Obstructed Defaecation SyndromePhase 4NCT06804993
Rectocele Repair with or Without Internal Sphincter Botulinum Toxin Injection: a Prospective Randomized Trial
A Phase 4 study testing Transvaginal repair & botulinum toxin type A injection and Transvaginal repair & distilled water injection in people with Obstructed Defaecation Syndrome and Anterior Rectocele, run by Mansoura University at 1 site in Egypt.
Trial summary
This is a single-centre, prospective randomized controlled trial on female patients with anterior rectocele associated with obstructed defecation syndrome Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obstructed Defaecation Syndrome, Anterior Rectocele
- What is being tested?
- Transvaginal repair & botulinum toxin type A injection and Transvaginal repair & distilled water injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jul 2021to 31 Mar 2025
- Phase
- Phase 4
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients
- symptomatic rectocele
- failed conservative treatments for at least 3 months
- anterior rectocele larger than 3 cm in size in defecogram.
- retention of the contrast in the rectocele on defecography
- obstructed defecation manifestations: excessive straining, a sense of incomplete evacuation, the need for digital manipulation during defecation, or dyspareunia
Who cannot join
- significant urinary manifestations due to anterior vaginal wall prolapse
- recurrent rectocele
- previous anal surgery
- slow-transit constipation
- faecal incontinence (FI)
- abnormal thyroid functions
Show all 9Show fewer
- patients under systemic steroid treatment
- patients with connective tissue disease
- ASA classification >3
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-centre, prospective randomized controlled trial on female patients with anterior rectocele associated with obstructed defecation syndrome
- Being tested
- Transvaginal repair & botulinum toxin type A injection, Transvaginal repair & distilled water injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal repair & botulinum toxin type A injectionDrug
100 units of lyophilized botulinum toxin type A were diluted in saline to 50 U/mL before the injections. A total of 30 units of type-A botulinum toxin was injected with a 22-G needle evenly divided in 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock)
Transvaginal repair & distilled water injectionProcedure or surgery
A total of 30 units of distilled water was injected with a 22-G needle evenly divided into 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock)
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal repair & botulinum toxin type A toxin injection | Experimental | Not described Receives: Drug: Transvaginal repair & botulinum toxin type A injection |
| Transvaginal repair & distilled water injection | Placebo comparator | Not described Receives: Procedure: Transvaginal repair & distilled water injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start31 Jul 2021
- Primary completion30 Sep 2023
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructed Defaecation SyndromeStudies of the same condition, open and under way.
- More trials run by Mansoura 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa shalaby, MD, MSc, PhD, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804993
- Sponsor's protocol ID
- MD.21.03.441
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectocele Repair with or Without Internal Sphincter Botulinum Toxin Injection: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06804993
- Acronym / sponsor ID
- MD.21.03.441
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 31 Jul 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 3 Feb 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.
This is a single-centre, prospective randomized controlled trial on female patients with anterior rectocele associated with obstructed defecation syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal repair & botulinum toxin type A toxin injection | Experimental | Drug: Transvaginal repair & botulinum toxin type A injection |
| Transvaginal repair & distilled water injection | Placebo comparator | Procedure: Transvaginal repair & distilled water injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- female patients
- symptomatic rectocele
- failed conservative treatments for at least 3 months
- anterior rectocele larger than 3 cm in size in defecogram.
- retention of the contrast in the rectocele on defecography
Key exclusion criteria (9 listed)
- significant urinary manifestations due to anterior vaginal wall prolapse
- recurrent rectocele
- previous anal surgery
- slow-transit constipation
- faecal incontinence (FI)
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 |
|---|---|---|
| Transvaginal repair & botulinum toxin type A injection100 units of lyophilized botulinum toxin type A were diluted in saline to 50 U/mL before the injections. A total of 30 units of type-A botulinum toxin was injected with a 22-G needle evenly divided in 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock) | Drug | Transvaginal repair & botulinum toxin type A toxin injection |
| Transvaginal repair & distilled water injectionA total of 30 units of distilled water was injected with a 22-G needle evenly divided into 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock) | Procedure or surgery | Transvaginal repair & distilled water injection |
Primary outcome
Recurrence rate
Time frame: One year
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 3 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Obstructed Defaecation Syndrome
Not yet recruiting
Clinical Evaluation of the Femiset Device for Perineal Descent in Women
Perineal Descent, Obstructed Defecation Syndrome (ODS)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transvaginal repair & botulinum toxin type A injection and Transvaginal repair & distilled water injection in people with Obstructed Defaecation Syndrome and Anterior Rectocele, run by Mansoura 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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: One year). 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 3 Feb 2025.