NCT01760603

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 4, 2013

Status Verified

December 1, 2012

Enrollment Period

2 years

First QC Date

December 25, 2012

Last Update Submit

January 2, 2013

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse

Outcome Measures

Primary Outcomes (4)

  • Anatomical improvement according to POP-Q Score

    6 weeks

  • Anatomical improvement according to POP-Q Score

    1 year

  • Anatomical improvement according to POP-Q Score

    2 years

  • Anatomical improvement according to POP-Q Score

    3 years

Secondary Outcomes (1)

  • 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

Other Outcomes (5)

  • Presence/absence of complications (composite score)

    Up to 6 weeks

  • Change from baseline in PFIQ-7 scores

    6 month, 1 year, 2 years and 3 years

  • 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

  • +2 more other outcomes

Study Arms (1)

ISFF

EXPERIMENTAL

The patients performed ischia spinous fascia fixation surgery.

Procedure: ISFF

Interventions

ISFFPROCEDURE

Ischia spinous fascia fixation surgery was performed on patient with pelvic organ prolapse.

ISFF

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Foshan Maternal and Child Health Hospital

Foshan, Guangdong, 528000, China

RECRUITING

The third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Affiliated Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Lan Zhu

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lan Zhu

CONTACT

8613911714696zhu_julie@sina.com

Juan Chen

CONTACT

8613521354364pumchcj@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2012

First Posted

January 4, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2017

Last Updated

January 4, 2013

Record last verified: 2012-12

Locations

CN(4)