Bowel IncontinenceUSGMSNCT07239076
Unstimulated Gluteus Maximus Sphincteroplasty for Treatment of Bowel Incontinnence Case Series Study
A study testing Unstimulated gluteus maximus sphincteroplasty in people with Bowel Incontinence, run by Assiut University at 1 site in Egypt.
Trial summary
Unstimlated gluteus maximus sphincteroplasty for treatment of bowle incontinence Read more about this study
- Who is it for?
- Ages 9 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Incontinence
- What is being tested?
- Unstimulated gluteus maximus sphincteroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients with severe fecal incontinence refractory to medical treatment
- loss of native anal sphincter confirmed by MRI
- patients deemed suitable for unstimulated gluteus maximus sphincteroplasty
Who cannot join
- amyotrophic lateral sclerosis
- severe scarring of bilateral gluteus maximus
- pelvic fracture with injury of internal illiac vessels
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gamal Abdelhamid Professor dr gamal, Professor doctor contact
Egypt1 site, 1 recruiting
- Recruiting
Assiut hospital university
Asyut, University, 172000
Mahmoud Refaat Shehata, Assistant professor, 01060559662, Drmahmoudrefaat@aun.edu.eg
Ahmed Sadek Mohamed, Specialist, 01004542455, Ahmed.s.aboalhasan@aun.edu.eg
About this study
Official title: Unstimulated Gluteus Maximus Sphincteroplasty for Treatment of Bowel Incontinence
Unstimlated gluteus maximus sphincteroplasty for treatment of bowle incontinence
Read the detailed description
Surgery to treat patient with bowel incontinence by using unstimulated gluteus maximus muslce in creating neosphincter by dicussating lower third of muscle with neovascular bundle and suturing on contralateral side ischial tuberosity
- Conditions
- Bowel Incontinence
- Being tested
- Unstimulated gluteus maximus sphincteroplasty
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unstimulated gluteus maximus sphincteroplastyProcedure or surgery
Surgery done under general anethesia prone jacknige postion .. incsion made along lower gluteal crease to take lower third fibers including neurovascular bundle and dicussating subcutaneusly around anus and suturing on contralateral ischial tuberosity
| Study group | Role | What they receive |
|---|---|---|
| Age not below 9 years | Experimental | Surgery target people not below the age of 9 yearsLower gluteal crease incision and lower third fibers taken with neovascular bundle and suturing on contralateral ischial tuberosity to make external sphincter and make neosphincter Receives: Procedure: Unstimulated gluteus maximus sphincteroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of fecal incontinence
Improvement of fecal incontince assessed by cleveland clinic florida fecal incontinnence score <7
Measured: 6 months
Improvement of fecal incontinence
Improvement of fecal incontinence assessed by cleveland clinic florida fecal incontinence score at final follow uo <7
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2025
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel IncontinenceStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelrazak Mohamed Ahmed, Assiut University
- Investigators
- Mahmoud Refaat Shehata, Assistant professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239076
- Sponsor's protocol ID
- Anal sphincteroplasty
- Acronym
- USGMS
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Treat patients with fecal incontinence
Publications
Dexter T, WalshawJ ,Winny H,LeoA
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unstimulated Gluteus Maximus Sphincteroplasty for Treatment of Bowel Incontinence
- ClinicalTrials.gov ID
- NCT07239076
- Acronym / sponsor ID
- USGMS / Anal sphincteroplasty
- Conditions
- Bowel Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 20 Nov 2025 (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.
Unstimlated gluteus maximus sphincteroplasty for treatment of bowle incontinence
Detailed description
Surgery to treat patient with bowel incontinence by using unstimulated gluteus maximus muslce in creating neosphincter by dicussating lower third of muscle with neovascular bundle and suturing on contralateral side ischial tuberosity
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age not below 9 years | Experimental | Procedure: Unstimulated gluteus maximus sphincteroplastySurgery target people not below the age of 9 yearsLower gluteal crease incision and lower third fibers taken with neovascular bundle and suturing on contralateral ischial tuberosity to make external sphincter and make neosphincter |
Who may qualify
- Ages
- 9 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with severe fecal incontinence refractory to medical treatment
- loss of native anal sphincter confirmed by MRI
- patients deemed suitable for unstimulated gluteus maximus sphincteroplasty
Key exclusion criteria (3 listed)
- amyotrophic lateral sclerosis
- severe scarring of bilateral gluteus maximus
- pelvic fracture with injury of internal illiac vessels
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 |
|---|---|---|
| Unstimulated gluteus maximus sphincteroplastySurgery done under general anethesia prone jacknige postion .. incsion made along lower gluteal crease to take lower third fibers including neurovascular bundle and dicussating subcutaneusly around anus and suturing on contralateral ischial tuberosity | Procedure or surgery | Age not below 9 years |
Primary outcome
Improvement of fecal incontinence
Time frame: 6 months
Improvement of fecal incontince assessed by cleveland clinic florida fecal incontinnence score <7
Improvement of fecal incontinence
Time frame: 6 months
Improvement of fecal incontinence assessed by cleveland clinic florida fecal incontinence score at final follow uo <7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publicationDexter T, WalshawJ ,Winny H,LeoA
- Treatment of bowel incontinenceLink provided by the sponsor.
- Treatment of fecal incontinenceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Treat patients with fecal incontinence
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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.
Gamal Abdelhamid Professor dr gamal, Professor doctor contact
Mahmoud Refaat Shehata, Assistant professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unstimulated gluteus maximus sphincteroplasty in people with Bowel Incontinence, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gamal Abdelhamid Professor dr gamal, Professor doctor (01006369722 ext. 01005597112, Eed@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of fecal incontinence (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07239076, which also lists 1 linked publication.
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 20 Nov 2025.