Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

A Prospective,Multicenter Pilot Study to Evaluate the Clinical Performance of the Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01760603
• Other study ID #: pumch-gyn-04
• Status: Recruiting
• Phase: N/A
• First received: December 25, 2012
• Last updated: January 2, 2013
• Start date: December 2012
• Est. completion date: December 2017

Study information

• Verified date: December 2012
• Source: Peking Union Medical College Hospital
• Contact: Lan Zhu
• Phone: 8613911714696
• Email: zhu_julie[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 ≥ 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• ISFF
Ischia spinous fascia fixation surgery was performed on patient with pelvic organ prolapse.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	Foshan Maternal and Child Health Hospital	Foshan	Guangdong
China	Affiliated Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The third Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence/absence of complications (composite score)	The occurrence (in the per-operative phase or within 6 weeks post-op) of at least one of the following: 1) bleeding complications; 2) infectious complications; 3) any wound caused by a surgeon movement: bladder, ureteral, or vascular injuries; 4)medical complications: deep vein thrombosis, pulmonary embolism and etc.Complications will be categorized using the Dindo surgical complication grading scale	Up to 6 weeks	Yes
Other	Change from baseline in PFIQ-7 scores		6 month, 1 year, 2 years and 3 years	No
Other	n subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)		6 months, 1 year, 2 years and 3 years	No
Other	Subject global impression assessed on a 5 point Likert scale		6 months, 1 year, 2 years, 3 years	No
Other	Presence/absence of complications (composite score)	Long-term negative outcomes of the surgical procedure will also be recorded until 3 years after surgery. For example, de novo urinary incontinence, de novo dyspareunia and overall failure rate. Complications will be categorized using the Dindo surgical complication grading scale.	up to 3 years	Yes
Primary	Anatomical improvement according to POP-Q Score		6 weeks	No
Primary	Anatomical improvement according to POP-Q Score		1 year	No
Primary	Anatomical improvement according to POP-Q Score		2 years	No
Primary	Anatomical improvement according to POP-Q Score		3 years	No
Secondary	Hospital data including operative time, estimated blood loss, length of stay, postoperative mortality, time of voiding recovery		At discharge, an expected average of 5 days after operation	Yes