GYNECARE PROSIMA* Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Uterine Prolapse Stage III

NCT01396109 | Unknown

• 1 other identifier: pumch-gyn-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

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, sometimes a mesh is placed in the pelvis to support the weakened tissues, but mesh implants can cause complications. This study is designed to determine the effectiveness and safety of GYNECARE PROSIMA\* pelvic floor repair system compared with the modified total pelvic floor reconstructive surgery with mesh for the treatment of uterine prolapse. 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; Stage III

Outcome Measures

Primary Outcomes (5)

• Anatomical improvement according to POP-Q score.

  4 weeks

• Anatomical improvement according to POP-Q score.

  6 months

• Anatomical improvement according to POP-Q score.

  12 months

• Anatomical improvement according to POP-Q score.

  2 years

• Anatomical improvement according to POP-Q score.

  3 years

Secondary Outcomes (7)

• Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery.

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

• Pain score measured using Visual Analog Scale (VAS).

  24 hours post surgery and at the 3-4 week visit

• Presence/absence of complications (composite score).

  Up to 6 weeks.

• Change from baseline in PFIQ-7 scores.

  6 months, 12 months, 2 years and 3 years.

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

  6 months, 12 months, 2 years and 3 years.

Study Arms (2)

Group I

ACTIVE COMPARATOR

Intervention: Procedure: TVH and GYNECARE PROSIMA\* Pelvic Floor Repair System

Procedure: Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System

Group II

ACTIVE COMPARATOR

Intervention: Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with Mesh

Procedure: Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh

Interventions

Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System PROCEDURE

Subjects of this group were submitted to surgical treatment with GYNECARE PROSIMA\* Pelvic Floor Repair System concurrently with transvaginal hysterectomy.

Group I

Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh PROCEDURE

Subjects of this group were submitted to surgical treatment of Modified Pelvic Floor Reconstruction Surgery with mesh concurrently with transvaginal hysterectomy.

Group II

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidates with symptomatic uterine prolapse of ICS POP-Q Stage III(with any degree of vaginal prolapse), suitable for surgical repair.
• Vaginal hysterectomy will be performed concurrently.
• Without stress urinary incontinence or occult stress urinary incontinence with no need of mid-urethral sling procedures for incontinence to be performed.
• Age ≥ 60 years.
• Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent.

You may not qualify if:

• Additional surgical intervention concurrent to the procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).
• 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 (10)

Hefei Maternity and Child Health Hospital

Hefei, Anhui, 230001, China

ACTIVE NOT RECRUITING

Gansu Maternity and Child Health Hospital

Lanzhou, Gansu, 730050, China

RECRUITING

Hebei Provincial Hospital

Shijiazhuang, Hebei, 050051, China

ACTIVE NOT RECRUITING

the First Affliliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Wuxi Maternal and Child Health Hospital, Nanjing Medical University

Wuxi, Jiangsu, 214002, China

RECRUITING

Maternal and Child Health Hospital of Jiangxi Province

Nanchang, Jiangxi, 330006, China

ACTIVE NOT RECRUITING

Laizhou Municipal People's Hospital

Laizhou, Shandong, 261400, China

RECRUITING

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

RECRUITING

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Uterine Prolapse

Interventions

Melanocyte-Stimulating Hormones

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

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Lan Zhu

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lan Zhu

CONTACT

86-10-65296238; zhu_julie@vip.sina.com

Juan Chen

CONTACT

86-13521354364; pumchcj@sina.com

Study Design

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

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 18, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 27, 2012

Record last verified: 2011-03

Locations

CN (10)