Clinical trial NCT03772691: Lateral Suspension and Sacropexy for Pelvic Organ Prolapse
Official title: Lateral Suspension Versus Sacropexy for Treatment of Apical Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pelvic organ prolapse (POP) is considered one of the commonest gynecologic health problems all over the world. Pelvic organ prolapse (POP) is common and can be seen in up to 50% or more of parous women. The annual aggregated rate of associated surgery for pelvic organ prolapse is in the range of 10-30 per 10,000 women. It is estimated that women have an 11-19% life-time risk of undergoing surgery for POP. This rate is projected to increase over the next 2-3 decades. Apical POP refers any descent of the cervix or the vaginal cuff scar(as after hysterectomy) below a point which is 2 cm less than the total vaginal length about the plane of the hymen. Apical POP is due to defect in apical support with damage to the cardinal and uterosacral ligaments. Apical pelvic organ prolapse is a common issue in our country with significant incidence rate due to many predisposing factors including increasing age, higher gravidity and parity (especially the number of vaginal births)

Detailed description: By one estimate, the demand for health care services related to pelvic floor disorders will increase at twice the rate of the population itself . So we need adequate understanding of the best surgical method for treating apical POP which is accepted worldwide and also must be cost effective with least perioperative complications. Abdominal sacropexy is considered now the gold standard operation for treatment of apical pelvic organ prolapse. In this technique, the mesh is ﬁxed to the anterior longitudinal ligament at the sacral promontory. It is used either with uterine preservation (sacrohysteropexy) or after hysterectomy (sacrocolpopexy) for treatment of vault prolapse .However , many intraoperative complication can occur including hemorrhage or transfusion or both occurred in 4.4% , intestinal injury or rectal injury in 1.6% (0.4% to 2.5%),and ureteral injury in 1.0% of cases. Postoperative complications include paralytic ileus in 3.6%.transient femoral nerve injury and vertebral osteomyelitis . Also, despite that sacropexy provide good apical support, but the high prevalence of cystocele and urinary tract symptoms in patients reaches up to 8% . Consequently, it is not surprising that the majority of failures following sacrocolpopexy occur in the anterior compartment. Lateral suspension with mesh was ﬁrst reported by Dubuisson in 1998 for the treatment of pelvic organ prolapse . The lateral suspension avoids both the risk of vascular injury and nerve damage of sacrocolpopexy with success rate up to 88% of cases.

Eligibility criteria: Inclusion Criteria:

* Apical prolapse Stage 2-4 according to POP-Q system
* Uterine preservation or after hysterectomy
* Sexually active or not.

Exclusion Criteria:

* Pregnancy or up to 6 months postpartum.
* Current Urinary tract infection proved by urine analysis or urine culture.
* Patient unfit for surgery.
* Previous suspension operations.
* Uncontrolled diabetic patients.
* Urge incontinence.

Primary outcomes:
measure: rate of occurance of denovo stress urinary incontinence
timeFrame: 18 months
measure: The rate of Improvement of urinary symptoms
timeFrame: 18 months
Secondary outcomes:
measure: objective assessment of prolapse stage
timeFrame: 18 months
measure: assessment of sexual function
timeFrame: 18 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References: