Clinical trial NCT01760603: Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse
Official title: A Prospective,Multicenter Pilot Study to Evaluate the Clinical Performance of the Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure is developed in China for vaginal apex fixation with native tissue.

This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure for the treatment of pelvic organ prolapse stage III.

Patients enrolled into the study will be followed up for up to 3 years after surgery. Evaluation will take place during surgery and postoperative visit. Stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates will be evaluated.

Detailed description: Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. An ideal procedure for vaginal apical support should provide a durable suspension, have minimal complications, and not affect sexual or visceral function.

Ischia spinous fascia fixation procedure is developed in China. It is a transvaginal procedure used for restoring the vaginal apex support with native tissue. Clinical practice showed that it was safe, efficient and cost-effective. Recurrent rate after 1 year follow-up was about 10%, and quality of life improved significantly from the baseline.

The purpose of this multicenter, prospective study is to evaluate the effectiveness and safety of this procedure in the treatment of symptomatic pelvic organ prolapse.

Eligibility criteria: Inclusion Criteria:

* Candidates with symptomatic pelvic organ prolapse of POP-Q Stage II or more, suitable for surgical repair.
* Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently.
* Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.

Exclusion Criteria:

* Previous repair of pelvic organ prolapse involving insertion of mesh.
* Experimental drug or experimental medical device within 3 months prior to the planned procedure.
* Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
* Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
* History of chemotherapy or pelvic radiation therapy.
* Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spinal cord injury or trauma).
* Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
* Nursing or pregnant or intends future pregnancy.
* Chronic cough not well-controlled.
* BMI \&#8805; 30.
* In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.

Primary outcomes:
measure: Anatomical improvement according to POP-Q Score
timeFrame: 6 weeks
measure: Anatomical improvement according to POP-Q Score
timeFrame: 1 year
measure: Anatomical improvement according to POP-Q Score
timeFrame: 2 years
measure: Anatomical improvement according to POP-Q Score
timeFrame: 3 years
Secondary outcomes:
measure: Hospital data including operative time, estimated blood loss, length of stay, postoperative mortality, time of voiding recovery
timeFrame: At discharge, an expected average of 5 days after operation
Other outcomes:
measure: Presence/absence of complications (composite score)
timeFrame: Up to 6 weeks
measure: Change from baseline in PFIQ-7 scores
timeFrame: 6 month, 1 year, 2 years and 3 years
measure: n subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)
timeFrame: 6 months, 1 year, 2 years and 3 years
measure: Subject global impression assessed on a 5 point Likert scale
timeFrame: 6 months, 1 year, 2 years, 3 years
measure: Presence/absence of complications (composite score)
timeFrame: up to 3 years
Locations:
city: Foshan
country: China
facility: Foshan Maternal and Child Health Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: The third Affiliated Hospital of Zhengzhou University
state: Henan
city: Shenyang
country: China
facility: Affiliated Shengjing Hospital of China Medical University
state: Liaoning
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lan Zhu
role: PRINCIPAL_INVESTIGATOR
References: