Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00372190
• Collaborator: (none)
• Enrollment: 194
• Locations: 13
• Arms: 2
• Duration (Months): 112
• Patients Per Site: 14.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications.

This study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is to track the complications of both procedures.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Device: Tensionfree vaginal mesh kit (Prolift); Procedure: classic vaginal prolapse surgery (fascia plication)	N/A

Detailed Description

Patients with recurrent prolapse after surgery can participate in this study. A total of 194 women will be included. At random 97 patients undergo a standard prolapse operation and 97 patients undergo an operation with the mesh. Evaluation will take place during surgery, at the postoperative visit after six weeks, and after six months and twelve months. Quality of life, degree of vaginal prolapse, subjective effectiveness, safety and incidence of complications will be evaluated.

An amendment to the original study has been approved by the Ethical Committee to examine long term outcome of this RCT at 7 years. This study was completed in december 2015.

Study Design

• Study Type: Interventional
• Actual Enrollment: 194 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mesh surgery Trocar guided tension free vaginal mesh insertion by Prolift mesh kit	Device: Tensionfree vaginal mesh kit (Prolift); Insertion of a tension free vaginal mesh using a Prolift mesh kit; Other Names: Prolift mesh
Active Comparator: Conventional vaginal surgery Classical vaginal prolapse surgery (fascia plication)	Procedure: classic vaginal prolapse surgery (fascia plication); classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse; Other Names: Conventional

Outcome Measures

Primary Outcome Measures

1. Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months [12 months]

   Number of participants with anatomic failures defined as "Pelvic Organ Prolapse" (POP) stage II or higher

Secondary Outcome Measures

1. Mesh Exposure at 12 Months [12 months]

   cumulative number of patients with mesh exposure at 12 months (if diagnosed at 6 weeks or 6 months and treated, the exposure is calculated at 12 months, even if the exposure was not there anymore)

2. "Patient Global Impression of Improvement" (PGI-I) at 12 Months [at 12 months]

   Number of participants with much to very much improvement compared to baseline

3. Bulge Symptoms [12 months]

   Bulge symptoms defined as Prolapse domain score of the "Urogenital Distress Inventory" (UDI) at 12 months. Scores range from 0 (least/no bother) to 100 (maximum bother)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• recurrent anterior and/or posterior prolapse POP-Q stage 2 or more

• patient has agreed to undergo implantation of TVM (prolift) or fascial plication

• patient is willing to return for follow-up evaluation at 6 weeks, 6 months and 12 months

• patient is willing to complete quality of life questionnaires at 6 and 12 months

Exclusion Criteria:

• patient is or wants to become pregnant

• patient has had previous synthetic mesh procedure (a previous mid-urethral sling procedure is NOT an exclusion criterion)

• patient has current urinary tract or vaginal infections

• patient has a blood coagulation disorder

• patient has a compromised immune system or any other condition that would compromise healing

• patient has renal insufficiency and/or upper urinary tract obstruction

• patient is unwilling or unable to return for evaluation

• patient has had previous irradiation

• patient has any malignancy

• patient has large ovarian cysts of large myoma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gelre ziekenhuizen	Apeldoorn		Netherlands
2	Slysis Zorggroep, location Rijnstate	Arnhem		Netherlands
3	Reinier de Graaf Gasthuis	Delft		Netherlands
4	Medisch Spectrum Twente	Enschede		Netherlands
5	Groene Hart Ziekenhuis	Gouda		Netherlands
6	St. Antonius Ziekenhuis	Nieuwegein		Netherlands
7	UMC St Radboud	Nijmegen		Netherlands
8	Ikazia	Rotterdam		Netherlands
9	Refaja	Stadskanaal		Netherlands
10	St. Elisabeth hospital	Tilburg		Netherlands
11	Twee Steden Ziekenhuis	Tilburg		Netherlands
12	Zaans Medisch Centrum	Zaandam		Netherlands
13	Isala klinieken	Zwolle		Netherlands

Sponsors and Collaborators

• Radboud University Medical Center

Investigators

• Principal Investigator: Mariella ij Withagen, Drs., UMC St Radboud

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mariella Withagen, Principal Investigator, Radboud University Medical Center
• ClinicalTrials.gov Identifier: NCT00372190
• Other Study ID Numbers: P0609
• First Posted: Sep 6, 2006
• Last Update Posted: Jul 3, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Mariella Withagen, Principal Investigator, Radboud University Medical Center: Pelvic organ prolapse; recurrence; mesh; complications; treatment
• Additional relevant MeSH terms: Uterine Prolapse; Prolapse; Pelvic Organ Prolapse

Study Results

Participant Flow

Arm/Group Title	Mesh	Conventional
Arm/Group Description	Insertion of Tensionfree vaginal mesh (Prolift) Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit. 95 randomized for mesh, 2 refused surgery; 93 underwent mesh insertion	Classical vaginal prolapse surgery (fascia plication) classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse 99 randomized to conventional surgery, 1 refused surgery for comorbidity, 1 died prior to surgery; 97 underwent conventional surgery
Period Title: Overall Study
STARTED	93	97
COMPLETED	90	96
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Mesh	Conventional	Total
Arm/Group Description	Insertion of Tensionfree vaginal mesh (Prolift) Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit	Classical vaginal prolapse surgery (fascia plication) classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse	Total of all reporting groups
Overall Participants	93	97	190
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (10.5)	64 (10.2)	64 (10.3)
Sex: Female, Male (Count of Participants)
Female	93 100%	97 100%	190 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months
Description	Number of participants with anatomic failures defined as "Pelvic Organ Prolapse" (POP) stage II or higher
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mesh	Conventional
Arm/Group Description	Insertion of Tensionfree vaginal mesh (Prolift) Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit. 95 randomized for mesh, 2 refused surgery; 93 underwent mesh insertion	Classical vaginal prolapse surgery (fascia plication) classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse 99 randomized to conventional surgery, 1 refused surgery for comorbidity, 1 died prior to surgery; 97 underwent conventional surgery
Measure Participants	83	84
anatomic failures	8 8.6%	38 39.2%
anatomic success	75 80.6%	46 47.4%
no anatomic evaluation	7 7.5%	13 13.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mesh, Conventional
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Mesh Exposure at 12 Months
Description	cumulative number of patients with mesh exposure at 12 months (if diagnosed at 6 weeks or 6 months and treated, the exposure is calculated at 12 months, even if the exposure was not there anymore)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mesh	Conventional
Arm/Group Description	Insertion of Tensionfree vaginal mesh (Prolift) Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit	Classical vaginal prolapse surgery (fascia plication) classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
Measure Participants	93	97
Number [participants]	14 15.1%	0 0%

3. Secondary Outcome

Title	"Patient Global Impression of Improvement" (PGI-I) at 12 Months
Description	Number of participants with much to very much improvement compared to baseline
Time Frame	at 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mesh	Conventional
Arm/Group Description	Insertion of Tensionfree vaginal mesh (Prolift) Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit	Classical vaginal prolapse surgery (fascia plication) classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
Measure Participants	84	88
Number [participants]	54 58.1%	54 55.7%

4. Secondary Outcome

Title	Bulge Symptoms
Description	Bulge symptoms defined as Prolapse domain score of the "Urogenital Distress Inventory" (UDI) at 12 months. Scores range from 0 (least/no bother) to 100 (maximum bother)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mesh	Conventional
Arm/Group Description	Insertion of Tensionfree vaginal mesh (Prolift) Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit	Classical vaginal prolapse surgery (fascia plication) classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
Measure Participants	84	88
Mean (Standard Deviation) [units on a scale]	6 (17)	5 (17)

Adverse Events

Arm/Group Title	Mesh		Conventional
Arm/Group Description	Insertion of Tensionfree vaginal mesh (Prolift) Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit		Classical vaginal prolapse surgery (fascia plication) classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
All Cause Mortality
	Mesh		Conventional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Mesh		Conventional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/93 (8.6%)		2/97 (2.1%)
Renal and urinary disorders
Bladder perforation	2/93 (2.2%)	2	0/97 (0%)	0
Surgical and medical procedures
Repeat surgery for postoperative hematoma	0/93 (0%)	0	1/97 (1%)	1
Hematoma	6/93 (6.5%)	6	1/97 (1%)	1
Other (Not Including Serious) Adverse Events
	Mesh		Conventional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/93 (26.9%)		11/97 (11.3%)
Renal and urinary disorders
de novo SUI	8/81 (9.9%)	8	8/88 (9.1%)	8
Reproductive system and breast disorders
de novo dyspareunia	3/37 (8.1%)	3	3/29 (10.3%)	3
Surgical and medical procedures
Mesh exposure	14/93 (15.1%)	14	0/97 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.