Pelvic Organ Prolapse Clinical Trial
Official title:
Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy. A Pilot One Arm Clinical Trial
The goal of this clinical trial is to test the benefit of using gamma-irradiated amniotic membrane as a graft in surgical repair for women with posterior vaginal wall defects. The main question it aims to answer is: • Is posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft effective? Participants will undergo posterior colporrhaphy, which will be modified by adding gamma-irradiated amniotic membrane as a graft during the repair.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | March 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 60 Years |
Eligibility | Inclusion Criteria: - Women diagnosed as posterior vaginal wall prolapse: bulging of front wall of rectum into the vagina due to weakening of pelvic support system and thinning of rectovaginal septum. - Women aged 30-60 years. - BMI 20-35 kg/m2 - Planned for surgical correction Exclusion Criteria: - Patients with: - Immuno-compromise e.g. Patients receiving chemotherapy, steroids. - Severe anaemia (Hb<10) - conditions that require concomitant reconstructive pelvic floor surgery e.g., anterior and/or apical compartment prolapse. - Conditions that lead to increase intra-abdominal pressure e.g.,chronic obstructive pulmonary disease. - Uncontrolled medical disorders (diabetes, hypertension, asthma). |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams Maternity Hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams Maternity Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | POP-Q | Prolapse assessment using the prolapse quantification system of the International Continence Society (POP-Q) | first week postoperative | |
Primary | POPDI-6 score | Assessment of symptoms score using Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6) part of the Pelvic Floor Distress Inventory Short Form 20. Scale from 0 to 100, the higher score indicates worse condition. | at 3 months, and at 6 months postoperative | |
Secondary | sexual satisfaction | to measure sexual satisfaction using female sexual function index questionnaire The Female Sexual Function Index (FSFI) was developed to assess six domains of female sexual function (sexual desire, sexual arousal, lubrication, orgasm, satisfaction, and pain).
Items are scored on a five-point Likert scale with low scores indicating lower levels of sexual functioning. Fifteen items also include a zero score as a sixth response option indicating no sexual activity in the past 4 weeks. Range: 2 to 36. |
at 3 months, and at 6 months postoperative | |
Secondary | wound complications | Wound infection or wound dehiscence as detected clinically and /or CRP and vaginal swab as needed | within 6 months postoperative | |
Secondary | Intraoperative complications | occurrence of intraoperative bladder or bowel injury | Intraoperative |
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