NCT00605826

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable

Geographic Reach
4 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 31, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2009

Completed
10.7 years until next milestone

Results Posted

Study results publicly available

August 18, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

3.2 years

First QC Date

January 9, 2008

Results QC Date

August 4, 2020

Last Update Submit

August 4, 2020

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Who Are Responder50.

    Percentage of participants who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50).

    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).

    12 months after last treatment

Secondary Outcomes (4)

  • Number of Fecal Incontinence Episodes

    up to 6 months after last treatment

  • Number of Incontinence Free Days

    up to 6 months after last treatment

  • Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL).

    up to 6 months after last treatment

  • Cleveland Clinic Florida Incontinence Score (CCFIS).

    up to 6 months after last treatment

Study Arms (3)

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).

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).

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).

Device: NASHA/Dx (Solesta) GelDevice: Sham Injection

Interventions

NASHA/Dx (Solesta) GelDEVICE

Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.

Also known as: Solesta
Blinded Sham Inject. at Randomization + NASHA/Dx Gel at 6 mo.Blinded injection of NASHA/Dx gel at randomization.
Sham InjectionDEVICE

Sham injection at the start of the blinded phase.

Blinded Sham Inject. at Randomization + NASHA/Dx Gel at 6 mo.Blinded sham inject. at randomization

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of California, San Francisco, Center for Pelvic Physiology, Dept. of Surgery

San Francisco, California, 94115, United States

Location

University of South Florida College of Medicine, Tampa General Hospital

Tampa, Florida, 33601, United States

Location

Lahey Clinic, Department of Colon & Rectal Surgery

Burlington, Massachusetts, 01805, United States

Location

Colon & Rectal Surgery Associates

Minneapolis, Minnesota, 55454, United States

Location

St. Luke's/Roosevelt Hospital

New York, New York, 10019, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Colorectal Surgical Associates

Houston, Texas, 77054, United States

Location

Salt Lake Research/Center for Colon Rectal Disease

Salt Lake City, Utah, 84107, United States

Location

Chirurgische Klinik Mit Poliklinik, FAU Erlangen-Nurnberg

Erlangen, 910 54, Germany

Location

Kirurgmottagningen Universitetssjukhuset MAS

Malmo, 205 02, Sweden

Location

Kirurgmottagningen, Danderyds Sjukhus

Stockholm, 182 88, Sweden

Location

Kirurgkliniken, Uppsala Akademiska Sjukhus

Uppsala, 751 85, Sweden

Location

Castle Hill Hospital, Department of Academic Surgery

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 21420555DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Study Director
Organization
Bausch Health
susan.harris@bauschhealth.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 31, 2008

Study Start

September 7, 2006

Primary Completion

November 23, 2009

Study Completion

November 23, 2009

Last Updated

August 18, 2020

Results First Posted

August 18, 2020

Record last verified: 2020-08

Locations

SE(3)GB(1)DE(1)US(8)