Pharmacological vs Surgical Treatment for Mixed Incontinence

NCT00523068 | Withdrawn Phase 4

• 1 other identifier: 07/s0501/26
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with symptoms of mixed incontinence (loss of urine associated with coughing/sneezing/laughing, and loss of urine associated with the strong urge to void), is surgical treatment with tension free vaginal tape or pharmacological treatment with tolterodine more effective? What are the parameters predictive of success or failure with either forms of treatment? What are the parameters predictive of the necessity for further treatment after primary treatment? Patients will be randomised to having surgical or pharmacological treatment for their mixed incontinence symptoms. They will be assessed subjectively and objectively pre-treatment and after treatment at intervals up to 3 months.

Conditions

Mixed Urinary Incontinence; Urinary Incontinence, Stress; Urinary Incontinence, Urge

Keywords

overactive bladder; stress urinary incontinence; detrusor overactivity; urodynamics

Outcome Measures

Primary Outcomes (1)

• improvement in subjective and objective measures of urinary incontinence

  3 months

Secondary Outcomes (2)

• assessment of pre-treatment predictors of success or failure of treatment

  3 months

• assessment of pre-treatment predictors of requirement for alternative treatment

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Tension Free Vaginal Tape

Procedure: tension free vaginal tape

2

ACTIVE COMPARATOR

Tolterodine tartrate 4mg

Drug: Tolterodine

Interventions

Tolterodine DRUG

Also known as: detrusitol XL

2

tension free vaginal tape PROCEDURE

1

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be female as this is a urogynaecology study.
• An age of between 35 and 70 years. This takes into account that incontinence tends to prevail in women with advancing years. Younger women may be planning to start a family which precludes them from participating.
• Clinical urodynamic evidence of mixed incontinence with prevalence of symptoms of stress incontinence assessed by means of a specific questionnaire and visual analog scale (VAS). The study is assessing the treatment of mixed incontinence and the patients will have to have evidence of this which is provided by their symptoms.
• Candidates for corrective surgery of the component of sphincter defect with Ba \< - 1 according to the International Continence Society (ICS) classification of genital prolapse.
• Patients capable of filling in the micturition diary, the VAS, and the pathology specific quality of life questionnaire, the Kings Health Questionnaire. These form part of the continuing assessment of effectiveness of treatment.
• Patients capable of understanding and signing an informed written consent form for participating in the trial. If patients are unable to give their consent for the procedures and investigations they cannot be ethically recruited.
• Patients who accept not to give birth vaginally in the future, so as not to jeopardize the results of the surgical operation.

You may not qualify if:

• Contraindications for using anti-cholinergic agents (urinary retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe ulcerative colitis, toxic megacolon). Anticholinergics form one group of the patients and inability to take these drugs therefore precludes them from participating.
• Ascertained hypersensitivity to tolterodine or any of the excipients. For the above reason.
• Patients with urinary tract infections (UTI) during the run-in period.
• Patients with recurrent urinary tract infections (\> 5 in the past 12 months).
• Patients with diagnosed interstitial cystitis.
• These compromise the results obtained.
• Patients with haematuria of uncertain origin. These patients need urgent investigation of these signs with procedures that are not included in the study.
• Patients on treatment with anti-cholinergic agents of other drugs acting on detrusor instability. This will compromise the results of the study if for example these patients are randomised into the surgical group.
• Patients on diuretics. This affect their urinary behaviour.
• Patients on concomitant treatment with potent CYP 34A inhibitors, such as macrolide antibiotics or antimycotic agents.
• Patients who have undergone previous surgery on the distal urinary tract (with the exception of hysterectomy).
• Patients who do not have adequate contraceptive cover or patients who are breast-feeding. For reasons of avoiding pregnancy during the study.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Demetri C Panayi

London, sw18 4qr, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge; Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate; Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols; Prostheses and Implants; Equipment and Supplies

Study Officials

• Vikram Khullar

  Imperial College London

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 30, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

GB (1)