Trial Outcomes & Findings for Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse. (NCT NCT00372190)

NCT ID: NCT00372190

Last Updated: 2017-07-03

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 194 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2017-07-03

Participant Flow

Participant milestones

Measure	Mesh 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	Conventional 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
Overall Study STARTED	93	97
Overall Study COMPLETED	90	96
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Mesh 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	Conventional 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
Overall Study Lost to Follow-up	3	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Mesh n=93 Participants Insertion of Tensionfree vaginal mesh (Prolift) Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit	Conventional n=97 Participants Classical vaginal prolapse surgery (fascia plication) classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse	Total n=190 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 10.5 • n=5 Participants	64 years STANDARD_DEVIATION 10.2 • n=7 Participants	64 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	97 Participants n=7 Participants	190 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	Mesh n=83 Participants 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	Conventional n=84 Participants 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
Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months anatomic failures	8 participants	38 participants
Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months anatomic success	75 participants	46 participants
Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months no anatomic evaluation	7 participants	13 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Mesh n=93 Participants 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	Conventional n=97 Participants 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
Mesh Exposure at 12 Months	14 participants	0 participants

SECONDARY outcome

Timeframe: at 12 months

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

Outcome measures

Measure	Mesh n=84 Participants 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	Conventional n=88 Participants 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
"Patient Global Impression of Improvement" (PGI-I) at 12 Months	54 participants	54 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Mesh n=84 Participants 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	Conventional n=88 Participants 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
Bulge Symptoms	6 units on a scale Standard Deviation 17	5 units on a scale Standard Deviation 17

Adverse Events

Mesh

Serious events: 8 serious events

Other events: 25 other events

Deaths: 0 deaths

Conventional

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mesh n=93 participants at risk Insertion of Tensionfree vaginal mesh (Prolift) Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit	Conventional n=97 participants at risk Classical vaginal prolapse surgery (fascia plication) classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
Renal and urinary disorders Bladder perforation	2.2% 2/93 • Number of events 2	0.00% 0/97
Surgical and medical procedures Repeat surgery for postoperative hematoma	0.00% 0/93	1.0% 1/97 • Number of events 1
Surgical and medical procedures Hematoma	6.5% 6/93 • Number of events 6	1.0% 1/97 • Number of events 1

Other adverse events

Measure	Mesh n=93 participants at risk Insertion of Tensionfree vaginal mesh (Prolift) Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit	Conventional n=97 participants at risk Classical vaginal prolapse surgery (fascia plication) classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
Surgical and medical procedures Mesh exposure	15.1% 14/93 • Number of events 14	0.00% 0/97
Reproductive system and breast disorders de novo dyspareunia	8.1% 3/37 • Number of events 3	10.3% 3/29 • Number of events 3
Renal and urinary disorders de novo SUI	9.9% 8/81 • Number of events 8	9.1% 8/88 • Number of events 8

Additional Information

Dr. M.I.J.Withagen

Radboud University Medical Center

Phone: +31 6 51262468

Email: M.I.J.Withagen@umcutrecht.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place