Laparoscopic Sacral Colpopexy Versus Modified Total Pelvic Floor Reconstructive Surgery for Apical Prolapse Stage III-IV

NCT01762384 | Unknown

• 1 other identifier: pumch-gyn-05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

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. The primary treatment is surgery. Sacral Colpopexy is the gold standard procedure. Now it could be done laparoscopically. Modified total pelvic floor reconstructive surgery with mesh is developed in China for Asian Women. This study is designed to determine the effectiveness and safety of Modified total pelvic floor reconstructive surgery with mesh compared with laparoscopic Sacral Colpopexy for the treatment of uterine or vault prolapse Stage III-IV. 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.

Conditions

Uterine Prolapse; Vault Prolapse

Outcome Measures

Primary Outcomes (4)

• anatomical improvement according to POP-Q score

  6 months

• 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 (11)

• Hospital data:operative time

  At discharge, an expected average of 5 days after operation.

• Presence/absence of complications (composite score).

  up to 6 weeks

• Change from baseline in PFIQ-7 scores.

  6 months, 1 year, 2 year, 3 year

• Change from baseline in PFDI-21 scores.

  6 months, 1 year, 2 year, 3 year

• In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)

  6 months, 1 year, 2 year, 3 year

Study Arms (2)

LSC

ACTIVE COMPARATOR

procedure: laparoscopic sacral colpopexy.

Procedure: LSC; Device: "Gynemesh"

Modified PFRS

ACTIVE COMPARATOR

procedure: modified pelvic floor reconstructive surgery with mesh.

Procedure: modified PFRS; Device: "Gynemesh"

Interventions

LSC PROCEDURE

subjects of this group are submitted to surgical treatment of laparoscopic sacral colpopexy.

LSC

modified PFRS PROCEDURE

subjects of this group are submitted to modified pelvic floor reconstructive surgery with mesh.

Modified PFRS

"Gynemesh" DEVICE

Both surgeries will be conducted using mesh constructed from polypropylene mesh.

LSC; Modified PFRS

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidates with symptomatic uterine or vault prolapse of Stage III-IV, suitable for surgical repair.
• Age from 55-65 years old.
• Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.

You may not qualify if:

• Patients who could not tolerate laparoscopic surgery.
• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (4)

The First Affiliated Hospital of Guangzhou Medical College

Ghuangzhou, Guangdong, 510120, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

RECRUITING

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lan Zhu

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lan Zhu

CONTACT

86-13911714696; zhu_julie@sina.com

Juan Chen

CONTACT

86-13521354364; pumchcj@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2012
• First Posted: January 7, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2017
• Last Updated: January 7, 2013

Record last verified: 2012-12

Locations

CN (4)