Urinary Incontinence, StressNCT01725984

AMS AdVance and AdVance XP Male Sling Systems for the Treatment of Stress Urinary Incontinence Following Prostatectomy: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review and Prospective Follow-up

An observational study of Urinary Incontinence, Stress and Intrinsic Sphincter Deficiency, run by American Medical Systems at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A single-center retrospective chart review of AdVance and AdVance XP subject data, combined with prospective follow-up of the same subjects to confirm continence, adverse event, and quality of life status. This study includes patients previously implanted with an AdVance or AdVance XP male sling. Read more about this study

Who is it for?: Ages 40 years and older, men only
Conditions the study is for: Urinary Incontinence, Stress, Intrinsic Sphincter Deficiency
How many people: 80 participants
Where: 1 siteGermany
Study dates: Aug 2012to Jan 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
Men only
No healthy volunteers
Adult, Older adult

Study population: Male subject ≥40 years of age who received the AdVance male sling after January 1, 2010 or the AdVance XP male sling after July 1, 2010 for the treatment of post prostatectomy SUI at one institution in Munich, Germany.

Who may be able to join

Valid, written informed consent has been obtained
Male subject ≥40 years of age who received the AdVance male sling after January 1, 2010 or the AdVance XP male sling after July 1, 2010 for the treatment of post prostatectomy SUI
Pad use of 1 to 8 pads per day prior to sling placement (subjects who used only a dry prophylactic pad or safety liner at baseline will not be included)
External (distal) sphincter contractility and a coaptive zone of ≥ 1cm confirmed by endoscopic view prior to sling placement
Primary etiology of SUI resulting from radical prostatectomy including, simple open prostatectomy, robotic or laparoscopic prostatectomy

Who cannot join

Pad use of more than 8 pads per day prior to sling placement for incontinence management
Urine loss while lying in bed prior to sling placement
Treatment with a urethral sling system, an AMS Sphincter 800®, or any implanted device for the treatment of urinary incontinence (not including bulking agents) prior to sling placement
TURP procedure prior to sling placement
Urge predominant incontinence prior to sling placement
Past or current neurological disorder (e.g. neurogenic bladder, multiple sclerosis, Parkinson's disease)

Show all 10Show fewer

History of connective tissue or autoimmune conditions
Past or current condition of compromised immune system
Placement of an inflatable penile prosthesis (IPP) after sling placement
Post void residual of >50 ml prior to sling placement

Trial locations and contacts

1 site in 1 country.

Germany1 site

Ludwig-Maximilians Universität (LMU)
Munich, Bavaria, 81377

Other trials in Germany

About this study

Read the detailed description

Conditions: Urinary Incontinence, Stress, Intrinsic Sphincter Deficiency
Keywords: Male Incontinence, AdVance Male Sling, AdVance XP Male Sling, Male Sling
Medical subject headings: Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01725984
Study group	Role	What they receive
AdVance		Subjects previously implanted with the AdVance Male Sling
AdVance XP		Subjects previously implanted with the AdVance XP male sling

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use
Evaluate the proportion of subjects with a ≥50% reduction in pads per day use
Measured: 3 Months Post Procedure
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use
Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit
Measured: 3 months Post Procedure
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);
Measured: Baseline
Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit
Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.
Measured: Prospective follow-up to 36 Months Post Procedure
Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow.
The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100.
The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 1-21.
The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7.
Measured: Baseline to Prospective Follow Up (up to 36 months)
Number of Adverse Events Reported Between Arms
Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events
Measured: Prospective follow-up to 36 Months Post Procedure
Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use
Evaluate the proportion of subjects with a ≥50% reduction in pads per day use
Measured: Prospective follow-up to 36 Months Post Procedure
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use
Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit
Measured: Prospective follow-up to 36 Months Post Procedure
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);
Measured: 3 Months Post Procedure
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);
Measured: Prospective follow-up to 36 Months Post Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Jan 2014

First posted14 Nov 2012 (estimated)
Study startAug 2012
Primary completionJan 2013
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01725984
Sponsor's protocol ID: MC1201
Status last verified: Jun 2015
First submitted: 13 Jul 2012
Last updated: 30 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Urinary Incontinence, Stress trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AMS AdVance and AdVance XP Male Sling Systems for the Treatment of Stress Urinary Incontinence Following Prostatectomy: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review and Prospective Follow-up
ClinicalTrials.gov ID: NCT01725984
Acronym / sponsor ID: MC1201
Conditions: Urinary Incontinence, Stress, Intrinsic Sphincter Deficiency
Keywords: Male Incontinence, AdVance Male Sling, AdVance XP Male Sling, Male Sling
Study type: Observational
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: American Medical SystemsIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2014 (actual)
First posted: 14 Nov 2012 (estimated)
Results: Posted 30 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Number of arms: 2

Arm	Type	Receives
AdVance	–	–Subjects previously implanted with the AdVance Male Sling
AdVance XP	–	–Subjects previously implanted with the AdVance XP male sling

Who may qualify

Ages: 40 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Male subject ≥40 years of age who received the AdVance male sling after January 1, 2010 or the AdVance XP male sling after July 1, 2010 for the treatment of post prostatectomy SUI at one institution in Munich, Germany.

Key inclusion criteria (5 listed)

Valid, written informed consent has been obtained
Male subject ≥40 years of age who received the AdVance male sling after January 1, 2010 or the AdVance XP male sling after July 1, 2010 for the treatment of post prostatectomy SUI
Pad use of 1 to 8 pads per day prior to sling placement (subjects who used only a dry prophylactic pad or safety liner at baseline will not be included)
External (distal) sphincter contractility and a coaptive zone of ≥ 1cm confirmed by endoscopic view prior to sling placement
Primary etiology of SUI resulting from radical prostatectomy including, simple open prostatectomy, robotic or laparoscopic prostatectomy

Key exclusion criteria (10 listed)

Pad use of more than 8 pads per day prior to sling placement for incontinence management
Urine loss while lying in bed prior to sling placement
Treatment with a urethral sling system, an AMS Sphincter 800®, or any implanted device for the treatment of urinary incontinence (not including bulking agents) prior to sling placement
TURP procedure prior to sling placement
Urge predominant incontinence prior to sling placement

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use
Time frame: 3 Months Post Procedure
Evaluate the proportion of subjects with a ≥50% reduction in pads per day use
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use
Time frame: 3 months Post Procedure
Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
Time frame: Baseline
Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit: 0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);
Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit
Time frame: Prospective follow-up to 36 Months Post Procedure
Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.
Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow.
Time frame: Baseline to Prospective Follow Up (up to 36 months)
The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100. The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 1-21. The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7.
Number of Adverse Events Reported Between Arms
Time frame: Prospective follow-up to 36 Months Post Procedure
Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events
Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use
Time frame: Prospective follow-up to 36 Months Post Procedure
Evaluate the proportion of subjects with a ≥50% reduction in pads per day use
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use
Time frame: Prospective follow-up to 36 Months Post Procedure
Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
Time frame: 3 Months Post Procedure
Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit: 0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
Time frame: Prospective follow-up to 36 Months Post Procedure
Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit: 0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);

Results and safety

Results posted to the registry on 30 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AdVance	39	39
AdVance XP	41	41

Primary outcome: Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use

Time frame: 3 Months Post Procedure. Number. Unit: percentage of participants

Measure	AdVance n = 39	AdVance XP n = 41
Value	87.2	97.6

Primary outcome: Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use

Time frame: 3 months Post Procedure. Number. Unit: percentage of subjects

Measure	AdVance n = 39	AdVance XP n = 41
Cured	79.5	82.9
Improved	7.7	14.6
Failed	12.8	2.4

Primary outcome: Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use

Time frame: Baseline. Number. Unit: percentage of subjects

Measure	AdVance n = 39	AdVance XP n = 41
0 Pads per Day	0	0
1 Pad per Day	20.5	4.9
2 Pads per Day	15.4	26.8
3 Pads per Day	20.5	24.4
4 Pads per Day	12.8	7.3
5 or more Pads per Day	30.8	36.6

Primary outcome: Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit

Time frame: Prospective follow-up to 36 Months Post Procedure. Number. Unit: percentage of subjects

Measure	AdVance n = 39	AdVance XP n = 41
<= 10g	59.0	68.3
10g - 50g	30.8	22.0
> 50g	10.3	9.8

Adverse events

Time frame: All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AdVance	2 of 39 (5.1%)	6 of 39 (15.4%)	Not reported
AdVance XP	3 of 41 (7.3%)	7 of 41 (17.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Urinary Incontinence, Stress

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
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Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
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Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ricarda Bauer, MD principal investigator

Ludwig-Maximilians Universität (LMU)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Incontinence, Stress and Intrinsic Sphincter Deficiency, run by American Medical Systems at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use (time frame: 3 Months Post Procedure). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01725984.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015; AzTrials last refreshed its copy on 7 Nov 2026.