Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study

Pelvic Organ Prolapse Clinical Trial

Official title:

Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938881
• Other study ID #: extended TVM
• Status: Recruiting
• Start date: June 29, 2023
• Est. completion date: March 12, 2033

Study information

• Verified date: July 2023
• Source: Peking Union Medical College Hospital
• Contact: Lan Zhu
• Phone: 86-10-69155749
• Email: zhu_julie[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The original RCT trial is designed to compare self-tailored titanium-coated polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of efficacy, safety and cost-effective at 1-year follow-up. This study will follow women in the original RCT study for up to 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in previous RCT, no new treatment interventions will be given. Recruitment into the previous RCT is closed. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.

Description:

The previous study is a randomized trial designed to compare the composite success rate between patients with self-cut mesh procedure and those with mesh-kit procedure. The original RCT study includes a 1-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures. The goal of this long-term follow-up study is to extend the follow-up of women in the previous RCT study up to 10 years from the time of surgery and to compare the success and complication rates of the two surgical treatment groups over this extended time period.

The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 10 years. A supplemental study investigates the long-term success rate and complications of transvaginal mesh procedure in women in both of the study arms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: March 12, 2033
• Est. primary completion date: January 12, 2033
• Gender: Female
• Age group: 53 Years to 75 Years

Eligibility

Inclusion Criteria:

• Women enrolled in previous RCT study

Exclusion Criteria:

• Inability to provide informed consent. Informed consent will be obtained prior to each telephone interview and each in-person visit.

• Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• self-cut mesh procedure
transvaginal mesh procedure using self-cut mesh
• mesh-kit procedure
transvaginal mesh procedure using mesh-kit

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	Changsha Maternal and Child Health Care Hospital	Changsha	Hunan
China	The Secong Xiangya Hospital of Central South University	Changsha	Hunan
China	Sichuan University West China Second University Hospital	Chengdu	Sichuan
China	Foshan Maternal and Child Health Care Hospital	Foshan	Guangdong
China	The First Affiliated Hospital of Guangdong Medical College	Guangzhou	Guangdong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	the First Affiliated Hosptial of Xinjiang Medical University	Ürümqi	Xiangjiang
China	The People's Hospital of Xinjiang Uygur Autonomous Region	Ürümqi	Xinjiang
China	Wuxi Maternal and Child Health Care Hospital	Wuxi	Jiangsu
China	Shanxi Provincial People's Hosptial	Xi'an	Shanxi

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
Primary	Composite success	To determine the long-term (up to 10 years) composite success rate of both procedure (defined as leading edge above the hymen (i.e Ba, C, Bp<0 cm) AND deny vaginal bulging symptoms indicated by a negative response question 3 of the pelvic floor distress inventory- 20 (PFDI-20): "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? AND no re-operation or pessary treatment for POP), and whether composite success rate differs between women who had self-cut mesh procedure vs. those who had mesh-kit procedure; This outcome measure is cumulative across the original RCT trial and continued through the extended trial follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)	up to 10 years after procedure
Secondary	anatomic outcomes	Anatomic failure was defined as POPQ system leading edge at or beyond the hymen (i.e Ba, C, Bp=0 cm). This outcome measure is cumulative across the original RCT trial and continued through the extended follow-up study with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)	up to 10 years after operation
Secondary	Change From Baseline PFIQ-7 Score	The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year [up to 10 years] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.	up to 10 years after operation
Secondary	Change From Baseline PFDI-20 Score	The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (Year [up to 10 years] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.	up to 10 years after operation
Secondary	Change From Baseline PISQ-12 Score	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, (PISQ-12) is a questionnaire measuring the impact of POP symptoms on sexual function and satisfaction. The PISQ-12 Score ranges from 0 to 48 with higher scores indicating better function/satisfaction. Change = (Year [up to 10 years] Score - Baseline Score). Higher scores indicate better function / fewer symptoms.	up to 10 years after operation
Secondary	Symptomatic improvement using patient global impression of change (PGI-C)	The Patient Global Impression of Change (PGI-C) is a patient-reported measure of perceived change with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).	up to 10 years after operation
Secondary	Complications	Using IUGA/ICS Joint Terminology CTS coding system and Clavien-Dindo classification	up to 10 years after operation