Trial Outcomes & Findings for Infracoccygeal Botox for Dyssynergia (NCT NCT04879524)

Results Overview

The investigator will record the number of times the puborectalis muscle is successfully identified using ultrasound scan (muscle seen to contract on volition) and pre-injection EMG (change in EMG waveform on volitional contraction) by the radiologist and neurologist, respectively, at the beginning of the injection procedure.

Recruitment status

COMPLETED

Target enrollment

8 participants

Primary outcome timeframe

Visit 3: week 18

Results posted on

2025-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Percutaneous Infracoccygeal Botulinum Toxin Injection to Puborectalis 100 units of Botulinum toxin type A (Botox, Allergan, Ireland) injection into the puborectalis muscle to each side of the midline, achieving a total of 200 units Percutaneous infracoccygeal Botulinum toxin injection to puborectalis: The intervention is an injection of 200 units of Botulinum toxin type A in to the puborectalis muscle under ultrasound guidance. In the prone position, the puborectalis muscle will be identified below the coccyx using ultrasound. After skin preparation using 70% Isopropyl Alcohol Pad, and up to 5ml of local anaesthetic (1% lidocaine), an electromyography (EMG) needle will be inserted and the puborectalis muscle stimulated using a current to confirm correct needle position. 200 units of BTXA (Botox, Allergan, Ireland) prepared in 2 ml of saline solution and drawn up using a 2ml syringe. 1ml (100 units) of BTXA solution is injected through the EMG needle into the puborectalis muscle to each side of the midline, achieving a total of 200 units. The needle is withdrawn, and the procedure is complete.
Overall Study STARTED	8
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Percutaneous Infracoccygeal Botulinum Toxin Injection to Puborectalis n=8 Participants 100 units of Botulinum toxin type A (Botox, Allergan, Ireland) injection into the puborectalis muscle to each side of the midline, achieving a total of 200 units Percutaneous infracoccygeal Botulinum toxin injection to puborectalis: The intervention is an injection of 200 units of Botulinum toxin type A in to the puborectalis muscle under ultrasound guidance. In the prone position, the puborectalis muscle will be identified below the coccyx using ultrasound. After skin preparation using 70% Isopropyl Alcohol Pad, and up to 5ml of local anaesthetic (1% lidocaine), an electromyography (EMG) needle will be inserted and the puborectalis muscle stimulated using a current to confirm correct needle position. 200 units of BTXA (Botox, Allergan, Ireland) prepared in 2 ml of saline solution and drawn up using a 2ml syringe. 1ml (100 units) of BTXA solution is injected through the EMG needle into the puborectalis muscle to each side of the midline, achieving a total of 200 units. The needle is withdrawn, and the procedure is complete.
Age, Categorical <=18 years	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants
Sex: Female, Male Female	1 Participants n=8 Participants
Sex: Female, Male Male	7 Participants n=8 Participants

PRIMARY outcome

Timeframe: Visit 3: week 18

The investigator will record the number of times the puborectalis muscle is successfully identified using ultrasound scan (muscle seen to contract on volition) and pre-injection EMG (change in EMG waveform on volitional contraction) by the radiologist and neurologist, respectively, at the beginning of the injection procedure.

Outcome measures

Outcome measures
Measure	Percutaneous Infracoccygeal Botulinum Toxin Injection to Puborectalis n=8 Participants 100 units of Botulinum toxin type A (Botox, Allergan, Ireland) injection into the puborectalis muscle to each side of the midline, achieving a total of 200 units Percutaneous infracoccygeal Botulinum toxin injection to puborectalis: The intervention is an injection of 200 units of Botulinum toxin type A in to the puborectalis muscle under ultrasound guidance. In the prone position, the puborectalis muscle will be identified below the coccyx using ultrasound. After skin preparation using 70% Isopropyl Alcohol Pad, and up to 5ml of local anaesthetic (1% lidocaine), an electromyography (EMG) needle will be inserted and the puborectalis muscle stimulated using a current to confirm correct needle position. 200 units of BTXA (Botox, Allergan, Ireland) prepared in 2 ml of saline solution and drawn up using a 2ml syringe. 1ml (100 units) of BTXA solution is injected through the EMG needle into the puborectalis muscle to each side of the midline, achieving a total of 200 units. The needle is withdrawn, and the procedure is complete.
The Rate of Identification of Puborectalis During Ultrasound Scan	8 Participants

PRIMARY outcome

Timeframe: Visit 3: week 18

The investigator will record the time (in minutes) taken to for the radiologist to complete the injection procedure

Outcome measures

Outcome measures
Measure	Percutaneous Infracoccygeal Botulinum Toxin Injection to Puborectalis n=8 Participants 100 units of Botulinum toxin type A (Botox, Allergan, Ireland) injection into the puborectalis muscle to each side of the midline, achieving a total of 200 units Percutaneous infracoccygeal Botulinum toxin injection to puborectalis: The intervention is an injection of 200 units of Botulinum toxin type A in to the puborectalis muscle under ultrasound guidance. In the prone position, the puborectalis muscle will be identified below the coccyx using ultrasound. After skin preparation using 70% Isopropyl Alcohol Pad, and up to 5ml of local anaesthetic (1% lidocaine), an electromyography (EMG) needle will be inserted and the puborectalis muscle stimulated using a current to confirm correct needle position. 200 units of BTXA (Botox, Allergan, Ireland) prepared in 2 ml of saline solution and drawn up using a 2ml syringe. 1ml (100 units) of BTXA solution is injected through the EMG needle into the puborectalis muscle to each side of the midline, achieving a total of 200 units. The needle is withdrawn, and the procedure is complete.
Procedure Duration	5 minutes Interval 5.0 to 10.0

PRIMARY outcome

Timeframe: Visit 3: week 18

The investigator will record any procedure or patient related factors which prevented a successful injection, e.g. body habitus or equipment failure.

Outcome measures

Outcome measures
Measure	Percutaneous Infracoccygeal Botulinum Toxin Injection to Puborectalis n=8 Participants 100 units of Botulinum toxin type A (Botox, Allergan, Ireland) injection into the puborectalis muscle to each side of the midline, achieving a total of 200 units Percutaneous infracoccygeal Botulinum toxin injection to puborectalis: The intervention is an injection of 200 units of Botulinum toxin type A in to the puborectalis muscle under ultrasound guidance. In the prone position, the puborectalis muscle will be identified below the coccyx using ultrasound. After skin preparation using 70% Isopropyl Alcohol Pad, and up to 5ml of local anaesthetic (1% lidocaine), an electromyography (EMG) needle will be inserted and the puborectalis muscle stimulated using a current to confirm correct needle position. 200 units of BTXA (Botox, Allergan, Ireland) prepared in 2 ml of saline solution and drawn up using a 2ml syringe. 1ml (100 units) of BTXA solution is injected through the EMG needle into the puborectalis muscle to each side of the midline, achieving a total of 200 units. The needle is withdrawn, and the procedure is complete.
Procedure Limitations	0 Participants

SECONDARY outcome

Timeframe: From visit 3 to visit 6: week 18 to 42

Any adverse events reported by the patients or their clinician following the injection

Outcome measures

Outcome measures
Measure	Percutaneous Infracoccygeal Botulinum Toxin Injection to Puborectalis n=8 Participants 100 units of Botulinum toxin type A (Botox, Allergan, Ireland) injection into the puborectalis muscle to each side of the midline, achieving a total of 200 units Percutaneous infracoccygeal Botulinum toxin injection to puborectalis: The intervention is an injection of 200 units of Botulinum toxin type A in to the puborectalis muscle under ultrasound guidance. In the prone position, the puborectalis muscle will be identified below the coccyx using ultrasound. After skin preparation using 70% Isopropyl Alcohol Pad, and up to 5ml of local anaesthetic (1% lidocaine), an electromyography (EMG) needle will be inserted and the puborectalis muscle stimulated using a current to confirm correct needle position. 200 units of BTXA (Botox, Allergan, Ireland) prepared in 2 ml of saline solution and drawn up using a 2ml syringe. 1ml (100 units) of BTXA solution is injected through the EMG needle into the puborectalis muscle to each side of the midline, achieving a total of 200 units. The needle is withdrawn, and the procedure is complete.
Rate of Adverse Events	0 Participants

SECONDARY outcome

Timeframe: Visit 3: week 18

Population: Reported pain

Following the procedure, the patient will complete a post-procedure questionnaire. * The patient is asked to give their response to the statement "the procedure was painful" on a 5-point rating scale (strongly agree/ agree/ neutral/ disagree/ strongly disagree). * The patient is asked to give their response to the statement "the procedure was comfortable" on a 5-point rating scale (strongly agree/ agree/ neutral/ disagree/ strongly disagree).

Outcome measures

Outcome measures
Measure	Percutaneous Infracoccygeal Botulinum Toxin Injection to Puborectalis n=8 Participants 100 units of Botulinum toxin type A (Botox, Allergan, Ireland) injection into the puborectalis muscle to each side of the midline, achieving a total of 200 units Percutaneous infracoccygeal Botulinum toxin injection to puborectalis: The intervention is an injection of 200 units of Botulinum toxin type A in to the puborectalis muscle under ultrasound guidance. In the prone position, the puborectalis muscle will be identified below the coccyx using ultrasound. After skin preparation using 70% Isopropyl Alcohol Pad, and up to 5ml of local anaesthetic (1% lidocaine), an electromyography (EMG) needle will be inserted and the puborectalis muscle stimulated using a current to confirm correct needle position. 200 units of BTXA (Botox, Allergan, Ireland) prepared in 2 ml of saline solution and drawn up using a 2ml syringe. 1ml (100 units) of BTXA solution is injected through the EMG needle into the puborectalis muscle to each side of the midline, achieving a total of 200 units. The needle is withdrawn, and the procedure is complete.
Patient's Level Pain and Comfort Assessed at Post-procedure	2 Participants

SECONDARY outcome

Timeframe: Visit 3: week 18

The number of patients who answered Yes when asked if they will be willing to undergo a repeat procedure (yes/no) in a post-procedure questionnaire.

Outcome measures

Outcome measures
Measure	Percutaneous Infracoccygeal Botulinum Toxin Injection to Puborectalis n=8 Participants 100 units of Botulinum toxin type A (Botox, Allergan, Ireland) injection into the puborectalis muscle to each side of the midline, achieving a total of 200 units Percutaneous infracoccygeal Botulinum toxin injection to puborectalis: The intervention is an injection of 200 units of Botulinum toxin type A in to the puborectalis muscle under ultrasound guidance. In the prone position, the puborectalis muscle will be identified below the coccyx using ultrasound. After skin preparation using 70% Isopropyl Alcohol Pad, and up to 5ml of local anaesthetic (1% lidocaine), an electromyography (EMG) needle will be inserted and the puborectalis muscle stimulated using a current to confirm correct needle position. 200 units of BTXA (Botox, Allergan, Ireland) prepared in 2 ml of saline solution and drawn up using a 2ml syringe. 1ml (100 units) of BTXA solution is injected through the EMG needle into the puborectalis muscle to each side of the midline, achieving a total of 200 units. The needle is withdrawn, and the procedure is complete.
The Number of Patient Indicating Yes, They Would be Willing to Undergo a Repeat Procedure	8 Participants

Adverse Events

Percutaneous Infracoccygeal Botulinum Toxin Injection to Puborectalis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

P Chaichanavichkij

Queen Mary University of London

Phone: 020 7882 8752

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place