WithdrawnPhase 4

Pharmacological vs Surgical Treatment for Mixed Incontinence

Stopped: it stopped at a regulatory stage

United Kingdom0Started 2007-09

Plain-language 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.

Who can participate

Age range35 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

improvement in subjective and objective measures of urinary incontinence

Timeframe: 3 months

Trial details

NCT IDNCT00523068

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-01

View on ClinicalTrials.gov More Mixed Urinary Incontinence trials

Plain-language summary

Who can participate

Age range35 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Pharmacological vs Surgical Treatment for Mixed Incontinence

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Pharmacological vs Surgical Treatment for Mixed Incontinence

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria