Trial Outcomes & Findings for A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence (NCT NCT00605826)

NCT ID: NCT00605826

Last Updated: 2020-08-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 206 participants
• Primary outcome timeframe: 6 months after last blinded treatment
• Results posted on: 2020-08-18

Participant Flow

Participant milestones

Measure	NashaDx/Fecal NashaDx/Fecal - 4 syringes each containing 1 mL of product	Sham Sham - 4 empty syringes
Overall Study STARTED	136	70
Overall Study COMPLETED	129	60
Overall Study NOT COMPLETED	7	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence

Baseline characteristics by cohort

Measure	NashaDx/Fecal n=136 Participants NashaDx/Fecal - 4 syringes each containing 1 mL of product	Sham n=70 Participants Sham - 4 empty syringes	Total n=206 Participants Total of all reporting groups
Age, Continuous	60.6 years n=93 Participants	59.2 years n=4 Participants	60.1 years n=27 Participants
Sex: Female, Male Female	122 Participants n=93 Participants	61 Participants n=4 Participants	183 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	9 Participants n=4 Participants	23 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6 months after last blinded treatment

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

Outcome measures

Measure	NashaDx/Fecal n=136 Participants NashaDx/Fecal - 4 syringes each containing 1 mL of product	Sham n=70 Participants Sham - 4 empty syringes
Percentage of Participants Who Are Responder50.	71 Participants	21 Participants

PRIMARY outcome

Timeframe: 12 months after last treatment

Population: This outcome measure was only analyzed for the NASHA/Dx group.

Response to treatment at 12 months was defined as a ≥ 25 % reduction in the number of fecal incontinence episodes compared to baseline (Responder25).

Outcome measures

Measure	NashaDx/Fecal n=136 Participants NashaDx/Fecal - 4 syringes each containing 1 mL of product	Sham Sham - 4 empty syringes
Percentage of Participants Who Are Responder25.	69.1 percentage of participants	—

SECONDARY outcome

Timeframe: up to 6 months after last treatment

The number of incontinence episodes collected from a participant incontinence diary spanning a period of 14 days prior to each of the study visits.

Outcome measures

Measure	NashaDx/Fecal n=136 Participants NashaDx/Fecal - 4 syringes each containing 1 mL of product	Sham n=70 Participants Sham - 4 empty syringes
Number of Fecal Incontinence Episodes	16.28 number of episodes Standard Error 2.15	18.53 number of episodes Standard Error 5.56

SECONDARY outcome

Timeframe: up to 6 months after last treatment

The number of days with no fecal incontinence episodes (incontinence free days).

Outcome measures

Measure	NashaDx/Fecal n=136 Participants NashaDx/Fecal - 4 syringes each containing 1 mL of product	Sham n=70 Participants Sham - 4 empty syringes
Number of Incontinence Free Days	7.6 incontinence free days Interval 6.68 to 8.52	6.48 incontinence free days Interval 5.41 to 7.56

SECONDARY outcome

Timeframe: up to 6 months after last treatment

Population: This outcome measure was only analyzed for the NASHA/Dx group.

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.

Outcome measures

Measure	NashaDx/Fecal n=136 Participants NashaDx/Fecal - 4 syringes each containing 1 mL of product	Sham Sham - 4 empty syringes
Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL). Lifestyle domain	0.29 units on a scale Standard Error 0.05	—
Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL). Coping/Behavior domain	0.42 units on a scale Standard Error 0.05	—
Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL). Depression/Self perception domain	0.30 units on a scale Standard Error 0.05	—
Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL). Embarrassment domain	0.45 units on a scale Standard Error 0.06	—

SECONDARY outcome

Timeframe: up to 6 months after last treatment

Population: This outcome measure was only analyzed for the NASHA/Dx group.

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)

Outcome measures

Measure	NashaDx/Fecal n=136 Participants NashaDx/Fecal - 4 syringes each containing 1 mL of product	Sham Sham - 4 empty syringes
Cleveland Clinic Florida Incontinence Score (CCFIS).	-2.45 units on a scale Standard Error 0.31	—

Adverse Events

Overall

Serious events: 31 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Measure	Overall n=206 participants at risk Adverse events were assessed overall and not by randomized treatment group
Gastrointestinal disorders Abdominal pain	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Blood and lymphatic system disorders Anaemia	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Vascular disorders Arterial senosis limb	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Musculoskeletal and connective tissue disorders Arthralgia	0.97% 2/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Cardiac disorders Atrial fibrillation	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
General disorders Back pain	0.97% 2/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Vascular disorders Carotid artery stenosis	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Nervous system disorders Cerebrovascular accident	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
General disorders Chest pain	0.97% 2/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Gastrointestinal disorders Cholelithiasis	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Injury, poisoning and procedural complications Concussion	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
General disorders Enterocele	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Gastrointestinal disorders Gastroenteritis	0.97% 2/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Gastrointestinal disorders Haemorrhoids	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.97% 2/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple endocrine adenomatosis Type II	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Gastrointestinal disorders Nausea	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Infections and infestations Pneumonia	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Injury, poisoning and procedural complications Post procedural haematoma	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Gastrointestinal disorders Rectal prolapse	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Gastrointestinal disorders Rectal abscess	0.97% 2/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Gastrointestinal disorders E. coli bacteremia	0.49% 1/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.

Other adverse events

Measure	Overall n=206 participants at risk Adverse events were assessed overall and not by randomized treatment group
General disorders Injection site haemorrhage	7.8% 16/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Gastrointestinal disorders Proctalgia	16.0% 33/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
Gastrointestinal disorders Rectal haemorrhage	7.3% 15/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.
General disorders Pyrexia	6.8% 14/206 • 36 months Adverse events were assessed in all treated subjects and not by treatment group.

Additional Information

Study Director

Bausch Health

Email: susan.harris@bauschhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee Contact sponsor directly for details.
• Publication restrictions are in place

Restriction type: OTHER