A double blinded randomised controlled trial of injection of botulinum toxin versus normal saline into the puborectalis muscle in patients with pelvic floor dyssynergia.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001378-29-GB

Enrollment

Registered

2005-04-21

Start date

2005-05-23

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructed defeacation

Interventions

Trade Name: Botox Product Name: Botox Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Clostridium botulinum type A neurotoxin complex (900kD), 100 units Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Presence of obstructed defeacation according to the Rome II criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Unfit for general anaesthesia, hypersensitivity to Botox, Myaesthenia gravis, Eaton Lamberrt Syndrome

Design outcomes

Primary

Measure	Time frame
Main Objective: Relieve paradoxical puborectalis contraction in obstructed defeacation;Secondary Objective: Improve quality of life and constipation scores;Primary end point(s): Improved defeacation	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026