A Phase 4 interventional study of Transvaginal repair & botulinum toxin type A injection and Transvaginal repair & distilled water injection in Obstructed Defaecation Syndrome and Anterior Rectocele, sponsored by Mansoura University. Active, not recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Mansoura University · Phase 4, Interventional, and Treatment
This is a single-centre, prospective randomized controlled trial on female patients with anterior rectocele associated with obstructed defecation syndrome
50 studies on the registry are indexed under Rectocele; 9 are open to participants now.
This study's planned enrollment of 60 is close to the median of 62 across 37 interventional studies indexed under Rectocele.
Browse Rectocele studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: all required
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Transvaginal repair & botulinum toxin type A injection
Procedure: Transvaginal repair & distilled water injection
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)
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)
Recurrence rate
Time frame: One year
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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