Fecal IncontinenceNCT00605826
A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence
A study testing NASHA/Dx (Solesta) Gel in people with Fecal Incontinence, run by Bausch Health Americas, Inc. at 13 sites in 4 countries.
Trial summary
The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- NASHA/Dx (Solesta) Gel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 7 Sep 2006to 23 Nov 2009
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years of age, male or female.
- Screening fecal incontinence severity score (CCFIS).
- Fecal incontinence episodes over a 14-day period.
- Failed conservative treatment for fecal incontinence.
Who cannot join
- Complete external sphincter disruption.
- Significant anorectal disease.
- Anorectal surgery within the last 12 months prior to the study.
- Active Inflammatory Bowel Disease (IBD).
- Immunodeficiency or receiving immunosuppressive therapy.
- Malignancies in remission for less than 2 years prior to the study.
Show all 14Show fewer
- Bleeding disorders or receiving anticoagulant therapy.
- Chemotherapy within the last 12 months prior to the study.
- Prior Pelvic radiotherapy.
- Women who are pregnant or breast-feeding, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study.
- Women within one year post partum.
- Participation in any other clinical study within 3 month prior to the study.
- Hypersensitivity to hyaluronic acid containing products.
- Other severe conditions or in other ways unsuitable to participate according to investigator judgement.
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
United States8 sites
Lahey Clinic, Department of Colon & Rectal Surgery
Burlington, Massachusetts, 01805
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Colorectal Surgical Associates
Houston, Texas, 77054
Colon & Rectal Surgery Associates
Minneapolis, Minnesota, 55454
St. Luke's/Roosevelt Hospital
New York, New York, 10019
Salt Lake Research/Center for Colon Rectal Disease
Salt Lake City, Utah, 84107
University of California, San Francisco, Center for Pelvic Physiology, Dept. of Surgery
San Francisco, California, 94115
University of South Florida College of Medicine, Tampa General Hospital
Tampa, Florida, 33601
Sweden3 sites
Kirurgmottagningen Universitetssjukhuset MAS
Malmö, 205 02
Kirurgmottagningen, Danderyds Sjukhus
Stockholm, 182 88
Kirurgkliniken, Uppsala Akademiska Sjukhus
Uppsala, 751 85
Germany1 site
Chirurgische Klinik Mit Poliklinik, FAU Erlangen-Nurnberg
Erlangen, 910 54
United Kingdom1 site
Castle Hill Hospital, Department of Academic Surgery
Cottingham, East Yorkshire, HU16 5JQ
About this study
Official title: A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence
The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase.
Read the detailed description
Subjects will be given up to 2 treatments of NASHA/Dx or sham and followed for 6 months from last treatment (ie, one retreatment is permitted at 1 month after the first injection) in the blinded phase of the study. At Month 6, the open phase of the study will begin and subjects on sham will be offered open-label treatment with NASHA/Dx.
Subjects who receive NASHA/Dx at the start of the blinded phase will be followed for up to 36 months from last treatment in the blinded phase. Subjects who receive sham at the start of the blinded phase and then receive open-label NASHA/Dx at Month 6 (start of the open phase) will be followed for another 24 months (equivalent to approximately 30 months from randomization) from last treatment in the open phase of the study.
- Conditions
- Fecal Incontinence
- Being tested
- NASHA/Dx (Solesta) Gel, Sham Injection
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NASHA/Dx (Solesta) GelDevice
Also called Solesta
Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.
Sham InjectionDevice
Sham injection at the start of the blinded phase.
| Study group | Role | What they receive |
|---|---|---|
| Blinded injection of NASHA/Dx gel at randomization. | Experimental | Blinded injection of NASHA/Dx (Solesta) Gel. For each treatment, a series of 4 equally spaced injections with 1 mL of Solesta into the anal canal. Subjects will be followed for 6 months during the blinded phase. During a subsequent open phase, these subjects will be followed to Month 36 (ie, for an additional 30 months). Receives: Device: NASHA/Dx (Solesta) Gel |
| Blinded sham inject. at randomization | Sham comparator | Blinded sham injection (needle stick with empty syringes). For each treatment, a series of 4 equally spaced Sham injections (needle sticks) into the anal canal. Subjects will be followed for 6 months during the blinded phase.
Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months). Receives: Device: Sham Injection |
| Blinded Sham Inject. at Randomization + NASHA/Dx Gel at 6 mo. | Other | Blinded sham injection at randomization. Subjects will be followed for 6 months during the blinded phase.
Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months). Receives: Device: NASHA/Dx (Solesta) Gel; Device: Sham Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Are Responder50.
Percentage of participants who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50).
Measured: 6 months after last blinded treatment
Percentage of Participants Who Are Responder25.
Response to treatment at 12 months was defined as a ≥ 25 % reduction in the number of fecal incontinence episodes compared to baseline (Responder25).
Measured: 12 months after last treatment
Secondary outcomes (4)
Number of Fecal Incontinence Episodes
The number of incontinence episodes collected from a participant incontinence diary spanning a period of 14 days prior to each of the study visits.
Measured: up to 6 months after last treatment
Number of Incontinence Free Days
The number of days with no fecal incontinence episodes (incontinence free days).
Measured: up to 6 months after last treatment
Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL).
The disease-specific Fecal Incontinence Quality of Life (FIQL) questionnaire is designed to capture the impact of treatment on quality of life for participants suffering from fecal incontinence as it pertains to 4 domains: Lifestyle, Coping/Behavior, Depression/Self perception and Embarrassment. The more the subject is affected by fecal incontinence the lower the value. Hence, a positive change from baseline indicates improvement. Scores range from 1 to 4.
Measured: up to 6 months after last treatment
Cleveland Clinic Florida Incontinence Score (CCFIS).
Cleveland Clinic Florida Incontinence Score (CCFIS) score was based on a participant interview using standardized questions regarding incidence and type of incontinence (solid, liquid or gas), pad usage and lifestyle alterations during the past month. The score ranged from 0 (perfect) to 20 (complete incontinence)
Measured: up to 6 months after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study start7 Sep 2006
- Primary completion23 Nov 2009
- Study completion23 Nov 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oceana Therapeutics, Inc., Galderma R&D
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605826
- Sponsor's protocol ID
- 33DA0404
- Status last verified
- Aug 2020
- First submitted
- 9 Jan 2008
- Last updated
- 18 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Graf W, Mellgren A, Matzel KE, Hull T, Johansson C, Bernstein M; NASHA Dx Study Group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial. Lancet. 2011 Mar 19;377(9770):997-1003. doi: 10.1016/S0140-6736(10)62297-0.
PubMed 21420555
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence
- ClinicalTrials.gov ID
- NCT00605826
- Acronym / sponsor ID
- 33DA0404
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Oceana Therapeutics, Inc., Galderma R&D
- Study start
- 7 Sep 2006 (actual)
- Primary completion
- 23 Nov 2009 (actual)
- Study completion
- 23 Nov 2009 (actual)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Posted 18 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase.
Detailed description
Subjects will be given up to 2 treatments of NASHA/Dx or sham and followed for 6 months from last treatment (ie, one retreatment is permitted at 1 month after the first injection) in the blinded phase of the study. At Month 6, the open phase of the study will begin and subjects on sham will be offered open-label treatment with NASHA/Dx.
Subjects who receive NASHA/Dx at the start of the blinded phase will be followed for up to 36 months from last treatment in the blinded phase. Subjects who receive sham at the start of the blinded phase and then receive open-label NASHA/Dx at Month 6 (start of the open phase) will be followed for another 24 months (equivalent to approximately 30 months from randomization) from last treatment in the open phase of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blinded injection of NASHA/Dx gel at randomization. | Experimental | Device: NASHA/Dx (Solesta) GelBlinded injection of NASHA/Dx (Solesta) Gel. For each treatment, a series of 4 equally spaced injections with 1 mL of Solesta into the anal canal. Subjects will be followed for 6 months during the blinded phase. During a subsequent open phase, these subjects will be followed to Month 36 (ie, for an additional 30 months). |
| Blinded sham inject. at randomization | Sham comparator | Device: Sham InjectionBlinded sham injection (needle stick with empty syringes). For each treatment, a series of 4 equally spaced Sham injections (needle sticks) into the anal canal. Subjects will be followed for 6 months during the blinded phase. Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months). |
| Blinded Sham Inject. at Randomization + NASHA/Dx Gel at 6 mo. | Other | Device: NASHA/Dx (Solesta) Gel, Device: Sham InjectionBlinded sham injection at randomization. Subjects will be followed for 6 months during the blinded phase. Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years of age, male or female.
- Screening fecal incontinence severity score (CCFIS).
- Fecal incontinence episodes over a 14-day period.
- Failed conservative treatment for fecal incontinence.
Key exclusion criteria (14 listed)
- Complete external sphincter disruption.
- Significant anorectal disease.
- Anorectal surgery within the last 12 months prior to the study.
- Active Inflammatory Bowel Disease (IBD).
- Immunodeficiency or receiving immunosuppressive therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NASHA/Dx (Solesta) GelAlso: SolestaInjection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase. | Device | Blinded Sham Inject. at Randomization + NASHA/Dx Gel at 6 mo., Blinded injection of NASHA/Dx gel at randomization. |
| Sham InjectionSham injection at the start of the blinded phase. | Device | Blinded Sham Inject. at Randomization + NASHA/Dx Gel at 6 mo., Blinded sham inject. at randomization |
Primary outcome
Percentage of Participants Who Are Responder50.
Time frame: 6 months after last blinded treatment
Percentage of participants who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50).
Percentage of Participants Who Are Responder25.
Time frame: 12 months after last treatment
Response to treatment at 12 months was defined as a ≥ 25 % reduction in the number of fecal incontinence episodes compared to baseline (Responder25).
4 secondary outcomes
Number of Fecal Incontinence Episodes
Time frame: up to 6 months after last treatment
Number of Incontinence Free Days
Time frame: up to 6 months after last treatment
Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL).
Time frame: up to 6 months after last treatment
Cleveland Clinic Florida Incontinence Score (CCFIS).
Time frame: up to 6 months after last treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21420555Graf W, Mellgren A, Matzel KE, Hull T, Johansson C, Bernstein M; NASHA Dx Study Group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial. Lancet. 2011 Mar 19;377(9770):997-1003. doi: 10.1016/S0140-6736(10)62297-0.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NASHA/Dx (Solesta) Gel in people with Fecal Incontinence, run by Bausch Health Americas, Inc. at 13 sites in 4 countries.
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 4 inclusion and 14 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 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Sweden, Germany, United Kingdom. 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. Some participants in this study may receive a placebo. 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 18 Aug 2020). 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 Participants Who Are Responder50. (time frame: 6 months after last blinded treatment). The study lists 2 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 NCT00605826, which also lists 1 linked publication.
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 18 Aug 2020.