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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05938881

Collaborator

(none)

336

Enrollment

Locations

116.4

Anticipated Duration (Months)

30.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: self-cut mesh procedure Procedure: mesh-kit procedure

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

336 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 29, 2023

Anticipated Primary Completion Date :

Jan 12, 2033

Anticipated Study Completion Date :

Mar 12, 2033

Arms and Interventions

Arm	Intervention/Treatment
self-cut mesh procedure This procedure is transvaginal mesh implantation surgery for POP patients. Self-cut mesh procedure is an economic pelvic reconstructive surgical operation with use of specially designed puncture needles and self-cut mesh, which mainly provide anterior and apical compartments support, with posterior compartment reinforced by bridge technique repair. The mesh pieces used in this surgery was cut from a single piece of mesh material(TiLOOP 10*15cm) which is much cheaper and readily available. Patients could have transvaginal hysterectomy concomitantly.	Procedure: self-cut mesh procedure transvaginal mesh procedure using self-cut mesh
mesh-kit procedure This procedure is transvaginal mesh implantation surgery for POP patients.Mesh-kit procedure is refered to pelvic floor reconstructive surgery with titanium-coated meshes kit(TiLOOP TOTAL6).Patients could have transvaginal hysterectomy concomitantly.	Procedure: mesh-kit procedure transvaginal mesh procedure using mesh-kit

Arm

Intervention/Treatment

self-cut mesh procedure

This procedure is transvaginal mesh implantation surgery for POP patients. Self-cut mesh procedure is an economic pelvic reconstructive surgical operation with use of specially designed puncture needles and self-cut mesh, which mainly provide anterior and apical compartments support, with posterior compartment reinforced by bridge technique repair. The mesh pieces used in this surgery was cut from a single piece of mesh material(TiLOOP 10*15cm) which is much cheaper and readily available. Patients could have transvaginal hysterectomy concomitantly.

Procedure: self-cut mesh procedure

transvaginal mesh procedure using self-cut mesh

mesh-kit procedure

This procedure is transvaginal mesh implantation surgery for POP patients.Mesh-kit procedure is refered to pelvic floor reconstructive surgery with titanium-coated meshes kit(TiLOOP TOTAL6).Patients could have transvaginal hysterectomy concomitantly.

Procedure: mesh-kit procedure

transvaginal mesh procedure using mesh-kit

Outcome Measures

Primary Outcome Measures

Composite success [up to 10 years after procedure]
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.)

Secondary Outcome Measures

anatomic outcomes [up to 10 years after operation]
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.)
Change From Baseline PFIQ-7 Score [up to 10 years after operation]
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.
Change From Baseline PFDI-20 Score [up to 10 years after operation]
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.
Change From Baseline PISQ-12 Score [up to 10 years after operation]
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.
Symptomatic improvement using patient global impression of change (PGI-C) [up to 10 years after operation]
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).
Complications [up to 10 years after operation]
Using IUGA/ICS Joint Terminology CTS coding system and Clavien-Dindo classification

Eligibility Criteria

Criteria

Ages Eligible for Study:

53 Years to 75 Years

Sexes Eligible for Study:

Female

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.

Contacts and Locations

Locations

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