 4 weeks and bowel care advices.•They will perform abdominal muscle training and breathing exercise, for 15 minutes three times per week, for 4 weeks in addition to bowel care advices. Second group•They will perform abdominal muscle training and breathing exercise, for 15 minutes three times per week, for 4 weeks in addition to bowel care advices. | Other | Exercises and advices, bilateral transcutaneous tibial nerve stimulation,exercise and advices |
Primary outcome
The Bristol Stool Form Scale (BSFS)
Time frame: up to 4 weeks
It is a formal research tool used to assess stool consistency and intestinal transit rate. It is an ordinal scale used to rate and categorize stool into seven classifications, according to stool consistency It is also useful in evaluating the effectiveness of an intervention for gastrointestinal tract disease and clinical assessment. It helps people to report on stool consistency adequately, thus proving a guide in the diagnosis and treatment of gastrointestinal disorders.It classifies stool into seven categories ranging from hard lumps like nuts stool (type 1) to watery without solid pieces, entirely liquid (type 7). Types 1 and 2 are indicative of constipation, types 3 and 4 are considered normal stool consistency that is easy to defecate, while types 6 and 7 are considered abnormal consistency .
Patient Assessment of Constipation -Symptom Questionnaire (PAC-SYM)
Time frame: up to 4 weeks
It is frequently used in clinical trials of constipation, it has emerged as an important tool for assessing the severity of patient-reported symptoms of constipation. It consists of 12-item questionnaire that divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden. Observational data have shown that PAC-SYM questionnaire has internal consistency, test-retest reliability and concurrent validity, and to be responsive to change over time .
Patient Assessment of constipation quality of life questionnaire (PAC-QOL)
Time frame: up to 4 weeks
The validated PAC-QOL questionnaire consists of 28 items grouped into 4 subscales ; physical discomfort , psychosocial discomfort, in addition to worries and concerns, and satisfaction, investigating the effects of constipation on the patient's quality of life in the recent 2 weeks. The first three subscale comprise the patient dissatisfaction index (where higher great corresponding to worse quality of life) the satisfaction subscale include 4 items, (where higher great corresponding to improve quality of life .
Rome III criteria: Rome III criteria: Rome III criteria
Time frame: up to 4 weeks
It will be used to confirm the diagnosis of constipation for all participating women in both groups A and B to ensure that they will meet the eligibility criteria . All women should have at least two of the following criteria: Fewer than three spontaneous bowel movements per week. Straining during at least 25% of defecation attempts. Lumpy or hard stools for at least 25% of defecation attempts. Sensation of anorectal obstruction or blockage for at least 25% of defecation attempts. Sensation of incomplete defecation for at least 25% of defecation attempts. Manual maneuvering required to defecate for at least 25% of defecation attempts (e.g., digital evacuation, support of the pelvic floor). Loose stools are rarely present without the use of laxatives.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices in people with Constipation, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manal Ahmed El-Shafei, Lecturer (01220664518, manalpt1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Bristol Stool Form Scale (BSFS) (time frame: up to 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.